title: A 10-week Randomised, DB, PG, PC Phase 2 Study to Investigate the Extent of Symptom Relief and the Safety and Tolerability of SMP-986 (20, 40, 80 and 120 mg) Administered Once Daily for 8 Weeks to Patients With Overactive Bladder Syndrome

summary: SMP-986 is a compound being developed for the treatment of overactive bladder syndrome (OABS). This clinical study is designed to test the hypothesis that SMP-986 at doses of 20mg, 40mg, 80mg or 120mg provides greater symptom relief in OABS compared to placebo. The hypothesis will be tested by measuring the change in mean voids/24 hrs after treatment with SMP-986 compared to placebo, as well comparing the change in: the severity of urgency episodes, mean number of urgency episodes/24 hr, mean number of incontinence episodes/24 hr and the mean void volume/void between SMP-986 and placebo.

lead_sponsor: Sunovion

location_country:
Poland
Spain
Latvia
United Kingdom
Estonia
Lithuania
United States
France
Germany

location_facility: Southern Research Group, Centre Point Boulevard

location_facility: Clinical Dept of Urology, Medical Postgraduate Education

location_facility: San Bernadino Urological Association Medical Group

location_facility: Gem. Praxis fur Urologie und Mannerheilkunde


title: Controlled, Double-Blind, Randomised, Dose-Ranging Study on the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement- ODIXa-HIP2 Study BAY 59-7939

summary: Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE. The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk, but heparins have to be applied by injections below the skin. The purpose of this study was to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the licensed drug enoxaparin and to find the optimal dose of BAY 59-7939 for the anticipated phase III trials. Enoxaparin, a so-called low molecular weight heparin, is approved and widely used in the area of thromboprophylaxis and was given once daily subcutaneously. In this study 5 different doses of the investigational drug BAY 59-7939 were tested in comparison to Enoxaparin. The following doses of BAY 59-7939 were tested: 2.5 mg twice daily (5 mg total daily dose); 5 mg twice daily (10 mg total daily dose), 10 mg twice daily (20 mg total daily dose), 20 mg twice daily (40 mg total daily dose) and 30 mg twice daily ( 60 mg total daily dose). This study ran for approximately 7 months in a number of countries. In total, 726 patients were enrolled in this study.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

lead_sponsor: Bayer

location_country:
Denmark
Poland
Spain
Italy
Austria
Netherlands
United Kingdom
Sweden
France
Israel
Belgium
Norway
Germany

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Randomised,Double-blind,Placebo-controlled,Parallel Group Study TroVax, Added to First-line Standard of Care, Prolongs Survival of Patients With Locally Advanced or Metastatic Clear Cell Renal Adenocarcinoma.

summary: The purpose of this study is to investigate whether TroVax, when added to first line standard of care therapy, improves survival for patients with locally advanced or metastatic clear cell renal adenocarcinoma.

primary_purpose: Treatment

ReferenceType: result

ReferenceCitation: Amato RJ, Hawkins RE, Kaufman HL, Thompson JA, Tomczak P, Szczylik C, McDonald M, Eastty S, Shingler WH, de Belin J, Goonewardena M, Naylor S, Harrop R. Vaccination of metastatic renal cancer patients with MVA-5T4: a randomized, double-blind, placebo-controlled phase III study. Clin Cancer Res. 2010 Nov 15;16(22):5539-47. doi: 10.1158/1078-0432.CCR-10-2082. Epub 2010 Sep 29.

lead_sponsor: Oxford BioMedica

location_country:
Poland
Spain
United Kingdom
Russian Federation
Ukraine
United States
Israel
France
Romania
Germany

location_facility: IIndependent Public Hospital #1- , Oncology and Radiotherapy Dept

location_facility: University Minnesota Fairview Medical Center

location_facility: State Medical Institution of Healthcare: Clinical Oncological Center under the Ministry of Healthcare of the Republic of Tatarstan, Chemotherapy Department

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Russian State Medical University under the Federal Agency for Healthcare and Social Development, Department of Radiology Daignostics and Radiology Therapy

location_facility: Little Rock Hematology / Oncology Associates, P.A.

location_facility: "Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic

location_facility: Maria Sklodowska-Curie Memorial Institute, Oncology Center in Warsaw, Clinic of Neoplasms of Urinary System

location_facility: Chelyabinsk Regional Oncological Center, Chemotherapy Department

location_facility: State Medical Institution: Arkhangelsk Regional Clinical Oncological Center, Surgery Department 7.

location_facility: St. Petersburg State Medical Institution: Municipal Multi-Speciality Hospital #2, Department of Functional Diagnostics

location_facility: Dnepropetrovsk State Medical Academy, Department of Urology

location_facility: State Medical Institution: Omsk Regional Oncological Center, Chemotherapy Department

location_facility: Holycross Oncology Center in Kielce, Department of Urology

location_facility: St. Petersburg State Medical Institution: Municipal Hospital #15, Urology Department

location_facility: Maria Sklodowska-Curie Memorial Institute, Oncology Center Kraków Clinic Systemic and Generalized Neoplasms

location_facility: Kharkov Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology Department

location_facility: Flower Hospital/ Promedica Health System

location_facility: Orenburg Regional Clinical Oncological Center, Chemotherapy Department

location_facility: Oncology department Rabin Medical center

location_facility: "Oncological Center", Department of Haematology and Chemotherapy

location_facility: Moscow Research Oncological Institute n.a. P.A. Hertzen, Urology Departmen

location_facility: Crimea State Medical University n.a. S.I. Georgievsky, Course in Urology at the Faculty Surgery#1 Department

location_facility: Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center

location_facility: "Central Research Institute of Roentgenology & Radiology Federal Agency Healthcare Social Development"

location_facility: Zaporozhye Medical Academy of Postgraduate Education, Urology Department

location_facility: Heamatology and Oncology Associates Inc.

location_facility: Lord's Transfiguration Independent Hospital Medical Academy Poznań

location_facility: Hospital Marques de Valdecilla Consultas de Oncologia 1st planta

location_facility: Independent Public Clinical Hospital #2 - Pomeranian Medical Academy in Szczecin, Urology Clinic

location_facility: Rostov State Medical University under the Federal Agency for Healthcare and Social Development, Department of Urology

location_facility: St. Petersburg State Pediatric Medical Academy

location_facility: Regional State Medical Institution:"Orel Oncological Center", Oncology Department #5

location_facility: Ivano-Frankovsk State Medical University; Oncology Department

location_facility: Municipal Hospital #26, Department Of Urology

location_facility: Lugansk Regional Clinical Oncological Center, Urology Department

location_facility: State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center,

location_facility: Municipal Medical Institution: Oncological Center, Chemotherapy Department

location_facility: State Higher Educational Institution: Siberian State Medical University, Department of Urology

location_facility: Russian State Medical University under the Federal Agency for Healthcare and Social Development, Department of Urology and Surgical Nephrology

location_facility: State Medical Institution of Yaroslavl Region

location_facility: Dnepropetrovsk State Medical Academy, Oncology, Radiodiagnostics and Radiotherapy Department

location_facility: Murmansk Regional Oncological Center, Oncology Department #5

location_facility: The Angeles Clinic and Reseach Institute

location_facility: Regional Public Institution: Krivoy Rog Oncological Center, Chemotherapy Department

location_facility: Municipal Multi-Speciality Hospital #2, Department of Urology

location_facility: Department of Biotherapy and Bone Marrow Transplantation

location_facility: Republican Oncology Center" under the Ministry of Healthcare,

location_facility: Hospital Santa Creu i Sant Pau Hospital Nuevo-Servicio de Oncologia Medica

location_facility: Urology Institute under the Ukrainian Academy of Medical Sciences, Oncourology Department

location_facility: Leningrad Regional Oncological Center, Surgical Department #3

location_facility: Independent Public Health Care Institution University Hospital in Krakow, Department of Oncology

location_facility: Donetsk Regional Antitumor Center, Urology Department

location_facility: Crimean Republican Clinical Oncological Center, Chemotherapy Department

location_facility: Sibiu Clinical County Hospital - Urology Clinic

location_facility: Samara Regional Oncology Center, Chemotherapy Department

location_facility: Bukovyna State Medical University, Department of Oncology, Radiodiagnostics and Radiotherapy

location_facility: Military Institute of Medicine, Department of Oncology

location_facility: Non-State Medical Institution:Central Clinical Hospital

location_facility: Haematology and Oncology Associates at Bridgeport

location_facility: Hospital Severo Ochoa, Servicio de Oncologia - Primera planta

location_facility: Kharkov Regional Clinical Urology and Nephrology Center, Oncourology Department

location_facility: Medical Radiological Research Center under the Russian Academy of Medical Sciences, Department of Urology

location_facility: Oncology institute , The Chaim Sheba Medical center

location_facility: Charleston Hematology and Oncology Associates,

location_facility: State Institution of Mariy El Republic: "Republican Clinical Hospital", Department Of Urology

location_facility: Bashkir State Medical University, Urology Department

location_facility: Pyatigorsk Branch of Stavropol Territorial Clinical Oncological Center (State Medical Institution), Outpatient Department

location_facility: State Institution of Nizhny Novgorod Region: "Nizhny Novgorod Oncology Center", Department of Oncology #5 (for chemotherapy treatment)

location_facility: Urology Institute under the Ukrainian Academy of Medical Sciences, Plastic and Reconstructive Urology Department

location_facility: Fundeni Clinical Institute - Urology Department

location_facility: Oncology institute , Rambam /health Care Campus

location_facility: Regional Research Clinical Institute n.a M.F. Vladimirskiy, Urology Department #1

location_facility: State Medical Institution: Stavropol Territorial Clinical Oncological Center, Department of Urology

location_facility: St Luke's Cancer Centre, Royal Surrey County Hospital

location_facility: Universitätsklinikum C.G. Carus TU Dresden

location_facility: Russian Research Center of Roentgenology & Radiology , Surgery Department

location_facility: Zaporozhye Medical Academy of Postgraduate Education, Oncology Department

location_facility: Regional Specialistic Hospital in Wrocław, Department of Urology

location_facility: Oncology department, Assaf Harofeh Medical Center

location_facility: State Institution: Russian Oncological Research Center n.a. N.N. Blokhin of the Russian Academy of Medical Sciences, Department of Urology

location_facility: State Medical Institution: Tambov Regional Oncological Center, Surgery Department

location_facility: Henry Ford Health System / Josephine Ford Cancer Center

intervention_type: Biological


title: Study of the Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection

summary: The purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic liver transplant (OLT) due to HBV infection.

design_allocation: Non-Randomized

lead_sponsor: Bristol-Myers Squibb

location_country:
Taiwan
Brazil
Spain
Italy
Australia
Argentina
Korea, Republic of
United States
France

location_facility:
Mayo Clinic
Cleveland Clinic
University Of Cincinnati Medical Center
University Of Nebraska Medical Center
Baylor University Medical Center
Baylor College Of Medicine
University Of Rochester Medical Center
Tulane University Hospital & Clinic
Northwestern University
Local Institution


title: A Multicenter, Randomized Double-Blind Phase II/III Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma (TCC) of the Urothelium Comparing Vinflunine/Gemcitabine to Placebo/Gemcitabine in Patients Who Are Ineligible to Receive Cisplatin-Based Therapy

summary: The purpose of this study is to test an investigational drug, vinflunine (BMS-710485), in combination with gemcitabine in patients with Transitional Cell Carcinoma who cannot be treated with cisplatin. This study will help to determine whether vinflunine in combination with gemcitabine will extend the time period until further growth of the tumor more than gemcitabine alone.

location_country:
Denmark
Poland
Spain
Greece
Italy
Australia
Russian Federation
Canada
Thailand
Indonesia
United Kingdom
Korea, Republic of
United States
France
Belgium
Philippines

location_facility: Hematology Oncology Centers Of The Northern Rockies, Pc

location_facility: Carolinas Hematology Oncology Associates

location_facility: The Cancer Center At Hackensack University Medical Center

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

location_facility: Washington University School Of Medicine

location_facility: Kansas City Veterans Affairs Medical Center

location_facility: Univ. Of Washington Medical Ctr., Prostate-Oncology Ctr

location_facility: The Center For Cancer And Blood Disorders

location_facility: North Valley Hematology/Oncology Medical Group

location_facility: South Texas Oncology And Hematology, P.A.

location_facility: University Of Florida College Of Medicine At Jacksonville

location_facility: University Of Missouri Healthcare/Ellis Fischel Cancer Ctr

location_facility: Acrc/Arizona Clinical Research Center, Inc.

location_facility: Capital Comprehensive Cancer Care Center

location_facility: Guthrie Foundation For Education And Research

location_facility: University Of Texas Medical Branch Of Galveston

location_facility: Glendale Memorial Hospital And Health Center

intervention_type: Other


title: A Randomized, Open-label Multicentre Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to Tobramycin Solution for Inhalation in Cystic Fibrosis Subjects

acronym: EAGER

summary: This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
Australia
Mexico
Canada
Netherlands
Hungary
United States
Chile
France
Israel
Colombia
Germany

location_facility: West Virginia University Health Sciences Center


title: Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer

summary: The purpose of this study is to learn if men with metastatic prostate cancer and rising Prostate Specific Antigen (PSA), who have been surgically castrated or are undergoing androgen deprivation with Luteinizing Hormone Releasing Hormone (LHRH) treatment, respond to dasatinib. The safety of this treatment will also be studied.

ReferenceType: background

ReferenceCitation: Yu EY, Wilding G, Posadas E, Gross M, Culine S, Massard C, Morris MJ, Hudes G, Calabrò F, Cheng S, Trudel GC, Paliwal P, Sternberg CN. Phase II study of dasatinib in patients with metastatic castration-resistant prostate cancer. Clin Cancer Res. 2009 Dec 1;15(23):7421-8. doi: 10.1158/1078-0432.CCR-09-1691. Epub 2009 Nov 17.

location_country:
United States
Italy
France

location_facility: Memorial Sloan-Kettering Cancer Center-Sidney Kimmel Center

location_facility: University Of Wisconsin Paul P Carbone Comprehensive Ca Ctr

location_facility: The Bunting Blaustein Cancer Research Building


type: Other Identifier

title: The Comparison of the Efficacy and Safety of Arzoxifene Versus Raloxifene in Postmenopausal Women With Osteoporosis

summary: The purpose of this study is to compare the effect of arzoxifene to raloxifene on the bone mineral density (bone strength).

lead_sponsor: Eli Lilly and Company

location_country:
Taiwan
Spain
Italy
Australia
Argentina
Canada
United States
France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: An Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study of E2007 (Perampanel) as an Adjunctive Therapy in Patients With Refractory Partial Seizures

lead_sponsor: Eisai Inc.

source: euctr

ReferenceType: derived

ReferenceCitation: Maguire M. Response to "Perampanel and pregnancy: Could experience be a gloomy lantern that does not even illuminate its bearer?" Epilepsy Behav. 2022 Apr;129:108654. doi: 10.1016/j.yebeh.2022.108654. Epub 2022 Mar 16.

ReferenceCitation: Rektor I, Krauss GL, Bar M, Biton V, Klapper JA, Vaiciene-Magistris N, Kuba R, Squillacote D, Gee M, Kumar D. Perampanel Study 207: long-term open-label evaluation in patients with epilepsy. Acta Neurol Scand. 2012 Oct;126(4):263-9. doi: 10.1111/ane.12001. Epub 2012 Aug 23.

location_country:
Spain
Latvia
United Kingdom
Estonia
Australia
Finland
Czech Republic
Lithuania
Netherlands
Sweden
United States
France
Belgium
Germany

summary: The purpose of this study is to determine the safety of perampanel given as adjunctive, long-term treatment in patients with refractory partial onset seizures.


acronym: ULD trial

title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment for 12 Weeks in Adolescent and Adult Patients (≥ 16 Years) With Genetically Ascertained Unverricht-Lundborg Disease

lead_sponsor: UCB Pharma

type: EudraCT Number

ReferenceCitation: Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.

ReferenceCitation: Kälviäinen R, Genton P, Andermann E, Andermann F, Magaudda A, Frucht SJ, Schlit AF, Gerard D, de la Loge C, von Rosenstiel P. Brivaracetam in Unverricht-Lundborg disease (EPM1): Results from two randomized, double-blind, placebo-controlled studies. Epilepsia. 2016 Feb;57(2):210-21. doi: 10.1111/epi.13275. Epub 2015 Dec 15.

location_country:
Serbia
Russian Federation
Finland
Canada
Tunisia
United States
Israel
France

summary: The study will compare the efficacy and safety of Brivaracetam with placebo in patients with Unverricht- Lundborg Disease (ULD).


title: A 52-Week Multicenter, Open-Label, Randomized, Parallel, Two - Arm Study Comparing Exubera® (Inhaled Human Insulin) Vs. Humalog® (Insulin Lispro), Both In Combination With Insulin Glargine In Subjects With Type 1 Diabetes Mellitus

summary: To compare efficacy and safety of Exubera® vs Humalog in patients with type 1 diabetes mellitus

status: Terminated

lead_sponsor: Pfizer

location_country:
Denmark
Portugal
Spain
Ireland
Austria
United Kingdom
Finland
Sweden
United States
France
Belgium
Norway
Netherlands

status_simplified: Unknown


title: An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

summary: To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy.

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: PDL BioPharma, Inc.

location_country:
Ireland
Austria
Australia
Italy
Canada
Czech Republic
Netherlands
Ukraine
Hungary
United States
France
Belgium
Norway
Germany


title: A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Effects of Morning Administration of GW679769 (10mg and 30 mg) on Polysomnograph Sleep Recordings, Subjective Sleep Assessment, Daytime Cognition and Psychomotor Function in Subjects With Primary Insomnia

summary: This study is designed to determine whether morning doses of GW679769, taken daily for 1 to 9 days, will promote sleep during the following night without significant post-dose thinking impairment and drowsiness in subjects with primary insomnia.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
United States
France


title: DORADO-EX - A Dose-Blinded, Long-Term Safety Extension Study of Fixed Doses of Darusentan in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311-E)

acronym: Darusentan

summary: This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the United States (U.S.) Food and Drug Administration (FDA) for use in the U.S., which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan in subjects with resistant systolic hypertension despite treatment with full doses of three or more antihypertensive medications, including a diuretic.

lead_sponsor: Gilead Sciences

location_country:
Denmark
Brazil
United Kingdom
Argentina
Canada
United States
France
Sweden

location_facility: Hôpital Civil, Service HTA maladies vasculaires

location_facility: Centro Integrado Hospital do Rim e Hipertensao

location_facility: Cardiovascular Research, Karolinska Institue

location_facility: Northeast Clinical Research Centers, Inc.

location_facility: Green and Seidner Family Practice Associates

location_facility: Clinical Investigation Specialists, Inc.

location_facility: Castlerock Clinical Research Consultants

location_facility: MedStar Diabetes Institute at Washington Hospital Center


acronym: EXTEND

title: EXTEND (Eltrombopag Extended Dosing Study): An Extension Study of Eltrombopag Olamine (SB-497115-GR) in Adults, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study.

ReferenceCitation: Wong RSM, Saleh MN, Khelif A, Salama A, Portella MSO, Burgess P, Bussel JB. Safety and efficacy of long-term treatment of chronic/persistent ITP with eltrombopag: final results of the EXTEND study. Blood. 2017 Dec 7;130(23):2527-2536. doi: 10.1182/blood-2017-04-748707. Epub 2017 Oct 17. Erratum in: Blood. 2018 Feb 8;131(6):709.

ReferenceCitation: Tarantino MD, Fogarty P, Mayer B, Vasey SY, Brainsky A. Efficacy of eltrombopag in management of bleeding symptoms associated with chronic immune thrombocytopenia. Blood Coagul Fibrinolysis. 2013 Apr;24(3):284-96. doi: 10.1097/MBC.0b013e32835fac99.

ReferenceCitation: Saleh MN, Bussel JB, Cheng G, Meyer O, Bailey CK, Arning M, Brainsky A; EXTEND Study Group. Safety and efficacy of eltrombopag for treatment of chronic immune thrombocytopenia: results of the long-term, open-label EXTEND study. Blood. 2013 Jan 17;121(3):537-45. doi: 10.1182/blood-2012-04-425512. Epub 2012 Nov 20.

ReferenceCitation: Fogarty PF, Tarantino MD, Brainsky A, Signorovitch J, Grotzinger KM. Selective validation of the WHO Bleeding Scale in patients with chronic immune thrombocytopenia. Curr Med Res Opin. 2012 Jan;28(1):79-87. doi: 10.1185/03007995.2011.644849. Epub 2011 Dec 20.

ReferenceCitation: Signorovitch J, Brainsky A, Grotzinger KM. Validation of the FACIT-fatigue subscale, selected items from FACT-thrombocytopenia, and the SF-36v2 in patients with chronic immune thrombocytopenia. Qual Life Res. 2011 Dec;20(10):1737-44. doi: 10.1007/s11136-011-9912-9. Epub 2011 May 1.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Romania
Poland
Hong Kong
Slovenia
Austria
Australia
Russian Federation
Tunisia
Sweden
Slovakia
Canada
China
Germany
Denmark
Taiwan
Greece
New Zealand
Finland
Czech Republic
Thailand
Vietnam
Korea, Republic of
France
Netherlands
Pakistan

location_facility:
Novartis Investigative Site
Novartis investigative Site

summary: An open-label, dose-adjustment, extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. This study will allow adjustment of the eltrombopag dose to achieve an individualized dose and schedule for each subject. In addition, the ability to reduce the dose of concomitant ITP medications in the presence of eltrombopag, while maintaining platelet counts = 50,000/μL will be investigated.


title: A Multicenter, Open-Label, Parallel-Group, Randomized, Flexible Dose Study To Evaluate the Safety and Tolerability of Switching From Existing Atypical Antipsychotics to Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder

summary: The study will evaluate the safety and tolerability of switching subjects with schizophrenia or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.

lead_sponsor: Solvay Pharmaceuticals

location_country:
Latvia
Estonia
Argentina
Czech Republic
Canada
Lithuania
Hungary
United States
France

location_facility:
Site 197
Site 206
Site 189
Site 115
Site 104
Site 193
Site 131
Site 185
Site 232
Site 231
Site 218
Site 205
Site 156
Site 302
Site 190
Site 101
Site 116
Site 233
Site 204
Site 178
Site 175
Site 211
Site 202
Site 228
Site 164
Site 191
Site 236
Site 126
Site 109
Site 129
Site 134
Site 304
Site 183
Site 169
Site 124
Site 136
Site 194
Site 112
Site 182
Site 166
Site 145
Site 226
Site 222
Site 179
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Site 106
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Site 195
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Site 162
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Site 308
Site 207
Site 225
Site 152
Site 154
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Site 220
Site 305
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Site 142
Site 173
Site 177


title: A Phase II, Multi-centre, Open-Label, Parallel Group, Randomised Study To Compare the Efficacy of AZD6244 vs Temozolomide in Patients With Unresectable AJCC Stage 3 or 4 Malignant Melanoma

lead_sponsor: AstraZeneca

location_country:
Denmark
Brazil
United Kingdom
Austria
Australia
Argentina
Canada
Switzerland
United States
France

summary: The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with temozolomide in patients with advanced melanoma


title: A Phase III Open Label, Randomized Two-Parallel-Arm Multicenter Study of E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes

study_start_date_type: Actual

ReferenceCitation: Twelves C, Awada A, Cortes J, Yelle L, Velikova G, Olivo MS, Song J, Dutcus CE, Kaufman PA. Subgroup Analyses from a Phase 3, Open-Label, Randomized Study of Eribulin Mesylate Versus Capecitabine in Pretreated Patients with Advanced or Metastatic Breast Cancer. Breast Cancer (Auckl). 2016 Jun 28;10:77-84. doi: 10.4137/BCBCR.S39615. eCollection 2016.

ReferenceCitation: Cortes J, Hudgens S, Twelves C, Perez EA, Awada A, Yelle L, McCutcheon S, Kaufman PA, Forsythe A, Velikova G. Health-related quality of life in patients with locally advanced or metastatic breast cancer treated with eribulin mesylate or capecitabine in an open-label randomized phase 3 trial. Breast Cancer Res Treat. 2015 Dec;154(3):509-20. doi: 10.1007/s10549-015-3633-7. Epub 2015 Nov 14.

ReferenceCitation: Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, Olivo MS, He Y, Dutcus CE, Cortes J. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2015 Feb 20;33(6):594-601. doi: 10.1200/JCO.2013.52.4892. Epub 2015 Jan 20.

ReferenceCitation: Twelves C, Cortes J, Kaufman PA, Yelle L, Awada A, Binder TA, Olivo M, Song J, O'Shaughnessy JA, Jove M, Perez EA. "New" metastases are associated with a poorer prognosis than growth of pre-existing metastases in patients with metastatic breast cancer treated with chemotherapy. Breast Cancer Res. 2015 Dec 9;17(1):150. doi: 10.1186/s13058-015-0657-1.

ReferenceCitation: Twelves C, Cortes J, Vahdat LT, Wanders J, Akerele C, Kaufman PA. Phase III trials of eribulin mesylate (E7389) in extensively pretreated patients with locally recurrent or metastatic breast cancer. Clin Breast Cancer. 2010 Apr;10(2):160-3. doi: 10.3816/CBC.2010.n.023.

location_country:
Spain
Italy
Ukraine
United States
Romania
Belgium
South Africa
Czechia
Poland
Russian Federation
Australia
Argentina
Israel
Mexico
Singapore
Brazil
Canada
Hungary
Germany
Bulgaria
Taiwan
Greece
France

location_facility: Grupo Paulista de Oncologia Integrada Ltda

location_facility: Instituto Argentino de Diagnostico y Tratamiento

location_facility: Servico de Quimioterapia de Pernambuco-SEQUIPE

location_facility: Hospital do Cancer de Sao Paulo-AC Camargo

location_facility: Pecsi Tudomanyegyetem, Onkoterapias Intezet

location_facility: Hospital General de Agudos Teodoro Alvarez

location_facility: Centre Hospitalier Universitaire de Montreal, Hopital Notre Dame

location_facility: Centre Hosptialier Universitaire Sart Tilman Liege

location_facility: Hospital do Cancer de Sao Paulo-AC. Camargo

location_facility: Instituto Ribeiraopretano de Combate ao Cancer

location_facility: Liverpool Hospital, Cancer Therapy Centre

location_facility: Centre Hospitalier La Roche sur Yon, CHD les Oudairies

location_facility: CHU de Poitiers, Service d'Oncologie Medicale

location_facility: Hospital de Clinicas de Porto Alegre, Servicio de Oncologia

location_facility: Augusta-Kranken-Anstalt, Klinik fur Hamatologie und Onkologie

location_facility: Bankstown Hospital, Oncology Trials Unit

location_facility: Hospital das Clinicas de Faculdade de Medicina da Universidade de Sao

location_facility: Thunder Bay Regional Health Science Centre Northwestern Ontario

location_facility: Instituto Brasileiro de Controle do Cancer-IBCC

location_facility: Institut Jules Bordet, Medical Oncology Unit

location_facility: Sir Charles Gairdner Hospital, Dept. of Medical Oncology

summary: The purpose of this study is to compare E7389 versus capecitabine in patients with locally advanced or metastatic breast cancer who are refractory to the most recent chemotherapy. This is an open-label, randomized, two-parallel arm study. Patients will be randomized to receive either E7389 or capecitabine on a one-to-one ratio.


title: A Multicenter, Randomized, Double Blind, Parallel-Group Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease.

summary: This is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 as monotherapy in patients with early stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.

ReferenceCitation: Sampaio C, Bronzova J, Hauser RA, Lang AE, Rascol O, van de Witte SV, Theeuwes AA; Rembrandt/Vermeer Study Groups. Pardoprunox in early Parkinson's disease: results from 2 large, randomized double-blind trials. Mov Disord. 2011 Jul;26(8):1464-76. doi: 10.1002/mds.23590. Epub 2011 May 3.

location_country:
Poland
Taiwan
Portugal
Spain
Italy
United Kingdom
Estonia
Australia
Lithuania
Czech Republic
Netherlands
Thailand
United States
France
India
Malaysia
South Africa
Germany


title: A Phase II Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Alemtuzumab (CAMPATH®, MabCampath®) in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia

summary: This is a Phase II, open-label, prospective, multicenter study to evaluate the efficacy and safety of subcutaneously administered alemtuzumab (CAMPATH, MabCampath) as therapy for patients with relapsed or refractory B-CLL who have been previously treated.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Serbia
United Kingdom
Czech Republic
France
United States
Belgium

location_facility: University of Colorado Cancer Center at University of Colorado Health Sciences Center

location_facility: North Mississippi Hematology & Oncology Associates, Ltd.

location_facility: University Hospital Hradec Kralove (UH HK)

location_facility: Institute of Hematology, Clinical Centre of Serbia

location_facility: Royal Liverpool and Broadgreen Hospitals

location_facility: Hopital Hotel-Dieu, CHU de Nantes-Service d'Hematologie Clinique

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Clinic of Hematology, Clinical Centre Vojvodina Novi Sad


title: A Multinational, Multicentre, Randomized, Double-blind Study To Assess The Efficacy And Safety Of Oral Sildenafil 20mg Tid Or Placebo When Added To Bosentan In The Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension (Pah)

summary: To assess the efficacy and safety of sildenafil when added to patients with PAH who are taking bosentan as all or part of their background therapy.

ReferenceCitation: Vizza CD, Jansa P, Teal S, Dombi T, Zhou D. Sildenafil dosed concomitantly with bosentan for adult pulmonary arterial hypertension in a randomized controlled trial. BMC Cardiovasc Disord. 2017 Sep 6;17(1):239. doi: 10.1186/s12872-017-0674-3.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Taiwan
United Kingdom
Greece
Italy
Australia
United States
France
Israel
Germany
Czechia

location_facility: Department of Surgery, National Taiwan University Hospital

location_facility: Universitaetsklinikum des Saarlandes, Innere Medizin V

location_facility: Institut klinicke a experimentalni mediciny, Klinika kardiologie

location_facility: Medizinische Klinik und Poliklinik I, Universitaetsklinikum Leipzig

location_facility: II. Medizinische Klinik, Kardiologie, Angiologie und Pneumologie

location_facility: Med. Klinik u. Poliklinik I der LMU Muenchen, Klinikum Grosshadern

location_facility: Missionsaerztliche Klinik Wuerzburg, Gemeinnuetzige Gesellschaft mbH

location_facility: Praxis fuer Innere Medizin, Kardiologie und Angiologie

location_facility: West Los Angeles VA Healthcare, Pulmonary Hypertension Program

location_facility: Unfallkrankenhaus Berlin, Klinik fuer Innere Medizin

location_facility: Cardiologia, Azienda Ospedaliera Monaldi, Seconda Università di Napoli

location_facility: Universitaetsklinikum Giessen und Marburg GmbH, Standort Giessen

location_facility: Universitaetsklinikum Essen, Zentrum fuer Innere Medizin, Klinik fuer Kardiologie

location_facility: Unita' di Ipertensione Polmonare, Dipartimento di Scienze Respiratorie e Cardiovascolari


title: A Double Blind Parallel Group Randomised Multiple Dose Study To Evaluate The Pharmacodynamic Response And Safety Of PHA-794428 In Adult Growth Hormone Deficient Patients

summary: The purpose of this study is to explore the safety, toleration and dose response of PHA-794428 after multiple weekly injections in male and female growth hormone deficient patients.

ReferenceCitation: Touraine P, D'Souza GA, Kourides I, Abs R, Barclay P, Xie R, Pico A, Torres-Vela E, Ekman B; GH Lipoatrophy Study Group. Lipoatrophy in GH deficient patients treated with a long-acting pegylated GH. Eur J Endocrinol. 2009 Oct;161(4):533-40. doi: 10.1530/EJE-09-0422. Epub 2009 Aug 4.

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Netherlands
Czech Republic
Sweden
France
Belgium
Germany
Slovakia


title: A Phase 1/2 Study Of Cmc-544 Administered In Combination With Rituximab In Subjects With Follicular Or Diffuse Large B-cell Non-hodgkin's Lymphoma

summary: The purpose of the study is to determine the tolerability, the initial safety profile and maximum tolerated dose, and to obtain preliminary information on the antitumor activity of inotuzumab ozogamicin [CMC-544] in combination with rituximab in subjects with follicular, diffuse large B-Cell, or mantle cell NHL.

ReferenceCitation: Fayad L, Offner F, Smith MR, Verhoef G, Johnson P, Kaufman JL, Rohatiner A, Advani A, Foran J, Hess G, Coiffier B, Czuczman M, Giné E, Durrant S, Kneissl M, Luu KT, Hua SY, Boni J, Vandendries E, Dang NH. Safety and clinical activity of a combination therapy comprising two antibody-based targeting agents for the treatment of non-Hodgkin lymphoma: results of a phase I/II study evaluating the immunoconjugate inotuzumab ozogamicin with rituximab. J Clin Oncol. 2013 Feb 10;31(5):573-83. doi: 10.1200/JCO.2012.42.7211. Epub 2013 Jan 7.

location_country:
Poland
Hong Kong
Spain
Italy
United Kingdom
Australia
Netherlands
Switzerland
Korea, Republic of
United States
France
Belgium
Germany

location_facility: University Hospital Gent - Department of Hematology

location_facility: The University of Texas M.D. Anderson Cancer Center

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet, III. medizinische klinik und Poliklinik

location_facility: Universitaetsklinik Bonn, Medizinische Klinik und Poliklinik III

location_facility: Emory University Investigational Drug Service

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Bart's Cancer Institute; Queen Mary University of London

location_facility: Universita La Sapienza Cattedra di Ematologia


title: A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease

summary: The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.

ReferenceCitation: Rigotti NA, Pipe AL, Benowitz NL, Arteaga C, Garza D, Tonstad S. Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial. Circulation. 2010 Jan 19;121(2):221-9. doi: 10.1161/CIRCULATIONAHA.109.869008. Epub 2010 Jan 4.

location_country:
Denmark
Taiwan
Brazil
United Kingdom
Greece
Australia
Netherlands
Argentina
Canada
Czech Republic
Korea, Republic of
United States
France
Mexico
Germany


title: A Randomized, Comparative, Double-Blind, Parallel-Group, Multicenter, Monotherapy, Study Of Pregabalin (Lyrica) And Lamotrigine (Lamictal) In Patients With Newly Diagnosed Partial Seizures

summary: The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.

ReferenceCitation: Kwan P, Brodie MJ, Kälviäinen R, Yurkewicz L, Weaver J, Knapp LE. Efficacy and safety of pregabalin versus lamotrigine in patients with newly diagnosed partial seizures: a phase 3, double-blind, randomised, parallel-group trial. Lancet Neurol. 2011 Oct;10(10):881-90. doi: 10.1016/S1474-4422(11)70154-5. Epub 2011 Aug 31.

location_country:
Spain
Italy
United Kingdom
Lithuania
Belgium
Romania
Czechia
Hong Kong
Portugal
India
Mexico
Norway
Singapore
Sweden
Slovakia
Hungary
China
Germany
Bulgaria
Taiwan
Ireland
Latvia
Estonia
Finland
Thailand
Korea, Republic of
France
Colombia
Netherlands


title: A Randomized, Double-blind, Multicenter Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study

summary: The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.

lead_sponsor: Facet Biotech

location_country:
Croatia
Italy
Austria
Australia
Netherlands
Canada
Czech Republic
Ukraine
Hungary
United States
France
Israel
Belgium
Norway
Germany


title: A Randomized, Open-Label, Parallel-Group, Multicentre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Anastrozole (ARIMIDEX™) 1 mg as First Line Hormonal Treatment for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer

acronym: FIRST

summary: The purpose of this study is to compare the efficacy and tolerability of Faslodex (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor positive advanced breast cancer.

location_country:
Poland
Brazil
Spain
Italy
United Kingdom
France
United States
Bulgaria
Czechia


title: A Randomised, Double Blind, Placebo-controlled, Parallel Group Study to Investigate the Safety and Efficacy of Controlled-release Ropinirole (CR) (1-24 mg) Administered Once Daily for 12 Weeks in Subjects With Fibromyalgia

summary: A study to investigate ropinirole for treatment of the symptoms of fibromyalgia and in particular the widespread pain associated with this condition. A total 160 subjects (80 per treatment arm) are being recruited from approximately 25 centres in 9 European countries. Male and female subjects greater than 18 years of age with a diagnosis of primary fibromyalgia, as defined by the American College of Rheumatology (ACR) criteria, are eligible for study entry. Subjects will receive either ropinirole (1-24mg) or placebo, depending upon a statistically defined allocation to treatment. The primary endpoint is improvement in pain score by 12 weeks of treatment. An 11 point numerical rating scale for the assessment of the subject's pain is being collected on a daily diary. In addition, the overall improvement in quality of life for the subject will be assessed by means of a number of subject-completed questionnaires during the treatment period. Safety of the treatment regimen will be assessed throughout the study.

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country:
Denmark
United Kingdom
Italy
Netherlands
Finland
Sweden
France
Belgium
Germany


title: A Phase 2, Open Label, Single Arm Study To Evaluate The Efficacy, Safety, Tolerability And Pharmacokinetics Of CP-675,206 In Patients With Advanced Refractory And/Or Relapsed Melanoma

summary: CP-675,206 is a fully human monoclonal antibody (mAb). It binds to the CTLA4 molecule, which is expressed on the surface of activated T lymphocytes. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 is not expected to have a direct effect on tumor cells. CP-675,206 been shown to induce durable tumor responses in patients with metastatic melanoma in Phase 1 and Phase 2 clinical studies.

location_country:
Spain
Italy
United Kingdom
Australia
Argentina
Canada
United States
France
Germany

location_facility:
Research Site
Pfizer Investigational Site


title: A Phase 2 Efficacy And Safety Study Of SU011248 In Combination With Trastuzumab As Treatment For Metastatic Disease In Patients With Breast Cancer

summary: The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.

ReferenceCitation: Bachelot T, Garcia-Saenz JA, Verma S, Gutierrez M, Pivot X, Kozloff MF, Prady C, Huang X, Khosravan R, Wang Z, Cesari R, Tassell V, Kern KA, Blay JY, Lluch A. Sunitinib in combination with trastuzumab for the treatment of advanced breast cancer: activity and safety results from a phase II study. BMC Cancer. 2014 Mar 7;14:166. doi: 10.1186/1471-2407-14-166.

location_country:
Spain
Canada
United States
France
Belgium


title: A Phase III, Multicentre, Randomized, Double-blind, Parallel-group Study to Evaluate the Safety of Once Daily Esomeprazole for the Treatment of Clinically Diagnosed Gastroesophageal Reflux Disease (GERD) in Pediatric and Adolescent Patients 12 to 17 Years of Age, Inclusive.

summary: This study is a phase III, multi-centre, randomized, double-blind study to assess the safety and tolerability of once daily treatment with esomeprazole 20 or 40 mg in pediatric and adolescent patients 12 to 17 years of age, inclusive, with clinically diagnosed GERD. The treatment period will be up to 8 weeks.

ReferenceCitation: Gunasekaran T, Tolia V, Colletti RB, Gold BD, Traxler B, Illueca M, Crawley JA. Effects of esomeprazole treatment for gastroesophageal reflux disease on quality of life in 12- to 17-year-old adolescents: an international health outcomes study. BMC Gastroenterol. 2009 Nov 18;9:84. doi: 10.1186/1471-230X-9-84.

location_country:
United States
Italy
Canada
France


title: Aripiprazole (BMS-337039) for Outpatients With Schizophrenia Completing Aripiprazole Clinical Trials: A Non-Comparative Rollover Protocol

summary: The purpose of this study is to provide aripiprazole to schizophrenic outpatients and Community Treated Patients who are currently receiving aripiprazole therapy on another BMS sponsored clinical trial.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Croatia
Poland
United Kingdom
Russian Federation
Canada
Czech Republic
Hungary
France
South Africa
Romania
Netherlands


title: A Phase III, Multicentre, Randomized, Double-blind Parallel-group Study to Evaluate the Safety and Clinical Outcome of Once Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients 1 to 11 Years of Age, Inclusive.

summary:
To look at the safety and improvement in symptoms of a once a day dosing of esomeprazole in children 1 to 11 years old with inflammation of their esophagus or food pipe ("esophagitis") caused by gastroesophageal reflux disease (GERD) and diagnosed by endoscopy.

To verify the healing of the esophageal inflammation if the endoscopy reveals cuts in the lining of the food pipe.

To collect information that will describe the psychological, social, and economic effects on the primary caregiver of raising children ages 1 to 5 years old with GERD.

ReferenceCitation: Tolia V, Gilger MA, Barker PN, Illueca M. Healing of Erosive Esophagitis and Improvement of Symptoms of Gastroesophageal Reflux Disease After Esomeprazole Treatment in Children 12 to 36 Months Old. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S31-6. doi: 10.1097/MPG.0b013e3181ddcf11.

ReferenceCitation: Tolia V, Youssef NN, Gilger MA, Traxler B, Illueca M. Esomeprazole for the Treatment of Erosive Esophagitis in Children: An International, Multicenter, Randomized, Parallel-Group, Double-Blind (for Dose) Study. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S24-30. doi: 10.1097/01.mpg.0000469419.29000.94.

ReferenceCitation: Tolia V, Gilger MA, Barker PN, Illueca M. Healing of erosive esophagitis and improvement of symptoms of gastroesophageal reflux disease after esomeprazole treatment in children 12 to 36 months old. J Pediatr Gastroenterol Nutr. 2010 Nov;51(5):593-8. doi: 10.1097/MPG.0b013e3181ddcf11.

ReferenceCitation: Tolia V, Youssef NN, Gilger MA, Traxler B, Illueca M. Esomeprazole for the treatment of erosive esophagitis in children: an international, multicenter, randomized, parallel-group, double-blind (for dose) study. BMC Pediatr. 2010 Jun 11;10:41. doi: 10.1186/1471-2431-10-41.

ReferenceCitation: Gilger MA, Tolia V, Vandenplas Y, Youssef NN, Traxler B, Illueca M. Safety and tolerability of esomeprazole in children with gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr. 2008 May;46(5):524-33. doi: 10.1097/MPG.0b013e318176b2cb.

location_country:
Italy
United States
France
Belgium


title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 148 Administered Subcutaneously in Symptomatic Subjects With Severe Persistent Asthma

summary: The purpose of this study is to evaluate the effectiveness and safety of CNTO 148 (golimumab) in patients with severe persistent asthma.

ReferenceCitation: Wenzel SE, Barnes PJ, Bleecker ER, Bousquet J, Busse W, Dahlén SE, Holgate ST, Meyers DA, Rabe KF, Antczak A, Baker J, Horvath I, Mark Z, Bernstein D, Kerwin E, Schlenker-Herceg R, Lo KH, Watt R, Barnathan ES, Chanez P; T03 Asthma Investigators. A randomized, double-blind, placebo-controlled study of tumor necrosis factor-alpha blockade in severe persistent asthma. Am J Respir Crit Care Med. 2009 Apr 1;179(7):549-58. doi: 10.1164/rccm.200809-1512OC. Epub 2009 Jan 8.

lead_sponsor: Centocor, Inc.

location_country:
Poland
United Kingdom
Netherlands
Czech Republic
Sweden
Hungary
France
United States
Belgium
Germany
Bulgaria


title: Fracture Incidence Reduction And Safety Of TSE-424 (Bazedoxifene Acetate) Compared To Placebo And Raloxifene In Osteoporotic Postmenopausal Women

summary: The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.

ReferenceCitation: Christiansen C, Chesnut CH 3rd, Adachi JD, Brown JP, Fernandes CE, Kung AW, Palacios S, Levine AB, Chines AA, Constantine GD. Safety of bazedoxifene in a randomized, double-blind, placebo- and active-controlled Phase 3 study of postmenopausal women with osteoporosis. BMC Musculoskelet Disord. 2010 Jun 22;11:130. doi: 10.1186/1471-2474-11-130.

location_country:
Croatia
Spain
Italy
Lithuania
United States
Belgium
Romania
South Africa
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
Mexico
Norway
Slovakia
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
Greece
Estonia
New Zealand
Finland
France
Chile
Netherlands


title: Establishment of Baseline and Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System

summary: The purpose of this non-significant risk study is to establish initial baseline infection rates for the Codman BACTISEAL External Ventricular Drainage (B-EVD) System (Antibiotic impregnated catheter) and to compare relative rates of ventriculostomy-related infection between Subjects with BACTISEAL or conventional EVD catheters in a prospective, randomized open label study

ReferenceCitation: Codman in house testing reports, TR2213 and PVER99-133 Addendum

ReferenceCitation: Bayston R. Hydrocephalus Shunt Infections. Chapman and Hall Medical, London, 1989, p. 23.

ReferenceCitation: Bayston R, Grove N, Siegel J, Lawellin D, Barsham S. Prevention of hydrocephalus shunt catheter colonisation in vitro by impregnation with antimicrobials. J Neurol Neurosurg Psychiatry. 1989 May;52(5):605-9.

ReferenceCitation: Bayston R, Lambert E. Duration of protective activity of cerebrospinal fluid shunt catheters impregnated with antimicrobial agents to prevent bacterial catheter-related infection. J Neurosurg. 1997 Aug;87(2):247-51.

ReferenceCitation: Govender ST, Nathoo N, van Dellen JR. Evaluation of an antibiotic-impregnated shunt system for the treatment of hydrocephalus. J Neurosurg. 2003 Nov;99(5):831-9.

ReferenceCitation: Lozier AP, Sciacca RR, Romagnoli MF, Connolly ES Jr. Ventriculostomy-related infections: a critical review of the literature. Neurosurgery. 2002 Jul;51(1):170-81; discussion 181-2. Review.

ReferenceCitation: Schierholz J, Jansen B, Jaenicke L, Pulverer G. In-vitro efficacy of an antibiotic releasing silicone ventricle catheter to prevent shunt infection. Biomaterials. 1994 Oct;15(12):996-1000.

ReferenceCitation: Zabramski JM, Whiting D, Darouiche RO, Horner TG, Olson J, Robertson C, Hamilton AJ. Efficacy of antimicrobial-impregnated external ventricular drain catheters: a prospective, randomized, controlled trial. J Neurosurg. 2003 Apr;98(4):725-30.

lead_sponsor: Codman & Shurtleff

location_country:
Hong Kong
United Kingdom
Canada
United States
France
China
Norway
Singapore

location_facility:
Tiantan Hospital
National Neuroscience Institute
Xuan Wu Hospital
Queen Mary Hospital
Prince of Wales Hospital
Singapore General Hospital

intervention_type: Device


title: A Multi Center, Open Label Study of the Human Anti TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease

summary: To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.

ReferenceCitation: Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.

ReferenceCitation: Schreiber S, Reinisch W, Colombel JF, Sandborn WJ, Hommes DW, Robinson AM, Huang B, Lomax KG, Pollack PF. Subgroup analysis of the placebo-controlled CHARM trial: increased remission rates through 3 years for adalimumab-treated patients with early Crohn's disease. J Crohns Colitis. 2013 Apr;7(3):213-21. doi: 10.1016/j.crohns.2012.05.015. Epub 2012 Jun 16.

ReferenceCitation: Colombel JF, Schwartz DA, Sandborn WJ, Kamm MA, D'Haens G, Rutgeerts P, Enns R, Panaccione R, Schreiber S, Li J, Kent JD, Lomax KG, Pollack PF. Adalimumab for the treatment of fistulas in patients with Crohn's disease. Gut. 2009 Jul;58(7):940-8. doi: 10.1136/gut.2008.159251. Epub 2009 Feb 6.

lead_sponsor: Abbott

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Sweden
Hungary
United States
France
South Africa
Belgium
Germany

location_facility:
Site Ref # / Investigator 1778
Site Ref # / Investigator 1779
Site Ref # / Investigator 1948
Site Ref # / Investigator 1822
Site Ref # / Investigator 1844
Site Ref # / Investigator 1924
Site Ref # / Investigator 1860
Site Ref # / Investigator 1941
Site Ref # / Investigator 1943
Site Ref # / Investigator 1883
Site Ref # / Investigator 1868
Site Ref # / Investigator 1849
Site Ref # / Investigator 1782
Site Ref # / Investigator 1909
Site Ref # / Investigator 1786
Site Ref # / Investigator 1922
Site Ref # / Investigator 1772
Site Ref # / Investigator 1850
Site Ref # / Investigator 1913
Site Ref # / Investigator 2458
Site Ref # / Investigator 1942
Site Ref # / Investigator 1897
Site Ref # / Investigator 1831
Site Ref # / Investigator 1885
Site Ref # / Investigator 1861
Site Ref # / Investigator 1949
Site Ref # / Investigator 1906
Site Ref # / Investigator 1829
Site Ref # / Investigator 1878
Site Ref # / Investigator 2524
Site Ref # / Investigator 1825
Site Ref # / Investigator 1826
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title: A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

summary: Primary: To assess the efficacy and safety of DVS-233 SR compared with placebo for treatment of vasomotor symptoms (VMS) associated with menopause and to compare the bleeding incidence of DVS-233 SR and tibolone. Secondary: To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Croatia
Poland
Romania
Spain
United Kingdom
Mexico
Finland
Czech Republic
Ukraine
Sweden
Hungary
France
South Africa
Belgium
Netherlands


title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety, Tolerability and Efficacy of the CCR1 Antagonist ZK 811752, Given Orally in a Dose of 600 mg Three Times Daily, for the Treatment of Endometriosis Over 12 Weeks

summary: This study was designed as a proof-of-concept trial to evaluate safety, tolerability, and the efficacy of 1800 mg (ZK 811752 600 mg given orally three times daily) over 12 weeks for the treatment of endometriosis associated pelvic pain (EAPP) in comparison to placebo.

lead_sponsor: Bayer

location_country:
Denmark
Spain
Finland
Czech Republic
Sweden
France
Netherlands


title: Effect of Two Years of Treatment With Norditropin® SimpleXx® on Bone Mineral Density in Young Adults With Childhood-Onset Growth Hormone Deficiency

summary: This trial is conducted in Europe. Growth Hormone in young adults with growth hormone deficiency in childhood. This trial compares a treated group of patients with an untreated group of patients.

ReferenceCitation: Zacharin M, Szarras-Czapnik M, Racz K, Keller A, Tauber M, Conway G. Growth hormone (GH) treatment improves bone mineral density during transition of GH-deficient patients from adolescence to adulthood. European Society for Paediatric Endocrinology (ESPE) 2007; Country: Finland City: Helsinki

ReferenceCitation: Zacharin M, Keller A, Chanson P, Conway G on behalf of the 1369 GHD to GHDA. Efficacy of two years' growth hormone (GH) treatment on bone mineral density in young adults with childhood-onset GH deficiency. The Endocrine Society Annual Meeting (ENDO) 2007; Country: Canada City: Toronto

ReferenceCitation: Conway G, Scarras-Czapnik M, Racz K, Keller A, Chanson P, Kappelgaard A M, Zacharin M, Hyldstrup L. Direct X-ray radiogrammetry versus dual-energy X-ray absorptiometry: assessment of bone density in young adult with childhood-onset growth hormone deficiency treated with growth hormone. The Endocrine Society Annual Meeting (ENDO) 2008; Country: USA City: San Francisco

lead_sponsor: Novo Nordisk A/S

location_country:
Poland
Spain
United Kingdom
Austria
Australia
Switzerland
Sweden
Hungary
France
Belgium
Norway
Germany


title: A Study of the Safety and Efficacy of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

summary: The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.

ReferenceCitation: Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B, O'Keefe SJ. Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome. Gut. 2011 Jul;60(7):902-14. doi: 10.1136/gut.2010.218271. Epub 2011 Feb 11.

ReferenceCitation: O'Keefe SJ, Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B. Safety and efficacy of teduglutide after 52 weeks of treatment in patients with short bowel intestinal failure. Clin Gastroenterol Hepatol. 2013 Jul;11(7):815-23.e1-3. doi: 10.1016/j.cgh.2012.12.029. Epub 2013 Jan 17.

ReferenceCitation: Vipperla K, O'Keefe SJ. Study of teduglutide effectiveness in parenteral nutrition-dependent short-bowel syndrome subjects. Expert Rev Gastroenterol Hepatol. 2013 Nov;7(8):683-7. doi: 10.1586/17474124.2013.842894. Epub 2013 Oct 17. Review.

lead_sponsor: Shire

location_country:
Denmark
Poland
United Kingdom
Canada
United States
France
Belgium
Netherlands

location_facility: Academic Medical Center, Department of Endocrinology & Metabolism

location_facility: University of Pennsylvania - Penn Nursing

location_facility: Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP


title: An Extension to a Phase II Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia Who Are Refractory to or Intolerant of Interferon-Alpha

summary: During the Core Phase of the study, participants received STI571 at a dose of 400 milligrams (mg) daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study provided that, in the opinion of the investigator, they had benefited from treatment with STI571 and there were no safety concerns.

lead_sponsor: Novartis Pharmaceuticals

location_country:
United Kingdom
Italy
Switzerland
United States
France
Germany

location_facility: H. Lee Moffet Cancer Center & Research Institute/Univ of South Florida

location_facility: C/O V. Ward - Washington Univ. school of Medicine

location_facility: MD Anderson Cancer Center, University of Texas

location_facility: Wayne State University/Kamanos Cancer Center

location_facility: Northwestern Univ meical School/Robert H. Lurie Comprehensive Cancer Center


title: A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Clinical Efficacy of Two Different Doses of BMS-188667 Administered Intravenously to Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate

summary: This study was conducted to assess the safety and tolerability of Abatacept combined with Methotrexate in participants with active rheumatoid arthritis (RA). The secondary objectives were to assess efficacy, pharmacodynamic marker activity, and immunogenicity of Abatacept combined with Methotrexate.

ReferenceCitation: Westhovens R, Kremer JM, Emery P, Russell AS, Alten R, Barré E, Dougados M. Long-term safety and efficacy of abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: a 7-year extended study. Clin Exp Rheumatol. 2014 Jul-Aug;32(4):553-62. Epub 2014 Jul 8.

lead_sponsor: Bristol-Myers Squibb

location_country:
United Kingdom
Ireland
Australia
Netherlands
Argentina
Canada
United States
France
South Africa
Belgium
Germany


title: An Evaluation of the Effectiveness and Tolerability of Tapentadol Hydrochloride Prolonged Release, and Tapentadol Hydrochloride Immediate Release on Demand, in Subjects With Uncontrolled Severe Chronic Nociceptive, Mixed or Neuropathic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics.

lead_sponsor: Grünenthal GmbH

ReferenceCitation: Steigerwald I, Müller M, Davies A, Samper D, Sabatowski R, Baron R, Rozenberg S, Szczepanska-Szerej A, Gatti A, Kress HG. Effectiveness and safety of tapentadol prolonged release for severe, chronic low back pain with or without a neuropathic pain component: results of an open-label, phase 3b study. Curr Med Res Opin. 2012 Jun;28(6):911-36. doi: 10.1185/03007995.2012.679254. Epub 2012 May 9.

ipd_sharing_description: Information available on the Grünenthal Web Site

location_country:
Croatia
Poland
Spain
Italy
Austria
United Kingdom
Switzerland
France
Germany

location_facility:
Site 5
Site 8
Site 4
Site 2
Site 6
Site 7
Site 1
Site 3

summary:
The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back pain (LBP) who are taking either WHO Step I or Step II analgesics or no regular analgesics. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome.

The trial will compare the effectiveness of previous analgesic treatment (either WHO Step I or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride prolonged release (PR) treatment during defined periods of evaluation.


acronym: BOOST™

title: NN5401-3594: A 26-week, Open-labelled, Two-arm, Parallel, Randomised Trial Comparing Efficacy and Safety of NN5401 Once Daily Plus Insulin Aspart vs. Basal-bolus Treatment With Insulin Detemir Plus Insulin Aspart in Subjects With Type 1 Diabetes / NN5401-3645: An Extension Trial Comparing Safety and Efficacy of NN5401 Plus Meal-time Insulin Aspart for the Remaining Meals With Insulin Detemir Plus Meal-time Insulin Aspart in Type 1 Diabetes (BOOST™: T1)

ReferenceCitation: Hirsch IB, Franek E, Mersebach H, Bardtrum L, Hermansen K. Safety and efficacy of insulin degludec/insulin aspart with bolus mealtime insulin aspart compared with standard basal-bolus treatment in people with Type 1 diabetes: 1-year results from a randomized clinical trial (BOOST(®) T1). Diabet Med. 2017 Feb;34(2):167-173. doi: 10.1111/dme.13068. Epub 2016 Feb 19.

ReferenceCitation: Hirsch IB, Bode B, Courreges JP, Dykiel P, Franek E, Hermansen K, King A, Mersebach H, Davies M. Insulin degludec/insulin aspart administered once daily at any meal, with insulin aspart at other meals versus a standard basal-bolus regimen in patients with type 1 diabetes: a 26-week, phase 3, randomized, open-label, treat-to-target trial. Diabetes Care. 2012 Nov;35(11):2174-81. doi: 10.2337/dc11-2503. Epub 2012 Aug 28.

location_country:
Denmark
Poland
United Kingdom
Russian Federation
Australia
Puerto Rico
United States
France
Israel
Romania

summary:
This trial is conducted in Europe, Oceania, and the United States of America (USA).

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart.

The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.


title: A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Subjects With Congenital Factor XIII Deficiency

type: Registry Identifier

ReferenceCitation: Brand-Staufer B, Carcao M, Kerlin BA, Will A, Williams M, Tornøe CW, Sandberg Lundblad M, Nugent D. Pharmacokinetic characterization of recombinant factor XIII (FXIII)-A2 across age groups in patients with FXIII A-subunit congenital deficiency. Haemophilia. 2015 May;21(3):380-385. doi: 10.1111/hae.12616. Epub 2015 Jan 21.

ReferenceCitation: Kerlin B, Brand B, Inbal A, Halimeh S, Nugent D, Lundblad M, Tehranchi R. Pharmacokinetics of recombinant factor XIII at steady state in patients with congenital factor XIII A-subunit deficiency. J Thromb Haemost. 2014 Dec;12(12):2038-43. doi: 10.1111/jth.12739. Epub 2014 Oct 25.

location_country:
Spain
Italy
Austria
United Kingdom
Finland
Canada
Switzerland
United States
France
Israel
Japan
Germany

summary: This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the safety of monthly replacement therapy of recombinant factor XIII in patients with congenital FXIII deficiency. The trial continues until the product is commercially available, but an interim assessment will take place when all subjects have completed 52 weeks in the trial.


title: A Randomized, Partially-blind Study on the Safety, Tolerability and Effect on Virological Response of Treatment With the HCV Protease Inhibitor RO5190591 in Combination With Pegasys and Copegus, Versus Pegasys and Copegus Alone, in Treatment-Naïve Patients With Hepatitis C Genotype 1 Virus Infectio

summary: This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.

ReferenceCitation: Marcellin P, Cooper C, Balart L, Larrey D, Box T, Yoshida E, Lawitz E, Buggisch P, Ferenci P, Weltman M, Labriola-Tompkins E, Le Pogam S, Nájera I, Thomas D, Hooper G, Shulman NS, Zhang Y, Navarro MT, Lim CY, Brunda M, Terrault NA, Yetzer ES. Randomized controlled trial of danoprevir plus peginterferon alfa-2a and ribavirin in treatment-naïve patients with hepatitis C virus genotype 1 infection. Gastroenterology. 2013 Oct;145(4):790-800.e3. doi: 10.1053/j.gastro.2013.06.051. Epub 2013 Jun 26.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Austria
Australia
Canada
United States
France
Germany


title: A Multi-center, Open Label Phase II Trial of TKI258 in FGFR1 Amplified and Non-amplified Metastatic or Advanced HER2 Negative Breast Cancer

location_country:
Taiwan
Spain
Italy
United Kingdom
Finland
Canada
United States
France

location_facility: Texas Oncology, P.A. Dept. of Texas Oncology

location_facility: UCLA/ University of California Los Angeles Div. of Hematology/Oncology

location_facility: Northwest Cancer Specialists Northwest Office (2)

location_facility: Florida Cancer Specialists Dept.of FloridaCancerSpec. (2)

location_facility: Texas Oncology, P.A. Texas Oncology - Sammons

location_facility: Tyler Cancer Center Dept.ofTylerCancerCtr. (2)

location_facility: Comprehensive Blood and Cancer Center Dept CBCC (3)

location_facility: Fairfax Northern Virginia Hematology Oncology Fairfax NVH

location_facility: UNC/ Lineberger Comprehensive Cancer Center Dept. of Linberger Cancer Ctr

location_facility: Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care

location_facility: Central Coast Medical Oncology Corporation

location_facility: Cancer Care Associates Medical Group Dept. of CCA

location_facility: Texas Oncology, P.A. Presbyterian Hospital

summary: The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 3 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status.


title: A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Axial Spondyloarthritis

lead_sponsor: AbbVie (prior sponsor, Abbott)

ReferenceCitation: van der Heijde D, Sieper J, Maksymowych WP, Lambert RG, Chen S, Hojnik M, Anderson JK, Pangan AL. Clinical and MRI remission in patients with nonradiographic axial spondyloarthritis who received long-term open-label adalimumab treatment: 3-year results of the ABILITY-1 trial. Arthritis Res Ther. 2018 Mar 27;20(1):61. doi: 10.1186/s13075-018-1556-5.

ReferenceCitation: van der Heijde D, Sieper J, Maksymowych WP, Brown MA, Lambert RG, Rathmann SS, Pangan AL. Spinal inflammation in the absence of sacroiliac joint inflammation on magnetic resonance imaging in patients with active nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2014 Mar;66(3):667-73. doi: 10.1002/art.38283.

ReferenceCitation: Sieper J, van der Heijde D, Dougados M, Mease PJ, Maksymowych WP, Brown MA, Arora V, Pangan AL. Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: results of a randomised placebo-controlled trial (ABILITY-1). Ann Rheum Dis. 2013 Jun;72(6):815-22. doi: 10.1136/annrheumdis-2012-201766. Epub 2012 Jul 7.

location_country:
Spain
United Kingdom
Australia
Netherlands
Canada
Czech Republic
United States
France
Belgium
Germany

location_facility:
Site Reference ID/Investigator# 21285
Site Reference ID/Investigator# 26882
Site Reference ID/Investigator# 22343
Site Reference ID/Investigator# 21267
Site Reference ID/Investigator# 21282
Site Reference ID/Investigator# 21226
Site Reference ID/Investigator# 21231
Site Reference ID/Investigator# 21223
Site Reference ID/Investigator# 21263
Site Reference ID/Investigator# 21261
Site Reference ID/Investigator# 26582
Site Reference ID/Investigator# 21265
Site Reference ID/Investigator# 21247
Site Reference ID/Investigator# 21222
Site Reference ID/Investigator# 21225
Site Reference ID/Investigator# 21250
Site Reference ID/Investigator# 26883
Site Reference ID/Investigator# 21245
Site Reference ID/Investigator# 21266
Site Reference ID/Investigator# 21289
Site Reference ID/Investigator# 21230
Site Reference ID/Investigator# 21283
Site Reference ID/Investigator# 21241
Site Reference ID/Investigator# 21229
Site Reference ID/Investigator# 21264
Site Reference ID/Investigator# 21227
Site Reference ID/Investigator# 21249
Site Reference ID/Investigator# 21228
Site Reference ID/Investigator# 27382
Site Reference ID/Investigator# 21248
Site Reference ID/Investigator# 21243
Site Reference ID/Investigator# 21246
Site Reference ID/Investigator# 22342
Site Reference ID/Investigator# 21284
Site Reference ID/Investigator# 21262
Site Reference ID/Investigator# 21224
Site Reference ID/Investigator# 21281
Site Reference ID/Investigator# 26544

summary: This study will evaluate how well adalimumab works in the short and long term in patients with axial spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or psoriatic arthritis.


title: A Randomized, Sham-Injection Controlled, Double-Masked, Multicenter Trial of Ocriplasmin Intravitreal Injection for Treatment of Focal Vitreomacular Adhesion in Subjects With Exudative Age-Related Macular Degeneration (AMD)

summary: This study will evaluate the safety and efficacy of Ocriplasmin intravitreal injection, in subjects diagnosed with exudative AMD with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal ocriplasmin may offer physicians a safe agent for pharmacologic vitreolysis and nonsurgical resolution of focal vitreomacular adhesion in AMD subjects where this adhesion may be causally associated with worse prognosis).

lead_sponsor: ThromboGenics

location_country:
United Kingdom
Italy
United States
France
Belgium
Germany

location_facility: Wolverhampton Eye Infirmary New Cross Hospital

location_facility: Klinik für Augenheilkunde, Universitätsklinikum Gießen, Standort Marburg

location_facility: Centre Ophtalmologique d'Imagerie et de Laser

location_facility: University of Milan Department of Clinical Science "Luigi Sacco"

location_facility: Allegheny Ophthalmic & Orbital Associates, PC

location_facility: Universität Lübeck Universitätsklinikum Schleswig-Holstein

location_facility: Retina-Vitreous Associates Medical Group

location_facility: Largo Agostino Gemelli (University Hospital) Institute of Ophthalmology

location_facility: Augenklinik der Ludwig Maximilians Universität München


title: Long-term Extension, Multicentre, Multi-international Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg, 1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

ReferenceCitation: Benza RL, Ghofrani HA, Grünig E, Hoeper MM, Jansa P, Jing ZC, Kim NH, Langleben D, Simonneau G, Wang C, Busse D, Meier C, Ghio S. Effect of riociguat on right ventricular function in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. J Heart Lung Transplant. 2021 Oct;40(10):1172-1180. doi: 10.1016/j.healun.2021.06.020. Epub 2021 Jul 10.

ReferenceCitation: Saleh S, Becker C, Frey R, Mück W. Population pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of riociguat in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulm Circ. 2016 Mar;6(Suppl 1):S86-96. doi: 10.1086/685404.

ReferenceCitation: Simonneau G, D'Armini AM, Ghofrani HA, Grimminger F, Jansa P, Kim NH, Mayer E, Pulido T, Wang C, Colorado P, Fritsch A, Meier C, Nikkho S, Hoeper MM. Predictors of long-term outcomes in patients treated with riociguat for chronic thromboembolic pulmonary hypertension: data from the CHEST-2 open-label, randomised, long-term extension trial. Lancet Respir Med. 2016 May;4(5):372-80. doi: 10.1016/S2213-2600(16)30022-4. Epub 2016 Apr 8.

ReferenceCitation: Ghofrani HA, D'Armini AM, Grimminger F, Hoeper MM, Jansa P, Kim NH, Mayer E, Simonneau G, Wilkins MR, Fritsch A, Neuser D, Weimann G, Wang C; CHEST-1 Study Group. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N Engl J Med. 2013 Jul 25;369(4):319-29. doi: 10.1056/NEJMoa1209657.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Slovakia
Brazil
Canada
Switzerland
China
Germany
Denmark
Taiwan
Korea, Republic of
France

location_facility: Centro Hospitalar de Lisboa Norte - Hospital Santa Maria

summary: Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.


acronym: STARTT

title: A Multi-center, Randomized, Double Blind, Placebo-controlled Study of AMG 785 in Skeletally Mature Adults With a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation With an Intramedullary Nail

lead_sponsor: Amgen

ReferenceCitation: Bhandari M, Schemitsch EH, Karachalios T, Sancheti P, Poolman RW, Caminis J, Daizadeh N, Dent-Acosta RE, Egbuna O, Chines A, Miclau T. Romosozumab in Skeletally Mature Adults with a Fresh Unilateral Tibial Diaphyseal Fracture: A Randomized Phase-2 Study. J Bone Joint Surg Am. 2020 Aug 19;102(16):1416-1426. doi: 10.2106/JBJS.19.01008.

location_country:
United Kingdom
Italy
Lithuania
United States
Romania
Poland
Hong Kong
Russian Federation
Australia
India
Mexico
Norway
Slovakia
Canada
Hungary
Germany
Bulgaria
Denmark
Greece
Latvia
Estonia
New Zealand
France

summary: The primary objective of this study is to investigate the effect of romosozumab compared with placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in the midsection of the shinbone).


title: An Open-label, Multicenter Phase II Study to Compare the Efficacy and Safety of RAD001 as First-line Followed by Second-line Sunitinib Versus Sunitinib as First-line Followed by Second-line RAD001 in the Treatment of Patients With Metastatic Renal Cell Carcinoma.

ReferenceCitation: Voss MH, Chen D, Reising A, Marker M, Shi J, Xu J, Ostrovnaya I, Seshan VE, Redzematovic A, Chen YB, Patel P, Han X, Hsieh JJ, Hakimi AA, Motzer RJ. PTEN Expression, Not Mutation Status in TSC1, TSC2, or mTOR, Correlates with the Outcome on Everolimus in Patients with Renal Cell Carcinoma Treated on the Randomized RECORD-3 Trial. Clin Cancer Res. 2019 Jan 15;25(2):506-514. doi: 10.1158/1078-0432.CCR-18-1833. Epub 2018 Oct 16.

ReferenceCitation: Knox JJ, Barrios CH, Kim TM, Cosgriff T, Srimuninnimit V, Pittman K, Sabbatini R, Rha SY, Flaig TW, Page RD, Beck JT, Cheung F, Yadav S, Patel P, Geoffrois L, Niolat J, Berkowitz N, Marker M, Chen D, Motzer RJ. Final overall survival analysis for the phase II RECORD-3 study of first-line everolimus followed by sunitinib versus first-line sunitinib followed by everolimus in metastatic RCC. Ann Oncol. 2017 Jun 1;28(6):1339-1345. doi: 10.1093/annonc/mdx075. Erratum in: Ann Oncol. 2018 Nov 1;29(11):2269.

ReferenceCitation: Motzer RJ, Barrios CH, Kim TM, Falcon S, Cosgriff T, Harker WG, Srimuninnimit V, Pittman K, Sabbatini R, Rha SY, Flaig TW, Page R, Bavbek S, Beck JT, Patel P, Cheung FY, Yadav S, Schiff EM, Wang X, Niolat J, Sellami D, Anak O, Knox JJ. Phase II randomized trial comparing sequential first-line everolimus and second-line sunitinib versus first-line sunitinib and second-line everolimus in patients with metastatic renal cell carcinoma. J Clin Oncol. 2014 Sep 1;32(25):2765-72. doi: 10.1200/JCO.2013.54.6911. Epub 2014 Jul 21.

location_country:
Denmark
Taiwan
Brazil
Hong Kong
Spain
Italy
United Kingdom
Australia
Netherlands
Argentina
Canada
Thailand
Korea, Republic of
United States
France
Peru
Turkey
Mexico
Germany

location_facility: University of Oklahoma Health Sciences Center Dept of OHSC

location_facility: Weinberg Cancer Institute at Franklin Square Hospital

location_facility: The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2)

location_facility: Loyola University Medical Center /Cardinal Bernardin Cancer Cardinal Bernardin Cancer (3)

location_facility: Georgia Health Sciences University Dept. of MCG

location_facility: SUNY - Upstate Medical University Div. of Hematology-Oncology

location_facility: VA Maryland Health Care Dept.of GreenbaumCancerCent(7)

location_facility: Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Ctr (2

location_facility: The West Clinic Dept. of the West Clinic

location_facility: Memorial Sloan Kettering Cancer Center Dept. of MSKCC

location_facility: University of North Carolina Dept. of LinbergerCancerCtr(3)

location_facility: MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando

location_facility: University of California at Los Angeles Dept. of UCLA (3)

location_facility: University of Colorado Dept. of Anschutz Cancer (2)

location_facility: St. Luke's Hospital and Health Network St Luke's Hospital (2)

location_facility: East Texas Medical Center Cancer Institute

location_facility: Crescent City Research Consortium, LLC SC

location_facility: Hackensack University Medical Center DeptofHackensackUniv.MedCtr.

location_facility: Billings Clinic Dept of Billings Clinic(2)

location_facility: University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.

location_facility: Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)

location_facility: NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Dept.ofNorthwesternMemHospital

location_facility: University of Alabama at Birmingham/ Kirklin Clinic Comprehensive CancerCenter (1)

location_facility: Highlands Oncology Group HighlandsOncGrp-Bentonville(2)

location_facility: University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (5)

location_facility: University Cancer & Blood Center, LLC Dept of NE GCC (2)

summary: This study assessed the efficacy and safety of first-line RAD001 followed by second-line sunitinib versus the opposite sequence: first-line sunitinib followed by second-line RAD001 for the treatment of patients with MRCC.


title: A Single-arm, Multicenter, Proof-of-concept Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium Despite Recent Treatment With IV Bisphosphonates

ReferenceCitation: Hu MI, Glezerman I, Leboulleux S, Insogna K, Gucalp R, Misiorowski W, Yu B, Ying W, Jain RK. Denosumab for patients with persistent or relapsed hypercalcemia of malignancy despite recent bisphosphonate treatment. J Natl Cancer Inst. 2013 Sep 18;105(18):1417-20. doi: 10.1093/jnci/djt225. Epub 2013 Aug 29.

location_country:
Poland
Italy
Canada
United States
France

summary: The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia of Malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates by lowering corrected serum calcium </= 11.5 mg/dL (2.9 millimoles /L) by day 10.


acronym: β-SPECIFIC 3

title: An Open-label Extension Study of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations Who Participated in Studies ACZ885G2301 and ACZ885G2305; and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever

ReferenceCitation: Ruperto N, Brunner HI, Quartier P, Constantin T, Wulffraat NM, Horneff G, Kasapcopur O, Schneider R, Anton J, Barash J, Berner R, Corona F, Cuttica R, Fouillet-Desjonqueres M, Fischbach M, Foster HE, Foell D, Radominski SC, Ramanan AV, Trauzeddel R, Unsal E, Levy J, Vritzali E, Martini A, Lovell DJ; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials. Ann Rheum Dis. 2018 Dec;77(12):1710-1719. doi: 10.1136/annrheumdis-2018-213150. Epub 2018 Sep 29.

ReferenceCitation: Grom AA, Ilowite NT, Pascual V, Brunner HI, Martini A, Lovell D, Ruperto N; Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group, Leon K, Lheritier K, Abrams K. Rate and Clinical Presentation of Macrophage Activation Syndrome in Patients With Systemic Juvenile Idiopathic Arthritis Treated With Canakinumab. Arthritis Rheumatol. 2016 Jan;68(1):218-28. doi: 10.1002/art.39407.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Poland
Austria
Russian Federation
Argentina
Israel
Turkey
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Greece
France
Netherlands

summary: This open-label extension study will permit patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who previously were responsive to treatment with canakinumab and canakinumab treatment-naïve patients with active SJIA with and without fever to be retreated with 4 mg/kg s.c. every 4 weeks and assessed for continued efficacy and safety until discontinuation or when study CACZ885G2402 is in place at their study center or around March 2013, whichever occurs first. Patients who are steroid-free will be able to taper their canakinumab dose to 2 mg/kg s.c. every 4 weeks.


title: A Randomized, Double-blind, Placebo Controlled, Withdrawal Study of Flare Prevention of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations

acronym: β-SPECIFIC 2

summary: This two-part study assessed the sustained efficacy of canakinumab in the double-blind Part II and the ability to taper steroids in the open label Part I.

ReferenceCitation: Brachat AH, Grom AA, Wulffraat N, Brunner HI, Quartier P, Brik R, McCann L, Ozdogan H, Rutkowska-Sak L, Schneider R, Gerloni V, Harel L, Terreri M, Houghton K, Joos R, Kingsbury D, Lopez-Benitez JM, Bek S, Schumacher M, Valentin MA, Gram H, Abrams K, Martini A, Lovell DJ, Nirmala NR, Ruperto N; Pediatric Rheumatology International Trials Organization (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Early changes in gene expression and inflammatory proteins in systemic juvenile idiopathic arthritis patients on canakinumab therapy. Arthritis Res Ther. 2017 Jan 23;19(1):13. doi: 10.1186/s13075-016-1212-x.

ReferenceCitation: Ruperto N, Brunner HI, Quartier P, Constantin T, Wulffraat N, Horneff G, Brik R, McCann L, Kasapcopur O, Rutkowska-Sak L, Schneider R, Berkun Y, Calvo I, Erguven M, Goffin L, Hofer M, Kallinich T, Oliveira SK, Uziel Y, Viola S, Nistala K, Wouters C, Cimaz R, Ferrandiz MA, Flato B, Gamir ML, Kone-Paut I, Grom A, Magnusson B, Ozen S, Sztajnbok F, Lheritier K, Abrams K, Kim D, Martini A, Lovell DJ; PRINTO; PRCSG. Two randomized trials of canakinumab in systemic juvenile idiopathic arthritis. N Engl J Med. 2012 Dec 20;367(25):2396-406. doi: 10.1056/NEJMoa1205099.

location_country:
Poland
Brazil
Spain
Italy
Netherlands
Argentina
Canada
Switzerland
Sweden
Hungary
United States
France
Israel
Peru
Belgium
Norway
Germany
South Africa
Turkey

location_facility: New England Medical Center - Department of Allergy

location_facility: Arkansas Children's Hospital Research Inst


acronym: MOVE

intervention_type: Dietary Supplement

title: Comparison of the Effects of Teriparatide With Those of Risedronate on Lumbar Spine BMD (Bone Mineral Density) in Men and Postmenopausal Women With Low Bone Mass and a Recent Pertrochanteric Hip Fracture

lead_sponsor: Eli Lilly and Company

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Denmark
Croatia
Spain
Greece
Italy
Canada
United States
France
Mexico
Norway
Germany
Czechia

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

summary: This study will evaluate whether teriparatide is superior to the active comparator in the change from baseline of lumbar spine BMD (bone mineral density) in men and postmenopausal women with low bone mass and a recent pertrochanteric hip fracture.


acronym: β-SPECIFIC 1

title: A Randomized, Double-blind, Placebo Controlled, Single-dose Study to Assess the Initial Efficacy of Canakinumab (ACZ885) With Respect to the Adapted ACR Pediatric 30 Criteria in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
South Africa
Poland
Argentina
Israel
Turkey
Norway
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Greece
France
Netherlands

location_facility: Tufts New England Medical Center-Dept. of Allergy

summary: This study assessed the initial efficacy and safety of canakinumab over a 4 week period in patients with systemic juvenile idiopathic arthritis (SJIA) having a flare. Response to treatment will be according to the adapted American College of Rheumatology(ACR)Pediatric 30 criteria at Day 15.


title: A Dose-ranging, Randomized, Double-blind , Placebo-controlled Study of the Effect of RO5313534, Used as add-on Therapy to Donepezil, on Cognitive Function in Patients With Mild to Moderate Symptoms of Alzheimer's Disease

summary: This 4 arm study will assess the efficacy and safety of RO5313534 (MEM3454) versus placebo added to donepezil, in patients with mild to moderate Alzheimer's disease. Following a screening period, patients will be randomized to one of 4 treatments (placebo, or RO5313534 1mg, 5mg or 15mg po daily) with background therapy of donepezil (5mg or 10mg).The anticipated time on study treatment is 6 months, and the target sample size is 100-500 individuals.

location_country:
Poland
Romania
Spain
Italy
United Kingdom
Australia
Argentina
Canada
United States
France
Mexico
Germany
Slovakia


title: A Phase III, Open Label, Randomized, 2 Arm Study of Ixabepilone Administered Every 21 Days Versus Paclitaxel or Doxorubicin Administered Every 21 Days in Women With Advanced Endometrial Cancer Who Have Previously Been Treated With Chemotherapy

lead_sponsor: R-Pharm

ReferenceCitation: McMeekin S, Dizon D, Barter J, Scambia G, Manzyuk L, Lisyanskaya A, Oaknin A, Ringuette S, Mukhopadhyay P, Rosenberg J, Vergote I. Phase III randomized trial of second-line ixabepilone versus paclitaxel or doxorubicin in women with advanced endometrial cancer. Gynecol Oncol. 2015 Jul;138(1):18-23. doi: 10.1016/j.ygyno.2015.04.026. Epub 2015 Apr 26.

location_country:
Denmark
Brazil
Spain
Greece
Italy
Australia
Mexico
Argentina
Canada
Czech Republic
Russian Federation
United Kingdom
Hungary
United States
France
Peru
Belgium
Norway
Sweden

location_facility: Pennsylvania Oncology Hematology Associates

location_facility: Peggy And Charles Stephenson Oklahoma Cancer Center

location_facility: Hematology And Oncology Specialists, Llc

location_facility: St. Vincent Hospital And Health Care Center, Inc.

location_facility: Magee-Womens Hospital Of Upmc Laboratory

location_facility: Tennessee Gynecologic Oncology Group, Llc

summary: The primary purpose of this study is to investigate whether administration of ixabepilone results in superior outcome as assessed by overall survival compared with that achieved with standard chemotherapy (paclitaxel or doxorubicin) in women with advanced endometrial cancer that has progressed following first-line chemotherapy.


title: Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple Sclerosis

summary: To look at the ability of LY2127399 to reduce magnetic resonance imaging (MRI) lesions at 12, 16, 20, and 24 weeks compared to placebo.

location_country:
Poland
Serbia
Russian Federation
Ukraine
Hungary
United States
France
Israel
Romania
Germany
Bulgaria
Slovakia
Czechia


title: A 104 Week, Randomized, Double Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy of Aliskiren on the Progression of Atherosclerosis in Patients With Coronary Artery Disease When Added to Optimal Background Therapy

acronym: AQUARIUS

summary: The study will assess the change in coronary atherosclerotic disease as determined by intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the pre-hypertensive range.

ReferenceCitation: Puri R, Nissen SE, Menon V, Shao M, Hsu A, Bakris GL, Kastelein JJ, Williams B, Armbrecht J, Brunel P, Kataoka Y, Nicholls SJ. Effects of aliskiren in diabetic and non-diabetic patients with coronary artery disease: Insights from AQUARIUS. Atherosclerosis. 2015 Dec;243(2):553-9. doi: 10.1016/j.atherosclerosis.2015.10.019. Epub 2015 Oct 20.

ReferenceCitation: Nicholls SJ, Bakris GL, Kastelein JJ, Menon V, Williams B, Armbrecht J, Brunel P, Nicolaides M, Hsu A, Hu B, Fang H, Puri R, Uno K, Kataoka Y, Bash D, Nissen SE. Effect of aliskiren on progression of coronary disease in patients with prehypertension: the AQUARIUS randomized clinical trial. JAMA. 2013 Sep 18;310(11):1135-44. doi: 10.1001/jama.2013.277169.

location_country:
Poland
Spain
Italy
Australia
Argentina
Canada
Hungary
United States
France
Belgium
Germany


title: A Randomized, Double-Blind Extension Study To Assess The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures

lead_sponsor: Eisai Inc.

location_country:
Denmark
Montenegro
Poland
Taiwan
Serbia
Spain
Greece
Italy
Australia
Russian Federation
United Kingdom
Switzerland
Sweden
Hungary
Korea, Republic of
France
India
South Africa
Germany
Slovakia

summary: The purpose of this study is to assess the long-term safety and tolerability and to explore the long-term efficacy of zonisamide as monotherapy treatment in subjects with newly diagnosed partial seizures.