title: Long-term Open-label Study in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis Who Completed the Protocol AC-052-330.

acronym: BUILD 2 OL

summary: This study will asses the long term safety and efficacy of oral bosentan to patients suffering from Interstitial Lung Disease.

lead_sponsor: Actelion

location_country:
Germany
France
Italy
United Kingdom
Sweden
Netherlands
Switzerland
United States
Korea, Republic of
Canada
Israel

location_facility: SoonChunHyang University Bucheon Hospital

location_facility: University of Michigan Health System - Division of Pulmonary & Critical Care Medicine

location_facility: University of Illinois College of Medicine

location_facility: University of Washington - Division of Pulmonary & Critical Care Medicine


title: Reduced Factorial Design, Randomized, Double Blind Trial Comparing Combinations of Telmisartan 20 or 80 mg and Simvastatin 20 or 40 mg With Single Component Therapies in the Treatment of Hypertension and Dyslipidemia

summary:
This study will investigate two registered drugs, one for the treatment of high blood pressure and one for the treatment of elevated cholesterol. High blood pressure (hypertension) is a common medical condition affecting millions of people worldwide. A wide variety of effective drug treatments is available to reduce blood pressure. Elevated cholesterol (hypercholesterolemia) is a common medical condition affecting people worldwide. A wide variety of effective drug treatments is available to reduce cholesterol levels.

Hypertension and hypercholesterolemia often occur together. They are both important risk factors for the development of heart and vessel diseases (e.g. heart attack or stroke). Current guidelines advise treatment of high blood pressure and elevated cholesterol to reduce the risk of cardiovascular diseases. This study will test the simultaneous use of a drug to reduce blood pressure and a drug to reduce elevated cholesterol. Both drugs are registered and are effective. The drug for treatment of high blood pressure is telmisartan Micardis). The drug for treatment of elevated cholesterol is simvastatin (Zocor). Since hypertension and hypercholesterolemia frequently occur together, the purpose of this study is to investigate whether both drugs can be used simultaneously. A low dose and a high dose of these drugs will be used. It will be investigated whether each of the drugs is still as effective when given together, at the same time of day, with the other drug.

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Slovakia
Hong Kong
Sweden
Netherlands
Korea, Republic of
South Africa
Taiwan
Ukraine
Czech Republic
Russian Federation
France

location_facility: Julius Center for Patient oriented Research

location_facility: Boehringer Ingelheim Investigational Site

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study Evaluating PD-0299685 for Treatment of Vasomotor Symptoms Associated With Menopause

summary: The primary purpose of this study is to determine if PD-0299685 is effective and safe in the treatment of vasomotor symptoms (hot flashes / flushes) associated with menopause.

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Pfizer

location_country:
Australia
United States
Spain
South Africa
Canada
France


title: Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg in Postmenopausal Women With ER +ve Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy

acronym: FINDER II

summary: This study will assess the relationship between fulvestrant dose and efficacy in postmenopausal women with oestrogen receptor positive advanced breast cancer.

study_start_date_type: Actual

ReferenceType: derived

ReferenceCitation: Pritchard KI, Rolski J, Papai Z, Mauriac L, Cardoso F, Chang J, Panasci L, Ianuli C, Kahan Z, Fukase K, Lindemann JP, Macpherson MP, Neven P. Results of a phase II study comparing three dosing regimens of fulvestrant in postmenopausal women with advanced breast cancer (FINDER2). Breast Cancer Res Treat. 2010 Sep;123(2):453-61. doi: 10.1007/s10549-010-1022-9. Epub 2010 Jul 15.

lead_sponsor: AstraZeneca

location_country: Poland Hungary Romania Belgium Turkey Czechia Canada France


title: Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes

summary: The trial is conducted in Europe and Middle East. The aim of the trial is to compare the use of Insulin Detemir once or twice daily combined with mealtime Insulin Aspart against that of NPH Insulin once or twice daily combined with mealtime Insulin Aspart. The trial involves children and adolescents with Type 1 Diabetes.

ReferenceType: result

ReferenceCitation: Robertson KJ, Schoenle E, Gucev Z, Mordhorst L, Gall MA, Ludvigsson J. Insulin detemir compared with NPH insulin in children and adolescents with Type 1 diabetes. Diabet Med. 2007 Jan;24(1):27-34. doi: 10.1111/j.1464-5491.2007.02024.x.

lead_sponsor: Novo Nordisk A/S

location_country: Macedonia, The Former Yugoslav Republic of


type: Other Identifier

title: A Multicenter, Open-Label, Long-Term, Safety, Tolerability and Efficacy Study of Retigabine in Adult Epilepsy Patients With Partial-Onset Seizures (Extension of Study VRX-RET-E22-302)

summary: This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-302 trial. Patients who have completed the VRX-RET-E22-302 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation. Treatment will be continued until the subject withdraws from the study or until the program is discontinued. Patients will be recruited from 55-60 sites in Europe, Israel, Australia, and South Africa. The primary objective of the study is to evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who completed the double-blind Study VRX-RET-E22-302. Secondary objectives are: to evaluate efficacy of long-term treatment with retigabine and patient quality of life and to evaluate whether retinal pigmentation, unexplained vision loss, pigmentation of non-retinal ocular tissue, and discoloration of nails, lips, skin or mucosa change over time after discontinuation of retigabine.

status: Terminated

design_allocation: Non-Randomized

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.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Poland
Hungary
Israel
United Kingdom
Australia
Belgium
Spain
South Africa
Ukraine
Russian Federation
France

location_facility: Hospital Universitario Lozano Blesa Neurology Service

location_facility: Orszagos Idegsebeszeti Tudomanyos Intezet

location_facility: Oddzial Neurologii -- Klinika Neurologii ICZMP

location_facility: Odessa Regional Clinical Hospital Center for Neurology and Neurosurgery

location_facility: Wojewodzki Szpital Specjalistyczny im.Mikolaja Kopernika

location_facility: Orszagos Pszichiatriai es Neurologiai Intezet

location_facility: Pavlov State Medical University Clinic and Department of Neurology

location_facility: Zentrum Epilepsie Erlangen (ZEE) der Universitaet Erlangen

location_facility: Epilepsy Center of Municipal Clinical Psychoneurological Hospital

location_facility: Instytut Psychiatrii i Neurologii II Oddzial Neurologii

location_facility: Prywatna Wielospecjalistyczna Lecznica Medyczna "Zycie"

location_facility: Universitaetsklinik Mainz Neurologische Klinik

location_facility: General Hospital Middelheim -- Department of Neurology

location_facility: Hopital Civil de Steasbourg Clinique Neurologie

location_facility: Universitaire Ziekenhuizen Gasthuisberg -- Department Neurology

location_facility: Universitaet Giessen / Marburg Neurologie

location_facility: District Antiepileptic Centre City Clinical Hospital # 71

location_facility: Pecs University of Science, Clinic of Neurology

location_facility: Institute of Neurology, Psychiatry and Narcology of AMS, Ukr

location_facility: Psychosomatic Center of Dnepropetr. Regional Clinic

location_facility: University of Bonn -- Department for Epileptplogy

location_facility: NZOZ Przychodnia Internistyczno - Stomatologiczna "Kendron"

location_facility: Universitaetslinkum Ulm Poliklinik fuer Neurologie

location_facility: Specjalistyczna Przychodnia Lekarska Medikard

status_simplified: Unknown


title: Extension Study of Iron Chelation Therapy With Deferasirox in β-thalassemia and Other Patients With Rare Chronic Anemia and Transfusional Iron Overload

summary:
A 1-year randomized Phase II core trial was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia and other rare chronic anemia 2 years of age and older. Patients who successfully completed the main trial may continue in the extension trial to receive chelation therapy with deferasirox for up to 3 years. Extension was prolonged to 4 years.

The objective of this study is to assess the long-term safety and efficacy of deferasirox in these patient groups.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
United Kingdom
Belgium
United States
Canada
France

location_facility: Children's Hospital and Research center at Oakland


title: A Multicentre, Randomised, Double Blind, Double Dummy, Active Comparator Controlled, Parallel Group Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis

summary: The purpose of this study is to investigate whether a novel dosage form of a prednisolone ester, called COLAL-PRED®, is useful in the treatment of ulcerative colitis.

lead_sponsor: Alizyme

location_country:
Germany
Italy
Poland
Hungary
Israel
Denmark
Australia
Sweden
United Kingdom
Belgium
Spain
South Africa
Czech Republic
Russian Federation
France

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Klinika Gastroenterologii

location_facility: SPSK Nr 1 im. Prof. Tadeusza Sokolowskiego Pomorskiej Akademii Medycznej Klinika Gastroenterologii i Chorob Wewnetrznych

location_facility: Samodzielny Publiczny Szpital Kliniczny, Klinika Gastroenterologii i Chorob Wewnetrznych

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Centrum Onkologii-Instytutu im. Marii Skłodowskiej-Curie Klinika Gastroenterologii

location_facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Katedra i Klinika Gastroenterologii i Chorób Przemiany Materii

location_facility: Wojskowy Szpital Kliniczny z Poliklinika Oddzial Gastroenterologii

location_facility: SP ZOZ Uniwersytecki Szpital Kliniczny Nr 5 im. gen. dyw. Boleslawa Szareckiego Uniwersytetu Medycznego w Lodzi Oddział Gastroenterologii i Chorob Wewnetrznych

location_facility: Szpital Kolejowy w Pruszkowie Oddzial Wewnetrzny


title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial With 40-Week Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate For Smoking Cessation In Patients With Mild-To-Moderate Chronic Obstructive Pulmonary Disease

summary: This study is to be conducted in subjects with mild-to-moderate COPD who are cigarette smokers with the intent of demonstrating differences in smoking cessation between varenicline and placebo.

ReferenceCitation: Tashkin DP, Rennard S, Taylor Hays J, Lawrence D, Marton JP, Lee TC. Lung function and respiratory symptoms in a 1-year randomized smoking cessation trial of varenicline in COPD patients. Respir Med. 2011 Nov;105(11):1682-90. doi: 10.1016/j.rmed.2011.04.016. Epub 2011 May 31.

ReferenceCitation: Tashkin DP, Rennard S, Hays JT, Ma W, Lawrence D, Lee TC. Effects of varenicline on smoking cessation in patients with mild to moderate COPD: a randomized controlled trial. Chest. 2011 Mar;139(3):591-599. doi: 10.1378/chest.10-0865. Epub 2010 Sep 23.

ReferenceCitation: Ryerson CJ, Berkeley J, Carrieri-Kohlman VL, Pantilat SZ, Landefeld CS, Collard HR. Depression and functional status are strongly associated with dyspnea in interstitial lung disease. Chest. 2011 Mar;139(3):609-616. doi: 10.1378/chest.10-0608. Epub 2010 Aug 5.

location_country:
United States
Italy
Spain
France


title: A Phase 3, Randomized, 6-Month, Double-Blind Trial in Subjects With Bipolar I Disorder to Evaluate the Continued Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer (vs Placebo Plus a Mood Stabilizer) Following a Minimum of 2 Months of Response to Open-Label Treatment With Both Agents

summary: The purpose of this study is to determine if ziprasidone plus a mood stabilizer will continue to be a safe and effective treatment regimen for adults with Bipolar I Disorder (manic or mixed symptoms) after they have achieved 8 consecutive weeks of symptom improvement on the regimen.

ReferenceCitation: Bowden CL, Vieta E, Ice KS, Schwartz JH, Wang PP, Versavel M. Ziprasidone plus a mood stabilizer in subjects with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind trial. J Clin Psychiatry. 2010 Feb;71(2):130-7. doi: 10.4088/JCP.09m05482yel. Epub 2010 Jan 26.

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

location_country:
Germany
Italy
Guatemala
India
Venezuela
Hong Kong
Mexico
United States
Spain
Chile
Taiwan
Russian Federation
France


title: A 6-Month, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Safety, Tolerability, and Efficacy Study of 3 Doses of Lecozotan (SRA-333) SR in Outpatients With Mild to Moderate Alzheimer's Disease Treated With a Cholinesterase Inhibitor

summary: The purpose of the study is to determine the safety, tolerability, and efficacy of 3 doses of lecozotan in combination with a cholinesterase inhibitor in patients with mild to moderate Alzheimer's disease (AD).

location_country:
Finland
Italy
Poland
United Kingdom
Argentina
Australia
United States
Spain
South Africa
Canada
France


title: An Open-label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 80 mg + Hydrochlorothiazide 25 mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension.

summary: The primary objective is to assess the efficacy and safety of the fixed dose combination of telmisartan 80 mg + hydrochlorothiazide 25 mg (T80/H25) alone or in addition to other antihypertensive therapies during open-label, long-term treatment.

ReferenceCitation: Neldam S, Edwards C. Long-term, open-label evaluation of the safety and efficacy of telmisartan 80 mg/hydrochlorothiazide 25 mg fixed-dose combination alone or with other antihypertensive medication. Expert Opin Pharmacother. 2009 Feb;10(3):345-52. doi: 10.1517/14656560802707937.

location_country:
Finland
Germany
Ireland
Italy
Norway
Hong Kong
Denmark
Sweden
Netherlands
Switzerland
Korea, Republic of
Spain
Malaysia
South Africa
Taiwan
France

location_facility: Azienda Ospedaliera Universita di Ferrara

location_facility: Boehringer Ingelheim Investigational Site


type: EudraCT Number

title: A Phase II Study of Lapatinib for Brain Metastases in Subjects With ErbB2-Positive Breast Cancer Following Trastuzumab-based Systemic Therapy and Cranial Radiotherapy

summary: Determine how safe and effective lapatinib is when used to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during the course of the study.

ReferenceCitation: Sutherland S, Ashley S, Miles D, Chan S, Wardley A, Davidson N, Bhatti R, Shehata M, Nouras H, Camburn T, Johnston SR. Treatment of HER2-positive metastatic breast cancer with lapatinib and capecitabine in the lapatinib expanded access programme, including efficacy in brain metastases--the UK experience. Br J Cancer. 2010 Mar 16;102(6):995-1002. doi: 10.1038/sj.bjc.6605586. Epub 2010 Feb 23.

ipd_sharing: Undecided

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Germany
Italy
Poland
India
United Kingdom
Australia
Japan
Sweden
Austria
Belgium
Switzerland
United States
Spain
Greece
Taiwan
Canada
France


title: Randomized, Open-Label, Comparative Parallel Group Study to Assess Efficacy and Safety on Flexible Dosages of OROS Hydromorphone Once-Daily Compared to Sustained Release Oxycodone Twice Daily in Subjects With Chronic Non-malignant Pain Requiring Continuous Opioid Therapy.

summary: The purpose of this study is to compare the effectiveness and safety of sustained- release hydromorphone, formulated to release slowly over time, taken once daily, and controlled- release oxycodone taken twice daily, in patients with chronic non-cancer pain. The study will also determine the dose of sustained-release hydromorphone that provides a level of pain control that is equal to the pain control provided by control-released oxycodone (equi-analgesic dosage).

ReferenceCitation: Binsfeld H, Szczepanski L, Waechter S, Richarz U, Sabatowski R. A randomized study to demonstrate noninferiority of once-daily OROS((R)) hydromorphone with twice-daily sustained-release oxycodone for moderate to severe chronic noncancer pain. Pain Pract. 2010 Sep-Oct;10(5):404-15. doi: 10.1111/j.1533-2500.2009.00342.x.

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Germany
Slovenia
Poland
Slovakia
Norway
Denmark
Sweden
Switzerland
Czech Republic
France


title: A Randomized Phase 2 Study Of SU011248 Versus Standard-Of-Care For Patients With Previously Treated, Advanced, Triple Receptor Negative (ER, PR, HER2) Breast Cancer

summary: The purpose of this study is to compare progression free survival for SU011248 [sutent (sunitinib malate)] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer.

ReferenceCitation: Curigliano G, Pivot X, Cortes J, Elias A, Cesari R, Khosravan R, Collier M, Huang X, Cataruozolo PE, Kern KA, Goldhirsch A. Randomized phase II study of sunitinib versus standard of care for patients with previously treated advanced triple-negative breast cancer. Breast. 2013 Oct;22(5):650-6. doi: 10.1016/j.breast.2013.07.037. Epub 2013 Aug 17.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

location_country:
Germany
Italy
Hungary
United Kingdom
United States
Spain
Turkey
Ukraine
Bulgaria
Canada
Czech Republic
France


title: A Randomized, Double Blind, Double Dummy, Parallel Group, Placebo Controlled Study to Evaluate the Pharmacodynamic and Pharmacokinetic Response and Safety and Tolerability of SB424323 (250mg, 375mg and 500 mg) Administered Twice Daily for 16 Weeks, on Top of Asprin (325mg, qd) in Men and Women With Non Valvular Atrial Fibrillation at a Low or Intermediate Risk for Stroke

summary: This study will allow determination of the pharmacokinetic and pharmacodynamics of SB424323 in a relevant population. The data from this study will be used along with other data to aid in choosing the most appropriate dose for the later phase study.

primary_purpose: Prevention

location_country:
Germany
New Zealand
Argentina
Brazil
Thailand
Canada
France
Hungary
Denmark
United States
Latvia
India
Romania
Belgium
Estonia
Italy
Norway
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Sweden


title: A Prospective Randomised Study to Compare a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 25 mg With a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg in Patients With Uncontrolled Hypertension Who Fail to Respond Adequately to Treatment With a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg

summary: The primary objective of this trial is to demonstrate that a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 25 mg (T80/H25) is superior in reducing blood pressure after eight weeks compared with a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg (T80/H12.5) in patients who fail to respond to six weeks treatment with T80/H12.5.

location_facility: Hospital General de Mostoles - Medicina Interna


title: Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase 3 Study - Determine Efficacy and Safety of Two Doses of Retigabine (900 Mg/Day and 600 Mg/Day) Used as Adjunctive Therapy in Refractory Epilepsy Patients With Partial-Onset Seizures

summary: This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).

ReferenceType: background

ReferenceCitation: Brodie MJ, Lerche H, Gil-Nagel A, Elger C, Hall S, Shin P, Nohria V, Mansbach H; RESTORE 2 Study Group. Efficacy and safety of adjunctive ezogabine (retigabine) in refractory partial epilepsy. Neurology. 2010 Nov 16;75(20):1817-24. doi: 10.1212/WNL.0b013e3181fd6170. Epub 2010 Oct 13.

ReferenceCitation: Tompson DJ, Crean CS. Clinical pharmacokinetics of retigabine/ezogabine. Curr Clin Pharmacol. 2013 Nov;8(4):319-31. doi: 10.2174/15748847113089990053.

ReferenceCitation: Brickel N, Gandhi P, VanLandingham K, Hammond J, DeRossett S. The urinary safety profile and secondary renal effects of retigabine (ezogabine): a first-in-class antiepileptic drug that targets KCNQ (K(v)7) potassium channels. Epilepsia. 2012 Apr;53(4):606-12. doi: 10.1111/j.1528-1167.2012.03441.x. Epub 2012 Mar 16.

ReferenceCitation: Porter RJ, Burdette DE, Gil-Nagel A, Hall ST, White R, Shaikh S, DeRossett SE. Retigabine as adjunctive therapy in adults with partial-onset seizures: integrated analysis of three pivotal controlled trials. Epilepsy Res. 2012 Aug;101(1-2):103-12. doi: 10.1016/j.eplepsyres.2012.03.010. Epub 2012 Apr 16.

sponsor_collaborators:
GlaxoSmithKline
Bausch Health Americas, Inc.

location_country:
Germany
Poland
Hungary
Israel
United Kingdom
Australia
Belgium
United States
Spain
South Africa
Ukraine
Russian Federation
France

location_facility: Orszagos Idegsebeszeti Tudomanyos Intezet

location_facility: St.Petersburg State Medical University n.a. I.P.Pavlov

location_facility: A. Z. Middelheim -- Department of Neurology

location_facility: Walton Centre for Neurology & Neurosurgery

location_facility: Wojewodzki Szpital Specjalistyczny im.Mikolaja Kopernika

location_facility: Zentrum Epilepsie Erlangen (ZEE) der Universitaet Erlangen

location_facility: Clinic of Nervous Diseases of Sechenov's Moscow Med. Academy

location_facility: Epilepsy Center of Municipal Clinical Psychoneurological Hospital

location_facility: Instytut Psychiatrii i Neurologii II Oddzial Neurologii

location_facility: Prywatna Wielospecjalistyczna Lecznica Medyczna "Zycie"

location_facility: Universitaetsklinik Mainz Neurologische Klinik

location_facility: Katedra i Klinika Neurologii Slaskiej Akademii Medycznej

location_facility: Universitaire Ziekenhuizen Gasthuisberg -- Department Neurology

location_facility: Universitaet Giessen / Marburg Neurologie

location_facility: District Antiepileptic Centre City Clinical Hospital # 71

location_facility: Institute of Neurology, Psychiatry and Narcology of AMS, Ukr

location_facility: Psychosomatic Center of Dnepropetr. Regional Clinic

location_facility: University of Bonn -- Department for Epileptplogy

location_facility: Interregional Clinical Diagnostic Centre

location_facility: NZOZ Przychodnia Internistyczno - Stomatologiczna "Kendron"


title: Phase II, Multicentre, Randomized, Double-blind Study in Acromegalic Patients Evaluating the Efficacy and Safety of a Single Deep Subcutaneous Administration of Lanreotide Autogel (60, 90 or 120mg) Versus Placebo Followed by a Single Blind Fixed Dose Phase Evaluating the Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Profile of Multiple Deep Subcutaneous Administrations of Lanreotide Autogel (60, 90 & 120mg) Ending in Open Label Dose Titration Phase.

summary: The purpose of this study is to compare the effectiveness of lanreotide autogel to placebo after a single injection. Effectiveness and safety were then also assessed following four fixed-dose injections and after one year of treatment given at titrated doses.

ReferenceCitation: Melmed S, Cook D, Schopohl J, Goth MI, Lam KS, Marek J. Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension. Pituitary. 2010;13(1):18-28. doi: 10.1007/s11102-009-0191-1. Epub 2009 Jul 29.

lead_sponsor: Ipsen

location_country:
Germany
Hungary
Hong Kong
United Kingdom
Netherlands
United States
Czechia
France

location_facility: Johns Hopkins University School of Medicine

location_facility: Hôpital Cochin - Service d'Endocrinologie

location_facility: Hôpital Lariboisière - Service de Médecine B


title: An Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of Repeat Courses of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Patients With Chronic Plaque Psoriasis

summary: The purpose of this study is to determine whether repeat courses of alefacept, administered intramuscularly, are safe when given to chronic plaque psoriasis patients who are receiving standard dermatology treatments.

lead_sponsor: Biogen

location_country:
Germany
United Kingdom
Denmark
Netherlands
Austria
Switzerland
United States
Canada
France

location_facility: University of Medicine and Dentistry Robert Wood Jonhson Medical School

location_facility: Hospital Saint Louis, Université Paris VII

location_facility: Wake Forest University School of Medicine

location_facility: Eastern Canada Cutaneous Research Associates

location_facility: University Hospital Nijmegen - St. Radboud


title: A Phase II Randomised, Double-Blind, Stratified, Multi-Centre Trial Comparing the Nolvadex 20 Mg And Placebo Combination To The Nolvadex 20 Mg and ZD1839 (IRESSA™) 250 MG Combination In Patients With Metastatic Breast Cancer And Estrogen Receptor (ER) and/or Progesterone (PR) Positive Tumours

summary: This study is being carried out to see if ZD1839 is effective in treating metastatic breast cancer in combination with Nolvadex, and if so, how it compares with Nolvadex alone.

location_country:
Germany
United Kingdom
Argentina
Denmark
Australia
Brazil
Belgium
United States
Spain
South Africa
Canada
France


title: A 12-Month, Open-Label, Flexible-Dosage (100 to 250 mg/Day) Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients With Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder (With an Open-Ended Extension Period)

summary: A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

lead_sponsor: Cephalon

location_country:
Germany
Australia
United States
Canada
Puerto Rico
Russian Federation
France

location_facility:
Sleep Clinic of San Francisco
City Clinical Hospital 83
St. George Hospital
Hopital Guy de Chauliac
Peoria Pulmonary Associates
Monash Medical Center
Baycrest Hospital
North Coast Clinical Trials
Radiant Research Salt Lake
New York University
Southwest Cleveland Sleep Cent
Tri State Sleep Disorders Cent
Sleep Disorders Ctr of Alabama
Universitaires de Strasbourg
Royal Prince Alfred Hospital
Sleep and Neuropsychiatry Cent
West Parry Sound Health Center
Hopital Antoine Beclere
Sleep-Wake Disorder Center
Clinical Hospital Russian Scie
Dept Veterans Affairs Dayton
Radiant Research Marietta
Omega Medical Research
St. Thomas Sleep Disorders Cen
Sadler Clinic
Center for Sleep Disorders
Westmead Hospital
Ohio Sleep Medicine-Neurosci
Vital re:Search
Sentara Norfolk General Hospit
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Henry Lahmeyer, MD
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Houston Sleep Center


title: A RANDOMIZED PHASE 2 STUDY OF THE ANTI-ANGIOGENESIS AGENT AG-013736 IN COMBINATION WITH GEMCITABINE IN PATIENTS WITH CHEMOTHERAPY-NAIVE ADVANCED PANCREATIC CANCER PRECEDED BY A PHASE 1 PORTION

summary: This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanced disease. The purpose of the study is to test whether the angiogenesis inhibitor Axitinib [AG-013736] in combination with gemcitabine is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall survival.

ReferenceCitation: Spano JP, Chodkiewicz C, Maurel J, Wong R, Wasan H, Barone C, Letourneau R, Bajetta E, Pithavala Y, Bycott P, Trask P, Liau K, Ricart AD, Kim S, Rixe O. Efficacy of gemcitabine plus axitinib compared with gemcitabine alone in patients with advanced pancreatic cancer: an open-label randomised phase II study. Lancet. 2008 Jun 21;371(9630):2101-8. doi: 10.1016/S0140-6736(08)60661-3. Epub 2008 May 29.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Germany
Italy
United Kingdom
Belgium
United States
Spain
Canada
France

location_facility: Piedmont Hematology Oncology Association

location_facility: Unita Operativa, Oncologia Medica, Istituto di Medicina Interna e Geriatria

location_facility: East Bay Medical Oncology/Hematology Medical Associates, Inc.

location_facility: Maine Center for Cancer Medicine and Blood Disorders

location_facility: Universitair Ziekenhuis Gent/Dienst Gastroenterologie

location_facility: Medizinische Klinik mit Schwerpunkt Haematologie und Onkologie, Charité-Universitaetsmedizin Berlin

location_facility: Department of Cancer Studies & Molecular Medicine

location_facility: H Lee Moffitt Cancer Center & Research Institute

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: East Bay Medical Oncology/Hematology Medical Associates Inc.

location_facility: Fondazione IRCCS, Istituto Nazionale Tumori, Oncologia Medica B

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Arch Medical Services, Inc. d/b/a The Center for Cancer Care and Research

location_facility: Southeast Nebraska Cancer Center, Southeast Nebraska Hematology and Oncology Consultants, P.C.


title: A Multicenter Open-Label Continuation Study in Moderate to Severe Chronic Plaque Psoriasis Subjects Who Completed a Preceding Psoriasis Clinical Study With Adalimumab

summary: The two objectives of this study were to evaluate long-term efficacy and safety of adalimumab treatment in participants who had moderate to severe chronic plaque psoriasis and to evaluate the effectiveness of adalimumab retreatment in participants who had therapeutic response to adalimumab and were then withdrawn from adalimumab treatment.

ReferenceCitation: Gordon K, Papp K, Poulin Y, Gu Y, Rozzo S, Sasso EH. Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: results from an open-label extension study for patients from REVEAL. J Am Acad Dermatol. 2012 Feb;66(2):241-51. doi: 10.1016/j.jaad.2010.12.005. Epub 2011 Jul 14.

ReferenceCitation: Papp K, Crowley J, Ortonne JP, Leu J, Okun M, Gupta SR, Gu Y, Langley RG. Adalimumab for moderate to severe chronic plaque psoriasis: efficacy and safety of retreatment and disease recurrence following withdrawal from therapy. Br J Dermatol. 2011 Feb;164(2):434-41. doi: 10.1111/j.1365-2133.2010.10139.x.

lead_sponsor: Abbott

location_country:
Germany
Poland
Switzerland
Austria
Belgium
United States
Spain
Canada
Puerto Rico
France

location_facility:
Site Reference ID/Investigator#1641
Site Reference ID/Investigator# 1260
Site Reference ID/Investigator# 1674
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Site Reference ID/Investigator# 1258
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Site Reference ID/Investigator# 93
Site Reference ID/Investigator# 1802
Site Reference ID/Investigator# 94


title: A Retrospective Study to Describe the Incidence of Moderate to Severe Allergic Reactions to Factor IX in Patients With Hemophilia B

summary:
Retrospective, multicenter study in patients with hemophilia B. This study will be placed at 20 to 50 hemophilia treatment centers in North America and the EU, and is designed to estimate the frequency of Class II and III allergic reactions in association with the administration of any FIX concentrate.

Following informed consent and eligibility, historical patient information including demographics, allergy history, hemophilia history, frequency and severity of allergic reaction(s), number of exposure days with products causing allergic reactions, exposure days to blood products including FIX concentrates, treatment for allergic reaction(s), outcome of event(s), any other adverse event(s) occuring within 48 hours of onset of allergic reaction(s), rechallenge and outcome, switch to another FIX product (if applicable) and outcome, current status of patient, and results of any special studies (eg, skin or RAST testing, alloantibody analyses, ect) will be collected.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Germany
Italy
United Kingdom
Austria
Belgium
United States
Spain
Canada
France


title: Long-Term, Open Label Safety Study of Atomoxetine Hydrochloride in Patients, 6 Years and Older With Attention-Deficit/Hyperactivity Disorder

summary:
To learn about the safety and any side effects of atomoxetine when given to children and adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who take the drug for about 5 years (long-term).

Study participants can be atomoxetine naive, atomoxetine experienced whose therapy has been interrupted or, atomoxetine experienced on a known stable dose.

ReferenceCitation: Michelson D, Read HA, Ruff DD, Witcher J, Zhang S, McCracken J. CYP2D6 and clinical response to atomoxetine in children and adolescents with ADHD. J Am Acad Child Adolesc Psychiatry. 2007 Feb;46(2):242-51. doi: 10.1097/01.chi.0000246056.83791.b6.

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Italy
Israel
Norway
United Kingdom
Australia
Sweden
Netherlands
Belgium
United States
South Africa
Canada
Puerto Rico
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: A Double-Blind, Randomized, Multicenter, Placebo-controlled, In-Patient, Maximum 34 Day Study of Levetiracetam Oral Solution (20-50 mg/kg/Day) as Adjunctive Treatment of Refractory Partial Onset Seizures in Pediatric Epileptic Subjects Ranging in Age From 1 Month to Less Than 4 Years of Age

summary: To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in pediatric subjects age 1 month to less than 4 years with partial onset seizures. Subjects will be evaluated with 48 hour inpatient video electroencephalograms (a selection and an evaluation). Other neuropsychological clinical assessments will be performed during the 34 day length of the study.

ReferenceCitation: Pina-Garza JE, Nordli DR Jr, Rating D, Yang H, Schiemann-Delgado J, Duncan B; Levetiracetam N01009 Study Group. Adjunctive levetiracetam in infants and young children with refractory partial-onset seizures. Epilepsia. 2009 May;50(5):1141-9. doi: 10.1111/j.1528-1167.2008.01981.x. Epub 2009 Feb 21.

ReferenceCitation: Pina-Garza JE, Schiemann-Delgado J, Yang H, Duncan B, Hadac J, Hunter SJ. Adjunctive levetiracetam in patients aged 1 month to <4 years with partial-onset seizures: subpopulation analysis of a prospective, open-label extension study of up to 48 weeks. Clin Ther. 2010 Oct;32(11):1935-50. doi: 10.1016/j.clinthera.2010.09.017.

lead_sponsor: UCB Pharma

location_country:
Germany
Italy
Poland
Hungary
Argentina
Romania
United Kingdom
Brazil
Mexico
Belgium
United States
Czechia
Canada
Russian Federation
France


title: An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670)in β-thalassemia Patients With Transfusional Iron Overload

summary:
A 1-year randomized Phase III core trial (NCT00061750) using deferoxamine as the comparator was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older. Patients who successfully completed this main trial may continue in this extension trial to receive chelation therapy with deferasirox for an additional 4 years.

The objective of this study is to assess the efficacy and long-term safety of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older.

ReferenceCitation: Cappellini MD, Bejaoui M, Agaoglu L, Canatan D, Capra M, Cohen A, Drelichman G, Economou M, Fattoum S, Kattamis A, Kilinc Y, Perrotta S, Piga A, Porter JB, Griffel L, Dong V, Clark J, Aydinok Y. Iron chelation with deferasirox in adult and pediatric patients with thalassemia major: efficacy and safety during 5 years' follow-up. Blood. 2011 Jul 28;118(4):884-93. doi: 10.1182/blood-2010-11-316646. Epub 2011 May 31. Erratum In: Blood. 2011 Nov 3;118(18):5060.

location_country:
Germany
Italy
United Kingdom
Argentina
Brazil
Tunisia
Belgium
United States
Greece
Turkey
Canada
France

location_facility: Children's Hospital and Research Center at Oakland

location_facility: Children's Hospital Boston, Dept of Hematology


title: A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With Half Dose (75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Replacement Surgery. RE-NOVATE (Extended Thromboembolism Prevention After Hip Surgery)

summary: The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.

ReferenceCitation: Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Feuring M, Kreuzer J, Huo M, Friedman RJ. Oral dabigatran etexilate versus enoxaparin for venous thromboembolism prevention after total hip arthroplasty: pooled analysis of two phase 3 randomized trials. Thromb J. 2015 Nov 17;13:36. doi: 10.1186/s12959-015-0067-8. eCollection 2015.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Kurth AA. Efficacy of delayed thromboprophylaxis with dabigatran: pooled analysis. Thromb Res. 2012 Dec;130(6):871-6. doi: 10.1016/j.thromres.2012.08.315. Epub 2012 Sep 17.

ReferenceCitation: Rosencher N, Noack H, Feuring M, Clemens A, Friedman RJ, Eriksson BI. Type of anaesthesia and the safety and efficacy of thromboprophylaxis with enoxaparin or dabigatran etexilate in major orthopaedic surgery: pooled analysis of three randomized controlled trials. Thromb J. 2012 Jun 18;10(1):9. doi: 10.1186/1477-9560-10-9.

ReferenceCitation: Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Prins MH, Hettiarachchi R, Hantel S, Schnee J, Buller HR; RE-NOVATE Study Group. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007 Sep 15;370(9591):949-56. doi: 10.1016/S0140-6736(07)61445-7. Erratum In: Lancet. 2007 Dec 15;370(9604):2004.

location_country:
Finland
France
Germany
Italy
Poland
Hungary
Norway
Denmark
Australia
Sweden
Netherlands
Austria
Belgium
Spain
South Africa
Czech Republic

location_facility: 1160.48.02701 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03607 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42005 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04812 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04304 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03410 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03902 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04605 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04602 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04607 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04609 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04808 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04571 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.35803 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04807 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42001 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03411 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03901 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04907 Johannes Gutenberg-Universität Mainz

location_facility: 1160.48.04303 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03303 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42007 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04912 Orthopädische Klinik Markgröningen gGmbH

location_facility: 1160.48.04610 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03603 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04804 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04810 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04608 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04702 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03403 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03202 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04817 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03302 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.02702 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.35802 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03104 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04814 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04706 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.02704 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03101 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42004 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04701 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03903 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03602 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03604 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04820 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42003 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03606 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04802 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04301 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04806 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42002 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03401 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03402 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.35801 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04703 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.02703 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03408 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03404 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03102 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04803 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42008 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42006 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04573 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03409 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04704 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03904 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03605 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04302 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03308 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42010 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03304 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04606 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04604 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.06111 Haemophillia & Thrombosis Service

location_facility: 1160.48.03103 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04570 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.35805 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04575 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03107 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04603 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04707 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04801 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03406 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03105 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.35804 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04915 Orthopädische Klinik Lindenlohe

location_facility: 1160.48.03407 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03405 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42009 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04574 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03601 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04601 Boehringer Ingelheim Investigational Site


title: A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010 Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols.

summary: The purpose of this study was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. In addition, this study will continue to follow patients who have taken ipilimumab, but who are not eligible for maintenance or reinduction therapy.

ReferenceCitation: Lebbe C, Weber JS, Maio M, Neyns B, Harmankaya K, Hamid O, O'Day SJ, Konto C, Cykowski L, McHenry MB, Wolchok JD. Survival follow-up and ipilimumab retreatment of patients with advanced melanoma who received ipilimumab in prior phase II studies. Ann Oncol. 2014 Nov;25(11):2277-2284. doi: 10.1093/annonc/mdu441. Epub 2014 Sep 10.

oa_colors: green hybrid

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

repositories_concat: PubMed Central;usiena-air.unisi.it

unpaywall_oa_status: hybrid

lead_sponsor: Bristol-Myers Squibb

location_country:
France
Germany
Italy
Poland
Israel
Argentina
Denmark
Norway
Brazil
Austria
Belgium
United States
Spain
South Africa
Canada
Ukraine
Russian Federation
Czech Republic

location_facility: Joe Arrington Cancer Research And Treatment Center

location_facility: Center For Oncology Research & Treatment, P.A.

location_facility: The Christ Hospital Cancer Center Research

location_facility: Washington University School Of Medicine


title: The Prolongation of the EPAAC™ Trial - NCT00152464 (The Early Prevention of Asthma in Atopic Children). A Multi-country, Double Blind, Placebo (PLC) Controlled, Follow-up Trial With 3 Parallel Groups (LCTZ-LCTZ, LCTZ-PLC and PLC-PLC) : Evaluation of the Long Term Efficacy and Safety of Levocetirizine (LCTZ) (5 mg/ml Oral Drops -0.125 mg/kg b.w. b.i.d.) Administered for an Additional 18 Months Period in Preventing the Onset of Asthma in Children Coming From the EPAAC Trial.

summary:
Prolongation of the EPAAC™ trial - NCT00152464 (The Early Prevention of Asthma in Atopic Children).

36 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in young atopic children.

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Belgium
Spain
South Africa
Czech Republic
France


title: Clinical Protocol For a Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Celecoxib (SC-58635) In The Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

acronym: PRESAP

summary: This study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial to compare the efficacy and safety of celecoxib 400mg QD versus placebo in reducing the occurrence of new colorectal adenomas post-polypectomy at Month 13 (Year 1) and Month 37 (Year 3) of study drug administration.

ReferenceCitation: Arber N, Lieberman D, Wang TC, Zhang R, Sands GH, Bertagnolli MM, Hawk ET, Eagle C, Coindreau J, Zauber A, Lanas A, Levin B. The APC and PreSAP trials: a post hoc noninferiority analysis using a comprehensive new measure for gastrointestinal tract injury in 2 randomized, double-blind studies comparing celecoxib and placebo. Clin Ther. 2012 Mar;34(3):569-79. doi: 10.1016/j.clinthera.2012.02.001. Epub 2012 Mar 2.

ReferenceCitation: Arber N, Spicak J, Racz I, Zavoral M, Breazna A, Gerletti P, Lechuga MJ, Collins N, Rosenstein RB, Eagle CJ, Levin B. Five-year analysis of the prevention of colorectal sporadic adenomatous polyps trial. Am J Gastroenterol. 2011 Jun;106(6):1135-46. doi: 10.1038/ajg.2011.116. Epub 2011 Apr 19.

ReferenceCitation: Solomon SD, Wittes J, Finn PV, Fowler R, Viner J, Bertagnolli MM, Arber N, Levin B, Meinert CL, Martin B, Pater JL, Goss PE, Lance P, Obara S, Chew EY, Kim J, Arndt G, Hawk E; Cross Trial Safety Assessment Group. Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis. Circulation. 2008 Apr 22;117(16):2104-13. doi: 10.1161/CIRCULATIONAHA.108.764530. Epub 2008 Mar 31.

ReferenceCitation: Arber N, Eagle CJ, Spicak J, Racz I, Dite P, Hajer J, Zavoral M, Lechuga MJ, Gerletti P, Tang J, Rosenstein RB, Macdonald K, Bhadra P, Fowler R, Wittes J, Zauber AG, Solomon SD, Levin B; PreSAP Trial Investigators. Celecoxib for the prevention of colorectal adenomatous polyps. N Engl J Med. 2006 Aug 31;355(9):885-95. doi: 10.1056/NEJMoa061652.

ReferenceCitation: Solomon SD, Pfeffer MA, McMurray JJ, Fowler R, Finn P, Levin B, Eagle C, Hawk E, Lechuga M, Zauber AG, Bertagnolli MM, Arber N, Wittes J; APC and PreSAP Trial Investigators. Effect of celecoxib on cardiovascular events and blood pressure in two trials for the prevention of colorectal adenomas. Circulation. 2006 Sep 5;114(10):1028-35. doi: 10.1161/CIRCULATIONAHA.106.636746.

location_country:
Finland
Germany
Ireland
Poland
Australia
Brazil
Chile
Canada
France
Czech Republic
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Belgium
China
Peru
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Uruguay
Spain
South Africa
Taiwan
Russian Federation
Israel


title: Double-Blind Parallel-Group Randomized Study Of Efficacy And Safety Of "Continuous Use" Of Celecoxib Vs. The "Usual Use" Of Celecoxib In The Treatment Of Subjects With Chronic Osteoarthritis Of The Hip Or Knee Who Require an Anti-inflammatory Medication for Control Of Their Pain

summary: To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee and hip.

ReferenceCitation: Strand V, Simon LS, Dougados M, Sands GH, Bhadra P, Breazna A, Immitt J. Treatment of osteoarthritis with continuous versus intermittent celecoxib. J Rheumatol. 2011 Dec;38(12):2625-34. doi: 10.3899/jrheum.110636. Epub 2011 Nov 1.

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

location_country:
Colombia
United Kingdom
Brazil
Belgium
United States
Chile
Canada
France


title: A Double-Blind, Placebo-Controlled, Multicenter Phase IIb Extension Study to Evaluate the Safety and Efficacy of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

summary:
Study SB-767905/008 was a multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in participants with cancer pain.

Study ABD101684 will serve as an extension to Study SB-767905/008 and offer continued access to blinded investigational product to participants who have completed the original study. The purpose of Study ABD101684 is to evaluate the safety and efficacy of alvimopan compared to placebo in subjects who completed Study SB-767905/008 and elected to participate in this extension study.

lead_sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

location_country:
Finland
Poland
Portugal
New Zealand
United Kingdom
Hong Kong
United States
Spain
Pakistan
Peru
Canada
Russian Federation
France


title: Open Label, Dose Escalation, Followed by Open Label,Single Arm Clinical Trial of HuMax-CD4 in Patients With Mycosis Fungoides Type CTCL (Stage IB-IVB) or Sezary Syndrome Who Are Refractory or Intolerant to Targretin® (Bexarotene) and One Other Standard Therapy

summary: The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.

lead_sponsor: Emergent Product Development Seattle LLC

location_country:
Germany
Italy
United States
Spain
France

location_facility: University of Milan-Fondazione IRCCS di Natura Pubblica Ospedale Maggiore Policlinico Mangiagalli e Regina Elena di Milano via Francesco Sforza

location_facility: University of Essen - Universitatsklinikum Essen z. Hd. Frau Desire Zieling

location_facility: University of Turin SCDU Dermosifilopatia 2 A.S.O. Molinette S.Giovanni Battista

location_facility: Instituto di Ematologia e Oncologia Medica "L. & A. Seragnoli"

location_facility: University of kiel, Klinik Fur Dermotologie, Christian-Albrechts-Universitat Zu

location_facility: Consultation Dermatologie Niveau moins 1 Hopital Archet 2

location_facility: Day Hospital Oncologico-Presidio Ospedaliero Firenze Centro Ospedale Santa Maria Nuova Azienda Sanitaria di Firenze, University of Florence

location_facility: Maternidad Planta Baja, Hospital 12 de Octubre

location_facility: Skin Cancer Center Charite Mitte Dermatologie Fran Ramona Kursawa

location_facility: Instituto Dermopatico dell'Immacolata IRCCS via Monti di Creta

location_facility: University of Wurzburg - Universitatsklinikum Wurzburg dermato-onkologische studien

location_facility: Centre Hospitalier Lyon Sud Bat. 1F 1er etage service Hematologie

location_facility: University of Pennsylvania Health System

location_facility: Hopital Saint-Louis Service de Dermatologie


title: A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate

summary: This is a world wide study to evaluate the remission and joint damage in subjects treated with abatacept in addition to methotrexate versus subjects who receive methotrexate along with a placebo.

ReferenceCitation: Durez P, Westhovens R, Baeke F, Elbez Y, Robert S, Ahmad HA. Identification of poor prognostic joint locations in an early rheumatoid arthritis cohort at risk of rapidly progressing disease: a post-hoc analysis of the Phase III AGREE study. BMC Rheumatol. 2022 Apr 14;6(1):24. doi: 10.1186/s41927-022-00252-4.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

ReferenceCitation: Jansen DTSL, Emery P, Smolen JS, Westhovens R, Le Bars M, Connolly SE, Ye J, Toes REM, Huizinga TWJ. Conversion to seronegative status after abatacept treatment in patients with early and poor prognostic rheumatoid arthritis is associated with better radiographic outcomes and sustained remission: post hoc analysis of the AGREE study. RMD Open. 2018 Mar 30;4(1):e000564. doi: 10.1136/rmdopen-2017-000564. eCollection 2018.

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via OAI-PMH title and first author match)

repositories_concat: PubMed Central;eprints.whiterose.ac.uk

publisher_dissemination: British Medical Journal

ReferenceCitation: Smolen JS, Wollenhaupt J, Gomez-Reino JJ, Grassi W, Gaillez C, Poncet C, Le Bars M, Westhovens R. Attainment and characteristics of clinical remission according to the new ACR-EULAR criteria in abatacept-treated patients with early rheumatoid arthritis: new analyses from the Abatacept study to Gauge Remission and joint damage progression in methotrexate (MTX)-naive patients with Early Erosive rheumatoid arthritis (AGREE). Arthritis Res Ther. 2015 Jun 11;17(1):157. doi: 10.1186/s13075-015-0671-9.

oa_host_type: repository

unpaywall_oa_status: green

ReferenceCitation: Bathon J, Robles M, Ximenes AC, Nayiager S, Wollenhaupt J, Durez P, Gomez-Reino J, Grassi W, Haraoui B, Shergy W, Park SH, Genant H, Peterfy C, Becker JC, Covucci A, Moniz Reed D, Helfrick R, Westhovens R. Sustained disease remission and inhibition of radiographic progression in methotrexate-naive patients with rheumatoid arthritis and poor prognostic factors treated with abatacept: 2-year outcomes. Ann Rheum Dis. 2011 Nov;70(11):1949-56. doi: 10.1136/ard.2010.145268. Epub 2011 Aug 6.

location_country:
France
Germany
Italy
Poland
United Kingdom
Australia
Brazil
Netherlands
Mexico
Belgium
United States
Korea, Republic of
Spain
South Africa
Canada
Puerto Rico
Russian Federation
Czech Republic

location_facility: Rheumatology Associates Of North Alabama

location_facility: Arthritis Assoc And Osteo Ctr Of Col Sprgs

location_facility: Arthritis Clinic Of Northern Virginia, P.C.


title: A Phase III, 18 Month, Multicenter, Randomized, Double-Blind, Active-Controlled Clinical Trial to Compare Rosiglitazone Versus Glipizide on the Progression of Atherosclerosis in Subjects With Type 2 Diabetes Mellitus and Cardiovascular Disease (APPROACH)

summary: The purpose of this study is to test the safety and effectiveness of rosiglitazone against a sulfonylurea in reducing or slowing the development of atherosclerosis in the blood vessels of the heart.

ReferenceCitation: Garcia-Garcia HM, Garg S, Brugaletta S, Morocutti G, Ratner RE, Kolatkar NS, Kravitz BG, Miller DM, Huang C, Nesto RW, Serruys PW; APPROACH study group. Evaluation of in-stent restenosis in the APPROACH trial (Assessment on the Prevention of Progression by Rosiglitazone On Atherosclerosis in diabetes patients with Cardiovascular History). Int J Cardiovasc Imaging. 2012 Mar;28(3):455-65. doi: 10.1007/s10554-011-9836-z. Epub 2011 Feb 27.

ReferenceCitation: Gerstein HC, Ratner RE, Cannon CP, Serruys PW, García-García HM, van Es G-A, Kolatkar NS, Kravitz BG, Miller DM, Huang C, Fitzgerald PJ, Nesto RW; APPROACH study group. Effect of Rosiglitazone on Progression of Coronary Atherosclerosis in Patients with Type 2 Diabetes and Coronary Artery Disease: The APPROACH trial. (Submitted for publication).

ReferenceCitation: Nesto RW. Effect of rosiglitazone versus glipizide on progression of coronary atherosclerosis in patients with type 2 diabetes and coronary artery disease. American Heart Association Scientific Sessions. November 12, 2008, New Orleans, LA. (http://directnews.americanheart.org/extras/pdfs/approach_slides.pdf)

ReferenceCitation: Ratner RE, Cannon CP, Gerstein HC, Nesto RW, Serruys PW, Van Es GA, Kolatkar NS, Kravitz BG, Zalewski A, Fitzgerald PJ; APPROACH Study Group. Assessment on the Prevention of Progression by Rosiglitazone on Atherosclerosis in diabetes patients with Cardiovascular History (APPROACH): study design and baseline characteristics. Am Heart J. 2008 Dec;156(6):1074-9. doi: 10.1016/j.ahj.2008.07.025. Epub 2008 Oct 11.

ReferenceCitation: Gerstein HC, Ratner RE, Cannon CP, Serruys PW, Garcia-Garcia HM, van Es GA, Kolatkar NS, Kravitz BG, Miller DM, Huang C, Fitzgerald PJ, Nesto RW; APPROACH Study Group. Effect of rosiglitazone on progression of coronary atherosclerosis in patients with type 2 diabetes mellitus and coronary artery disease: the assessment on the prevention of progression by rosiglitazone on atherosclerosis in diabetes patients with cardiovascular history trial. Circulation. 2010 Mar 16;121(10):1176-87. doi: 10.1161/CIRCULATIONAHA.109.881003. Epub 2010 Mar 1.

location_country:
Germany
Poland
Argentina
Brazil
Thailand
Canada
France
Czech Republic
Hong Kong
United States
Latvia
India
Italy
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Russian Federation
Sweden


title: A Phase IIb Randomized, Partially Blinded, Dose-Finding Trial of TMC278 in Antiretroviral-Naive HIV-1 Infected Subjects

summary: The purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278.

ReferenceCitation: Pozniak AL, Morales-Ramirez J, Katabira E, Steyn D, Lupo SH, Santoscoy M, Grinsztejn B, Ruxrungtham K, Rimsky LT, Vanveggel S, Boven K; TMC278-C204 Study Group. Efficacy and safety of TMC278 in antiretroviral-naive HIV-1 patients: week 96 results of a phase IIb randomized trial. AIDS. 2010 Jan 2;24(1):55-65. doi: 10.1097/QAD.0b013e32833032ed.

lead_sponsor: Tibotec Pharmaceuticals, Ireland

location_country:
Germany
Uganda
United Kingdom
Argentina
Brazil
Austria
Mexico
United States
China
Thailand
South Africa
Puerto Rico
Russian Federation
France


title: A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis

summary: This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

ReferenceCitation: Drobinski PJ, Bay-Jensen AC, Karsdal MA, Sardar S, Siebuhr AS. Connective tissue remodelling is differently modulated by tocilizumab versus methotrexate monotherapy in patients with early rheumatoid arthritis: the AMBITION study. Arthritis Res Ther. 2021 Jan 7;23(1):13. doi: 10.1186/s13075-020-02378-7.

repository_institution: Research Square - Research Square

repository_normalized: Research Square

version: submittedVersion

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

repositories_institution:
PubMed Central - Europe PMC
Research Square - Research Square

ReferenceCitation: Strand V, Michalska M, Birchwood C, Pei J, Tuckwell K, Finch R, Gabay C, Kavanaugh A, Jones G. Impact of tocilizumab monotherapy on patient-reported outcomes in patients with rheumatoid arthritis from two randomised controlled trials. RMD Open. 2017 Sep 14;3(2):e000496. doi: 10.1136/rmdopen-2017-000496. eCollection 2017.

repository_institution: University of Geneva - Archive ouverte UNIGE

repository_institution: University of Illinois at Chicago - INDIGO

repository_institution: University of Tasmania - eCite Digital Repository

version: acceptedVersion

ReferenceCitation: Jones G, Wallace T, McIntosh MJ, Brockwell L, Gomez-Reino JJ, Sebba A. Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Methotrexate- and Biologic-naive or Free of Methotrexate for 6 Months: the AMBITION Study. J Rheumatol. 2017 Feb;44(2):142-146. doi: 10.3899/jrheum.160287. Epub 2016 Dec 1.

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: The Journal of Rheumatology

ReferenceCitation: Wang J, Bansal AT, Martin M, Germer S, Benayed R, Essioux L, Lee JS, Begovich A, Hemmings A, Kenwright A, Taylor KE, Upmanyu R, Cutler P, Harari O, Marchini J, Criswell LA, Platt A. Genome-wide association analysis implicates the involvement of eight loci with response to tocilizumab for the treatment of rheumatoid arthritis. Pharmacogenomics J. 2013 Jun;13(3):235-41. doi: 10.1038/tpj.2012.8. Epub 2012 Apr 10.

ReferenceCitation: Jones G, Sebba A, Gu J, Lowenstein MB, Calvo A, Gomez-Reino JJ, Siri DA, Tomsic M, Alecock E, Woodworth T, Genovese MC. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis. 2010 Jan;69(1):88-96. doi: 10.1136/ard.2008.105197.

lead_sponsor: Hoffmann-La Roche

location_country:
Slovenia
Italy
Lithuania
Portugal
Israel
Argentina
Denmark
Australia
Norway
Mexico
United States
China
Spain
South Africa
Peru
Canada
Serbia
France


title: A PhaseIIb, 96 Week, Randomised, Partially Double-blinded, Multicentre, Parallel Group, Repeat Dose Study to Evaluate the Safety, Tolerability, PK and Antiviral Effect of GW873140 in Combination With COMBIVIR (Lamivudine and Zidovudine) Upon Selected Immunological and Virological Markers of HIV-1 Infection in Antiretroviral Therapy Naive Adults

summary: This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Combivir in HIV infected, untreated subjects.

lead_sponsor: ViiV Healthcare

location_country:
Germany
Italy
Portugal
United Kingdom
Belgium
United States
Spain
Canada
France


title: A Long Term, Double-blind, Randomized, Parallel-group, Carbidopa/Levodopa Controlled, Multi-center Study to Evaluate the Effect of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy

acronym: STRIDE-PD

summary: The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.

ReferenceCitation: Stocchi F, Rascol O, Kieburtz K, Poewe W, Jankovic J, Tolosa E, Barone P, Lang AE, Olanow CW. Initiating levodopa/carbidopa therapy with and without entacapone in early Parkinson disease: the STRIDE-PD study. Ann Neurol. 2010 Jul;68(1):18-27. doi: 10.1002/ana.22060. Erratum In: Ann Neurol. 2010 Sep;68(3):412-3.

lead_sponsor: Novartis Pharmaceuticals

sponsor_collaborators:
Novartis Pharmaceuticals
Orion Corporation, Orion Pharma

location_country:
Finland
Germany
Italy
United Kingdom
Sweden
Switzerland
Austria
Belgium
United States
Spain
Greece
Turkey
Canada
France

location_facility: Duke University Medical Center Movement Disorders Center

location_facility: Keck School of Medicine, Division of Movement Disorders

location_facility: Parkinson's Disease and Movement Disorders Center of Long Island

location_facility: Parkinson's Disease and Movement Disorder Center of Albany Medical

location_facility: Columbia University, Neurological Institute

location_facility: Baylor College of Medicine, Parkinson's Disease Center

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Wisconsin Institute for Neurologic and Sleep Disorders


title: The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Patients With Moderate Hypertension

summary: The purpose of this clinical research is to learn if moderate hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.

enrollment_type: Anticipated

sponsor_collaborators:
Bristol-Myers Squibb
Sanofi

location_country:
Germany
United States
Canada
Russian Federation
France


title: A Multicenter Study to Evaluate the Effect of Rituximab (IDEC-102) on Primary Humoral Response, Recall Response, and Maintenance of Acquired Immunity to Specific Antigens

summary: The purpose of this study is to provide treatment for patients who have relapsed Non-Hodgkin's lymphoma (NHL) or refractory NHL, and to test the immunity of study subjects after receiving four treatments with rituximab.

location_country:
Germany
Lithuania
United Kingdom
Romania
Sweden
Austria
United States
Turkey
Czech Republic
Russian Federation
France

location_facility: University of Texas Health Science Center at San Antonio


title: A Phase 3 Multicenter, Open Label, Randomized Study of XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors Not Amenable to Conventional Surgery

summary: The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors.

lead_sponsor: Helsinn Healthcare SA

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Belgium
United States
Spain
Canada
Russian Federation
France

location_facility: University of California, Irvine Medical Center

location_facility: University of Wisconsin Comprehensive Cancer Center

location_facility: Klinikum Grosshadern der Ludwig Maximilians Universitaet

location_facility: Winship Cancer Institute, Emory University Hospital

location_facility: Cancer Research Center named after N.N. Blokhin, RAMS

location_facility: Hospital Clinic i Provincial (Oncology Department)

location_facility: Centre Hospitalier Universite de Montreal

location_facility: University of Alabama at Birmingham Comprehensive Cancer Center

location_facility: Josephine Ford Cancer Center at Henry Ford Health System

location_facility: Medical Consultants, PC c/o Ball Cancer Center

location_facility: Centro di Riferimento Oncologico di Aviano

location_facility: British Columbia Cancer Agency - Vancouver Centre

location_facility: Hospital Regional Universitario Carlos Haya


title: A Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-Controlled Study of Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass (PRIMO-CABG II)

summary: During a heart bypass procedure, a substance called "complement" is activated by the body. This "complement activation" causes an inflammatory response that can lead to side affects such as chest pain, heart attacks, stroke, heart failure, or death. The purpose of this study is to find out if the study drug (pexelizumab), that blocks "complement activation," can reduce such side effects and be given safely to patients requiring the bypass procedure with the use of the heart-lung machine.

ReferenceCitation: Smith PK, Shernan SK, Chen JC, Carrier M, Verrier ED, Adams PX, Todaro TG, Muhlbaier LH, Levy JH; PRIMO-CABG II Investigators. Effects of C5 complement inhibitor pexelizumab on outcome in high-risk coronary artery bypass grafting: combined results from the PRIMO-CABG I and II trials. J Thorac Cardiovasc Surg. 2011 Jul;142(1):89-98. doi: 10.1016/j.jtcvs.2010.08.035. Epub 2010 Sep 28.

lead_sponsor: Alexion Pharmaceuticals, Inc.

sponsor_collaborators:
Alexion Pharmaceuticals, Inc.
Procter and Gamble

location_country:
United States
Netherlands
Germany
France

location_facility: University of Alabama at Birmingham Hospital

location_facility: University of California Irvine Medical Center

location_facility: Shands Hospital at the University of Florida

location_facility: Veterans Administration Greater Los Angeles Healthcare Sysytem

location_facility: Los Angeles County-University of Southern California Medical Center

location_facility: Veterans Administration Palo Alto Healthcare System

location_facility: Kaiser Permanente Moanalua Medical Center

location_facility: West Shore Cardiology Research Department

location_facility: Cooper Health System/University Medical Center

location_facility: University of Colorado Health Sciences Center

location_facility: Michael E. DeBakey Veterans Affairs Medical Center

location_facility: Cooper Hospital University Medical Center

location_facility: Southern Arizona Veterans Affairs Health Care System

location_facility: St. Luke's Episcopal Hospital - Texas Heart

location_facility: University of Southern California University Hospital

location_facility: Zentrum fuer Herzchirurgie der Frederick-Alexander-Universitaet

location_facility: Atlanta Veteran's Administration (VA) Medical Center

location_facility: Veterans Administration (VA) Boston Healthcare System

location_facility: University of North Carolina at Chapel Hill Hospitals

location_facility: Clarian Health Partners, Inc. Methodist Hospital

location_facility: Health First Holmes Regional Medical Center


title: Linezolid In The Treatment Of Subjects With Nosocomial Pneumonia Proven To Be Due To Methicillin-Resistant Staphylococcus Aureus

acronym: ZEPHYR

summary: To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (MRSA) in adult subjects. Subjects entered in to the study will have proven healthcare-associated methicillin-resistant Staphylococcus aureus pneumonia which will be treated with either linezolid or vancomycin.

ReferenceCitation: Equils O, da Costa C, Wible M, Lipsky BA. The effect of diabetes mellitus on outcomes of patients with nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus: data from a prospective double-blind clinical trial comparing treatment with linezolid versus vancomycin. BMC Infect Dis. 2016 Sep 6;16(1):476. doi: 10.1186/s12879-016-1779-5.

ReferenceCitation: Shorr AF, Puzniak LA, Biswas P, Niederman MS. Predictors of Clinical Success in the Treatment of Patients with Methicillin-Resistant Staphylococcus aureus (MRSA) Nosocomial Pneumonia (NP). PLoS One. 2015 Jul 21;10(7):e0131932. doi: 10.1371/journal.pone.0131932. eCollection 2015.

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Public Library of Science

ReferenceCitation: Quartin AA, Scerpella EG, Puttagunta S, Kett DH. A comparison of microbiology and demographics among patients with healthcare-associated, hospital-acquired, and ventilator-associated pneumonia: a retrospective analysis of 1184 patients from a large, international study. BMC Infect Dis. 2013 Nov 27;13:561. doi: 10.1186/1471-2334-13-561.

publisher_dissemination: Springer

ReferenceCitation: Puzniak LA, Morrow LE, Huang DB, Barreto JN. Impact of weight on treatment efficacy and safety in complicated skin and skin structure infections and nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus. Clin Ther. 2013 Oct;35(10):1557-70. doi: 10.1016/j.clinthera.2013.08.001. Epub 2013 Sep 3.

lead_sponsor: Pfizer

location_country:
Germany
Poland
Argentina
Brazil
Turkey
Chile
France
Colombia
Portugal
Hong Kong
United States
Belgium
Malaysia
Puerto Rico
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation


title: A Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome

summary: The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).

ReferenceCitation: Dudrick SJ, Latifi R, Fosnocht DE. Management of the short-bowel syndrome. Surg Clin North Am. 1991 Jun;71(3):625-43. doi: 10.1016/s0039-6109(16)45438-1.

ReferenceCitation: Rombeau JL, Rolandelli RH. Enteral and parenteral nutrition in patients with enteric fistulas and short bowel syndrome. Surg Clin North Am. 1987 Jun;67(3):551-71. doi: 10.1016/s0039-6109(16)44232-5.

ReferenceCitation: Shanbhogue LK, Molenaar JC. Short bowel syndrome: metabolic and surgical management. Br J Surg. 1994 Apr;81(4):486-99. doi: 10.1002/bjs.1800810404.

ReferenceCitation: Vanderhoof JA, Langnas AN. Short-bowel syndrome in children and adults. Gastroenterology. 1997 Nov;113(5):1767-78. doi: 10.1053/gast.1997.v113.pm9352883.

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: Fujioka K, Jeejeebhoy K, Pape UF, Li B, Youssef NN, Schneider SM. Patients With Short Bowel on Narcotics During 2 Randomized Trials Have Abdominal Complaints Independent of Teduglutide. JPEN J Parenter Enteral Nutr. 2017 Nov;41(8):1419-1422. doi: 10.1177/0148607116663481. Epub 2016 Aug 9.

publisher_dissemination: Wiley

lead_sponsor: Shire

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

location_facility: University of Pennsylvania - Penn Nursing

location_facility: Rigshospitalet, University of Copenhagen

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

location_facility: Northwestern Center for Clinical Research


title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis

summary: Clinical and experimental studies suggest that bosentan could delay the progression of interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a condition for which no established efficacious treatment is available. The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO Class III and IV, to a new category of patients suffering from ILD associated with SSc.

ReferenceCitation: Liu C, Chen J, Gao Y, Deng B, Liu K. Endothelin receptor antagonists for pulmonary arterial hypertension. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD004434. doi: 10.1002/14651858.CD004434.pub6.

ReferenceCitation: Seibold JR, Denton CP, Furst DE, Guillevin L, Rubin LJ, Wells A, Matucci Cerinic M, Riemekasten G, Emery P, Chadha-Boreham H, Charef P, Roux S, Black CM. Randomized, prospective, placebo-controlled trial of bosentan in interstitial lung disease secondary to systemic sclerosis. Arthritis Rheum. 2010 Jul;62(7):2101-8. doi: 10.1002/art.27466. Erratum In: Arthritis Rheum. 2010 Oct;62(10):3005.

lead_sponsor: Actelion

location_country:
Germany
Italy
France
United Kingdom
Sweden
Netherlands
Switzerland
United States
Israel

location_facility: University of Illinois College of Medicine

location_facility: University of Texas Houston Medical School