title: A Multicenter Prospective Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of the Aperius™ PercLID™ System Versus Standalone Decompressive Surgery in Degenerative Lumbar Spinal Stenosis With Neurogenic Intermittent Claudication

acronym: NICE

summary: The objective of the NICE study is to provide clinical evidence proving that the Aperius™ PercLID™ System is safe and non-inferior to standalone decompressive surgery with regards to clinical outcomes in patients suffering from Degenerative Lumbar Spinal Stenosis with Neurogenic Intermittent Claudication, relieved by flexion.

lead_sponsor: Medtronic Spinal and Biologics

location_country:
Poland
Belgium
United Kingdom
Italy
Australia
Sweden
France
Singapore
Iceland
Germany

location_facility: Landspitali - National hospital of Iceland

location_facility: Szpital Kliniczny Dziecatka Jezus - Orthopaedics

location_facility: Azienda Ospedaliera Sant'Andrea - Neurochirurgia

location_facility: Woodend Hospital - Department of Orthopaedics

location_facility: CHU de Nice Hôpital Pasteur - Neurochirurgie

location_facility: Centre hospitalier du Grand Hornu - Orthopédie / Traumatologie

location_facility: Centre Universitaire Pellegrin Tripode -Orthopédie-Traumatologie

location_facility: Neurochirurgische Klinik - Campus Benjamin Franklin

location_facility: Ospedale di Circolo - Ortopedia e Traumatologia

location_facility: Singapore General Hospital - Orthopaedic Surgery

location_facility: Klinikum rechts der Isar der TU München - Neurochirurgie

location_facility: Hôpital Roger Salengro - Clinique de Neurochirurgie


title: A Double-blind, Randomized, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Macitentan in Patients With Idiopathic Pulmonary Fibrosis

acronym: MUSIC

summary:
The AC-055B201/MUSIC study is a Phase II study, comparing one dose of ACT-064922 (macitentan) 10 mg with placebo in patients with idiopathic pulmonary fibrosis (IPF). The main study objective is to demonstrate that macitentan positively affects the forced vital capacity (FVC) in comparison with placebo in patients with idiopathic pulmonary fibrosis (IPF).

The secondary objectives are to evaluate the effect of macitentan on the time to disease worsening or death in patients with IPF, and to evaluate the benefit/risk profile of macitentan in the treatment of patients with IPF.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Raghu G, Million-Rousseau R, Morganti A, Perchenet L, Behr J; MUSIC Study Group. Macitentan for the treatment of idiopathic pulmonary fibrosis: the randomised controlled MUSIC trial. Eur Respir J. 2013 Dec;42(6):1622-32. doi: 10.1183/09031936.00104612. Epub 2013 May 16.

lead_sponsor: Actelion

location_country:
Slovenia
Italy
Spain
Australia
Canada
Sweden
United States
France
Israel
Turkey
South Africa
Germany

location_facility: Baylor College of Medicine - Baylor Clinic

location_facility: CHRU - Hopital Calmette Clinique des Maladies Respiratoires

location_facility: Università degli Studi di Torino Clinica di Malattie dell'Apparato Respiratorio

location_facility: Stanford University Medical Center - Chest Clinic

location_facility: National Jewish Medical & Research Center

location_facility: Hôpital Cardiologique et Pneumologique Louis Pradel

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Centre for Chest Diseases, Milpark Hospital

location_facility: Temple University Hospital - Lung Center

location_facility: University of Alberta - Health Sciences Center

location_facility: Karolinska Universitetssjukhuset Lung Allergi kliniken

location_facility: University of California - San Francisco

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: TMC125-TiDP2-C238: A Randomized, Exploratory, Open-label 48-week Trial to Investigate the Pharmacokinetics, Safety, Tolerability and Antiviral Activity of Etravirine (ETR) in Combination With Ritonavir-boosted Atazanavir (ATV/Rtv) and 1 NRTI in Treatment-experienced HIV-1 Infected Subjects

summary: The purpose of this study is to determine the pharmacokinetics (how the body absorbs, distributes, metabolizes and eliminates a drug) (PK) of ETR when given with ATV/rtv and 1 NRTI in treatment experienced HIV-1 infected patients. In addition, safety, tolerability and anti-HIV effect of this regimen will also be studied. A total of 46 patients will be enrolled.

lead_sponsor: Janssen R&D Ireland

location_country:
Argentina
Thailand
United States
France
South Africa


title: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension

summary:
This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur at 4 week intervals for 16 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests.

Patients who complete all assessments for 16-weeks will also be eligible to enter an open-label, extension phase study (FREEDOM - EXT).

ReferenceCitation: Richter MJ, Schermuly R, Seeger W, Rao Y, Ghofrani HA, Gall H. Relevance of angiopoietin-2 and soluble P-selectin levels in patients with pulmonary arterial hypertension receiving combination therapy with oral treprostinil: a FREEDOM-C2 biomarker substudy. Pulm Circ. 2016 Dec;6(4):516-523. doi: 10.1086/688671.

ReferenceCitation: Tapson VF, Jing ZC, Xu KF, Pan L, Feldman J, Kiely DG, Kotlyar E, McSwain CS, Laliberte K, Arneson C, Rubin LJ; FREEDOM-C2 Study Team. Oral treprostinil for the treatment of pulmonary arterial hypertension in patients receiving background endothelin receptor antagonist and phosphodiesterase type 5 inhibitor therapy (the FREEDOM-C2 study): a randomized controlled trial. Chest. 2013 Sep;144(3):952-958. doi: 10.1378/chest.12-2875.

lead_sponsor: United Therapeutics

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

location_facility: Pulmonology Department Rambam Medical Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: Vancouver Coastal Health Respiratory Clinic

location_facility: Columbia University Presbyterian Medical Center

location_facility: University of Colorado Health Science Center

location_facility: Mary M Parkes Center for Asthma, Allergy and Pulmonary Care

location_facility: Pulmonary Critical Care Medicine, Brigham and Women's Hospital

location_facility: The University of Texas Health Science Center at Houston

location_facility: University of California, San Francisco-Fresno

location_facility: University Hospitals Case Medical Center


type: Registry Identifier

title: Phase III Intergroup Study of Radiotherapy With Concomitant and Adjuvant Temozolomide Versus Radiotherapy With Adjuvant PCV Chemotherapy in Patients With 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

summary: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

study_start_date_type: Actual

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Cerhan JH, Anderson SK, Butts AM, Porter AB, Jaeckle K, Galanis E, Brown PD. Examiner accuracy in cognitive testing in multisite brain-tumor clinical trials: an analysis from the Alliance for Clinical Trials in Oncology. Neurooncol Pract. 2019 Jul;6(4):283-288. doi: 10.1093/nop/npy048. Epub 2018 Nov 24.

ReferenceCitation: Drappatz J, Lieberman F. Chemotherapy of Oligodendrogliomas. Prog Neurol Surg. 2018;31:152-161. doi: 10.1159/000467376. Epub 2018 Jan 25.

lead_sponsor: Alliance for Clinical Trials in Oncology

location_country:
Austria
Canada
United States
France
Belgium
Netherlands

location_facility: Southeast Nebraska Cancer Center - 68th Street Place

location_facility: Sutter Cancer Centers Radiation Oncology Services-Cameron Park

location_facility: Washington University School of Medicine

location_facility: Radiation Oncology Centers of Nevada Southeast

location_facility: Virginia Commonwealth University/Massey Cancer Center

location_facility: University of Pittsburgh Cancer Institute (UPCI)

location_facility: Ottawa Hospital and Cancer Center-General Campus

location_facility: Saint Alphonsus Cancer Care Center-Caldwell

location_facility: University of Chicago Comprehensive Cancer Center

location_facility: Cleveland Clinic Wooster Family Health and Surgery Center

location_facility: Saint Luke's University Hospital-Bethlehem Campus

location_facility: University of Kansas Cancer Center - Lee's Summit

location_facility: Radiation Oncology Centers of Nevada Central

location_facility: State University of New York Upstate Medical University

location_facility: Walter Reed National Military Medical Center

location_facility: University of Kentucky/Markey Cancer Center

location_facility: OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Sutter Cancer Centers Radiation Oncology Services-Roseville

location_facility: Legacy Good Samaritan Hospital and Medical Center

location_facility: Massachusetts General Hospital Cancer Center

location_facility: University of Kansas Hospital-Westwood Cancer Center

location_facility: University of Kansas Cancer Center - North

location_facility: Huntsman Cancer Institute/University of Utah

location_facility: NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

location_facility: Memorial Regional Cancer Center Day Road

location_facility: University of Kansas Cancer Center-Overland Park

location_facility: Prisma Health Cancer Institute - Eastside

location_facility: UT Southwestern/Simmons Cancer Center-Dallas

location_facility: Oklahoma Cancer Specialists and Research Institute-Tulsa

location_facility: Dixie Medical Center Regional Cancer Center

location_facility: Maine Medical Center- Scarborough Campus

location_facility: Alegent Health Bergan Mercy Medical Center

location_facility: Kaiser Permanente Medical Center - Santa Clara

location_facility: Greenville Health System Cancer Institute-Andrews

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: CHUM - Centre Hospitalier de l'Universite de Montreal

location_facility: University of Alabama at Birmingham Cancer Center

location_facility: Sutter Cancer Centers Radiation Oncology Services-Auburn

location_facility: Skagit Valley Hospital Regional Cancer Care Center

location_facility: Emory University Hospital/Winship Cancer Institute

location_facility: University of Oklahoma Health Sciences Center

location_facility: Saint Joseph's Hospital and Medical Center

location_facility: Anchorage Associates in Radiation Medicine

location_facility: Maastro Clinic-Maastricht Radiation Oncology

location_facility: Western Illinois Cancer Treatment Center

location_facility: Benefis Healthcare- Sletten Cancer Institute

location_facility: Johns Hopkins University/Sidney Kimmel Cancer Center

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Minnesota Oncology Hematology PA-Maplewood

location_facility: Prisma Health Cancer Institute - Butternut

location_facility: Odette Cancer Centre- Sunnybrook Health Sciences Centre

location_facility: Regional West Medical Center Cancer Center

location_facility: Medical Oncology and Hematology Associates-Des Moines

location_facility: Minnesota Oncology Hematology PA-Woodbury

location_facility: Norton Hospital Pavilion and Medical Campus

location_facility: Prisma Health Cancer Institute - Spartanburg

location_facility: Cancer Care Specialists of Illinois - Decatur

location_facility: Vanderbilt University/Ingram Cancer Center

location_facility: Sutter Solano Medical Center/Cancer Center

location_facility: Norton Brownsboro Hospital and Medical Campus

location_facility: OSF Saint Francis Radiation Oncology at Peoria Cancer Center

location_facility: University of Washington Medical Center - Montlake

location_facility: Geisinger Wyoming Valley/Henry Cancer Center

location_facility: Medical Oncology and Hematology Associates-Laurel

location_facility: University of Kansas Hospital-Indian Creek Campus

location_facility: UC Irvine Health/Chao Family Comprehensive Cancer Center

location_facility: University of Florida Health Science Center - Gainesville

location_facility: Kootenai Clinic Cancer Services - Post Falls

location_facility: University Health Network-Princess Margaret Hospital

location_facility: Sutter Cancer Centers Radiation Oncology Services-Vacaville

location_facility: Medical Oncology and Hematology Associates-West Des Moines

location_facility: Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

location_facility: University of California Davis Comprehensive Cancer Center

location_facility: New York-Presbyterian/Brooklyn Methodist Hospital

location_facility: Smilow Cancer Hospital Care Center-Trumbull

intervention_type: Radiation

status_simplified: Ongoing


title: A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1

summary: The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.

ReferenceCitation: Pol S, Ghalib RH, Rustgi VK, Martorell C, Everson GT, Tatum HA, Hézode C, Lim JK, Bronowicki JP, Abrams GA, Bräu N, Morris DW, Thuluvath PJ, Reindollar RW, Yin PD, Diva U, Hindes R, McPhee F, Hernandez D, Wind-Rotolo M, Hughes EA, Schnittman S. Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial. Lancet Infect Dis. 2012 Sep;12(9):671-7. doi: 10.1016/S1473-3099(12)70138-X. Epub 2012 Jun 18.

lead_sponsor: Bristol-Myers Squibb

location_country:
United States
France

location_facility: Alabama Liver & Digestive Specialists (Alds)

location_facility: University Of Colorado Denver & Hospital


acronym: ENGAGE

summary: The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.

study_type: Observational

time_perspective: Prospective

ReferenceType: result

ReferenceCitation: Böckler D, Fitridge R, Wolf Y, Hayes P, Silveira PG, Numan F, Riambau V; ENGAGE Investigators. Rationale and design of the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE): interim analysis at 30 days of the first 180 patients enrolled. J Cardiovasc Surg (Torino). 2010 Aug;51(4):481-91.

ReferenceCitation: Stokmans RA, Teijink JA, Forbes TL, Böckler D, Peeters PJ, Riambau V, Hayes PD, van Sambeek MR. Early results from the ENGAGE registry: real-world performance of the Endurant Stent Graft for endovascular AAA repair in 1262 patients. Eur J Vasc Endovasc Surg. 2012 Oct;44(4):369-75. doi: 10.1016/j.ejvs.2012.07.005. Epub 2012 Jul 24.

ReferenceCitation: Stokmans RA, Teijink JA, Cuypers PW, Riambau V, van Sambeek MR. No differences in perioperative outcome between symptomatic and asymptomatic AAAs after EVAR: an analysis from the ENGAGE Registry. Eur J Vasc Endovasc Surg. 2012 Jun;43(6):667-73. doi: 10.1016/j.ejvs.2012.02.034. Epub 2012 Mar 21.

ReferenceCitation: Dubois L, Novick TV, Harris JR, Derose G, Forbes TL. Outcomes after endovascular abdominal aortic aneurysm repair are equivalent between genders despite anatomic differences in women. J Vasc Surg. 2013 Feb;57(2):382-389.e1. doi: 10.1016/j.jvs.2012.09.075. Epub 2012 Dec 21.

ReferenceCitation: Pol RA, Zeebregts CJ, van Sterkenburg SM, Reijnen MM; ENGAGE Investigators. Thirty-day outcome and quality of life after endovascular abdominal aortic aneurysm repair in octogenarians based on the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE). J Vasc Surg. 2012 Jul;56(1):27-35. doi: 10.1016/j.jvs.2011.12.080. Epub 2012 Mar 28.

ReferenceCitation: Tang T, Sadat U, Walsh S, Hayes PD; ENGAGE Investigators. Comparison of the endurant bifurcated endograft vs. aortouni-iliac stent-grafting in patients with abdominal aortic aneurysms: experience from the ENGAGE registry. J Endovasc Ther. 2013 Apr;20(2):172-81. doi: 10.1583/1545-1550-20.2.172.

ReferenceCitation: Pol RA, Zeebregts CJ, van Sterkenburg SM, Ferreira LM, Goktay Y, Reijnen MM; Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) Investigators. Outcome and quality of life after endovascular abdominal aortic aneurysm repair in octogenarians. J Vasc Surg. 2014 Aug;60(2):308-17. doi: 10.1016/j.jvs.2014.02.009. Epub 2014 Mar 20.

ReferenceCitation: Kiguchi MM, Forbes TL, Teijink JA, Pliagas GA, Ellozy SH, Böckler D, Makaroun MS. Clinical application and early outcomes of the aortouni-iliac configuration for endovascular aneurysm repair. J Vasc Surg. 2014 Dec;60(6):1452-9. doi: 10.1016/j.jvs.2014.08.063. Epub 2014 Oct 3. Erratum in: J Vasc Surg. 2015 Jan;61(1):285. Boeckler, Dittmar [Corrected to Böckler, Dittmar].

ReferenceCitation: Faure EM, Becquemin JP, Cochennec F; ENGAGE collaborators. Predictive factors for limb occlusions after endovascular aneurysm repair. J Vasc Surg. 2015 May;61(5):1138-45.e2. doi: 10.1016/j.jvs.2014.11.084. Epub 2015 Feb 2. Review.

ReferenceCitation: Dijkstra ML, Zeebregts CJ, Verhagen HJM, Teijink JAW, Power AH, Bockler D, Peeters P, Riambau V, Becquemin JP, Reijnen MMPJ; ENGAGE investigators. Incidence, natural course, and outcome of type II endoleaks in infrarenal endovascular aneurysm repair based on the ENGAGE registry data. J Vasc Surg. 2020 Mar;71(3):780-789. doi: 10.1016/j.jvs.2019.04.486. Epub 2019 Aug 20.

ReferenceCitation: Dijkstra ML, van Sterkenburg SM, Lardenoye JW, Zeebregts CJ, Reijnen MM; ENGAGE Investigators. One-Year Outcomes of Endovascular Aneurysm Repair in High-Risk Patients Using the Endurant Stent-Graft: Comparison of the ASA Classification and SVS/AAVS Medical Comorbidity Grading System for the Prediction of Mortality and Adverse Events. J Endovasc Ther. 2016 Aug;23(4):574-82. doi: 10.1177/1526602816648455. Epub 2016 May 10.

ReferenceCitation: Broos PP, Stokmans RA, van Sterkenburg SM, Torsello G, Vermassen F, Cuypers PW, van Sambeek MR, Teijink JA. Performance of the Endurant stent graft in challenging anatomy. J Vasc Surg. 2015 Aug;62(2):312-8. doi: 10.1016/j.jvs.2015.03.024. Epub 2015 May 1.

ipd_sharing: No

ipd_sharing_description: Only multi center data will be available

lead_sponsor: Medtronic Cardiovascular

location_country:
Spain
Italy
United Kingdom
Lithuania
Belgium
South Africa
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Argentina
Uruguay
Israel
Turkey
Norway
Sweden
Slovakia
Canada
Switzerland
China
Germany
Greece
New Zealand
Thailand
Korea, Republic of
France
Colombia
Netherlands

location_facility: Complejo Hospitalario Universitario Granada Hospital Campus de la Salud

location_facility: Life Healthcare - Life Kingsbury Hospital

location_facility: CHU de Bordeaux - Centre Universitaire Pellegrin

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Hospital Universitari Clínic de Barcelona

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

location_facility: The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital

location_facility: Yonsei University health System -Severence Hospital

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Euromedica - Kyanous Stavros General Hospital

location_facility: Istanbul Universitesi - Istanbul Tip Fakultesi Hastanesi

location_facility: Hôpitaux Universitaires - Hôpital Henri Mondor

location_facility: Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

location_facility: Life Healthcare - Life St Georges Hospital

location_facility: Hospital Universitario Central de Asturias

location_facility: Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)

location_facility: St George's University Hospitals - NHS Trust

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: IKEM - Institutu Klinicke a Experimentalni Mediciny

location_facility: West China Hospital of Sichuan University

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: JMLS Medical Services PTY, trading as Perth Institute of Vascular Research

location_facility: Helse Bergen HF - Haukeland Universitetssjukehus

intervention_type: Device


title: A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)

lead_sponsor: Seagen Inc.

type: EudraCT Number

source: euctr

ReferenceCitation: Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Yang Y, Sievers EL, Kennedy DA, Shustov A. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol. 2012 Jun 20;30(18):2190-6. doi: 10.1200/JCO.2011.38.0402. Epub 2012 May 21.

ReferenceCitation: Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Fenton K, Huebner D, Pinelli JM, Kennedy DA, Shustov A. Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood. 2017 Dec 21;130(25):2709-2717. doi: 10.1182/blood-2017-05-780049. Epub 2017 Oct 3. Erratum in: Blood. 2018 Jul 26;132(4):458-459.

location_country:
United Kingdom
Canada
United States
France
Belgium

location_facility: Washington University School of Medicine

location_facility: University of Miami Sylvester Comprehensive Cancer Center

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Baylor Sammons Cancer Center / Texas Oncology

location_facility: Karmanos Cancer Institute / Wayne State University

summary: This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL.


title: A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder

lead_sponsor: Eli Lilly and Company

ReferenceCitation: Emslie GJ, Wells TG, Prakash A, Zhang Q, Pangallo BA, Bangs ME, March JS. Acute and longer-term safety results from a pooled analysis of duloxetine studies for the treatment of children and adolescents with major depressive disorder. J Child Adolesc Psychopharmacol. 2015 May;25(4):293-305. doi: 10.1089/cap.2014.0076.

ReferenceCitation: Atkinson SD, Prakash A, Zhang Q, Pangallo BA, Bangs ME, Emslie GJ, March JS. A double-blind efficacy and safety study of duloxetine flexible dosing in children and adolescents with major depressive disorder. J Child Adolesc Psychopharmacol. 2014 May;24(4):180-9. doi: 10.1089/cap.2013.0146. Epub 2014 May 9.

ReferenceCitation: Bliznak L, Berg R, Häge A, Dittmann RW. High rate of non-eligibility: methodological factors impacting on recruitment for a multicentre, double-blind study of paediatric patients with major depressive disorder. Pharmacopsychiatry. 2013 Jan;46(1):23-8. doi: 10.1055/s-0032-1314806. Epub 2012 Jun 14.

location_country:
Russian Federation
Ukraine
United States
France
South Africa
Germany
Slovakia

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: The purpose of this study is to assess whether duloxetine is superior to placebo in the treatment of children and adolescents with major depressive disorder (MDD)


title: A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

ReferenceCitation: Younes A, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Ramchandren R, Bartlett NL, Cheson BD, de Vos S, Forero-Torres A, Moskowitz CH, Connors JM, Engert A, Larsen EK, Kennedy DA, Sievers EL, Chen R. Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma. J Clin Oncol. 2012 Jun 20;30(18):2183-9. doi: 10.1200/JCO.2011.38.0410. Epub 2012 Mar 26.

ReferenceCitation: Chen R, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Connors JM, Engert A, Larsen EK, Huebner D, Fong A, Younes A. Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2016 Sep 22;128(12):1562-6. doi: 10.1182/blood-2016-02-699850. Epub 2016 Jul 18.

ReferenceCitation: Gopal AK, Chen R, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Connors JM, Engert A, Larsen EK, Chi X, Sievers EL, Younes A. Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma. Blood. 2015 Feb 19;125(8):1236-43. doi: 10.1182/blood-2014-08-595801. Epub 2014 Dec 22.

location_country:
Italy
Canada
United States
France
Belgium

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Loyola University Medical Center Cardinal Bernardin Cancer Center

location_facility: Instituto di Ematologia ed Oncologia Medica

location_facility: Cliniques Universitaires UCL de Mont-Goddine

summary: This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma.


status: Terminated

title: A Phase 2B Extension Study of PTC124 in Subjects With Nonsense-Mutation-Mediated Duchenne and Becker Muscular Dystrophy

lead_sponsor: PTC Therapeutics

ReferenceType: background

ReferenceCitation: Hirawat S, Welch EM, Elfring GL, Northcutt VJ, Paushkin S, Hwang S, Leonard EM, Almstead NG, Ju W, Peltz SW, Miller LL. Safety, tolerability, and pharmacokinetics of PTC124, a nonaminoglycoside nonsense mutation suppressor, following single- and multiple-dose administration to healthy male and female adult volunteers. J Clin Pharmacol. 2007 Apr;47(4):430-44.

ReferenceCitation: Welch EM, Barton ER, Zhuo J, Tomizawa Y, Friesen WJ, Trifillis P, Paushkin S, Patel M, Trotta CR, Hwang S, Wilde RG, Karp G, Takasugi J, Chen G, Jones S, Ren H, Moon YC, Corson D, Turpoff AA, Campbell JA, Conn MM, Khan A, Almstead NG, Hedrick J, Mollin A, Risher N, Weetall M, Yeh S, Branstrom AA, Colacino JM, Babiak J, Ju WD, Hirawat S, Northcutt VJ, Miller LL, Spatrick P, He F, Kawana M, Feng H, Jacobson A, Peltz SW, Sweeney HL. PTC124 targets genetic disorders caused by nonsense mutations. Nature. 2007 May 3;447(7140):87-91. Epub 2007 Apr 22.

location_country:
Spain
Italy
United Kingdom
Australia
Canada
Sweden
United States
France
Israel
Belgium
Germany

location_facility: University of Iowa Children's Hospital, Division of Child Neurology

location_facility: Groupe Hospitalier Pitie-Salpetriere, Institut de Myologie

location_facility: University of Essen - Clinic for Children

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: UCL Instititute of Child Health, Dubowitz

location_facility: Department of Rehabilitation, The Children's Hospital

location_facility: Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: U.O. Complessa di Neuropsichiatria Infantile-Policlinico A. Gemelli-Universita Cattolica

location_facility: Robert Jones & Agnes Hunt Orthopaedic Hospital

summary: Duchenne/Becker muscular dystrophy (DMD/BMD) is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability during childhood and teenage years. A specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of DMD/BMD in approximately 10-15% of boys with the disease. Ataluren (PTC124) is an orally delivered, investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 2b extension trial that will evaluate the long-term safety of ataluren (PTC124) in boys with nonsense mutation DMD/BMD, as determined by adverse events and laboratory abnormalities. The study will also assess changes in walking, muscle function, and other important clinical and laboratory measures.

status_simplified: Unknown


title: A Randomized Phase III Study of Weekly ABI-007 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Adenocarcinoma of the Pancreas

summary: Phase III Metastatic Pancreatic Cancer

ReferenceCitation: Tabernero J, Chiorean EG, Infante JR, Hingorani SR, Ganju V, Weekes C, Scheithauer W, Ramanathan RK, Goldstein D, Penenberg DN, Romano A, Ferrara S, Von Hoff DD. Prognostic factors of survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer. Oncologist. 2015 Feb;20(2):143-50. doi: 10.1634/theoncologist.2014-0394. Epub 2015 Jan 12.

ReferenceCitation: Chiorean EG, Von Hoff DD, Tabernero J, El-Maraghi R, Ma WW, Reni M, Harris M, Whorf R, Liu H, Li JS, Manax V, Romano A, Lu B, Goldstein D. Second-line therapy after nab-paclitaxel plus gemcitabine or after gemcitabine for patients with metastatic pancreatic cancer. Br J Cancer. 2016 Jul 12;115(2):188-94. doi: 10.1038/bjc.2016.185. Epub 2016 Jun 28. Erratum in: Br J Cancer. 2016 Oct 25;115(9):e13.

ReferenceCitation: Tehfe M, Dowden S, Kennecke H, El-Maraghi R, Lesperance B, Couture F, Letourneau R, Liu H, Romano A. nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma: Canadian Subgroup Analysis of the Phase 3 MPACT Trial. Adv Ther. 2016 May;33(5):747-59. doi: 10.1007/s12325-016-0327-4. Epub 2016 Apr 16. Erratum in: Adv Ther. 2016 Nov 24;:.

ReferenceCitation: Scheithauer W, Ramanathan RK, Moore M, Macarulla T, Goldstein D, Hammel P, Kunzmann V, Liu H, McGovern D, Romano A, Von Hoff DD. Dose modification and efficacy of nab-paclitaxel plus gemcitabine vs. gemcitabine for patients with metastatic pancreatic cancer: phase III MPACT trial. J Gastrointest Oncol. 2016 Jun;7(3):469-78. doi: 10.21037/jgo.2016.01.03.

ReferenceCitation: Vogel A, Römmler-Zehrer J, Li JS, McGovern D, Romano A, Stahl M. Efficacy and safety profile of nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic cancer treated to disease progression: a subanalysis from a phase 3 trial (MPACT). BMC Cancer. 2016 Oct 21;16(1):817.

ReferenceCitation: Kunzmann V, Ramanathan RK, Goldstein D, Liu H, Ferrara S, Lu B, Renschler MF, Von Hoff DD. Tumor Reduction in Primary and Metastatic Pancreatic Cancer Lesions With nab-Paclitaxel and Gemcitabine: An Exploratory Analysis From a Phase 3 Study. Pancreas. 2017 Feb;46(2):203-208. doi: 10.1097/MPA.0000000000000742.

ReferenceCitation: Tabernero J, Kunzmann V, Scheithauer W, Reni M, Shiansong Li J, Ferrara S, Djazouli K. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: a subgroup analysis of the Western European cohort of the MPACT trial. Onco Targets Ther. 2017 Feb 2;10:591-596. doi: 10.2147/OTT.S124097. eCollection 2017.

ReferenceCitation: Ramanathan RK, Goldstein D, Korn RL, Arena F, Moore M, Siena S, Teixeira L, Tabernero J, Van Laethem JL, Liu H, McGovern D, Lu B, Von Hoff DD. Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas. Ann Oncol. 2016 Apr;27(4):648-53. doi: 10.1093/annonc/mdw020. Epub 2016 Jan 22.

ReferenceCitation: Chiorean EG, Von Hoff DD, Reni M, Arena FP, Infante JR, Bathini VG, Wood TE, Mainwaring PN, Muldoon RT, Clingan PR, Kunzmann V, Ramanathan RK, Tabernero J, Goldstein D, McGovern D, Lu B, Ko A. CA19-9 decrease at 8 weeks as a predictor of overall survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer. Ann Oncol. 2016 Apr;27(4):654-60. doi: 10.1093/annonc/mdw006. Epub 2016 Jan 22.

ReferenceCitation: Goldstein D, Von Hoff DD, Moore M, Greeno E, Tortora G, Ramanathan RK, Macarulla T, Liu H, Pilot R, Ferrara S, Lu B. Development of peripheral neuropathy and its association with survival during treatment with nab-paclitaxel plus gemcitabine for patients with metastatic adenocarcinoma of the pancreas: A subset analysis from a randomised phase III trial (MPACT). Eur J Cancer. 2016 Jan;52:85-91. doi: 10.1016/j.ejca.2015.10.017. Epub 2015 Dec 1.

ReferenceCitation: Portal A, Pernot S, Tougeron D, Arbaud C, Bidault AT, de la Fouchardière C, Hammel P, Lecomte T, Dréanic J, Coriat R, Bachet JB, Dubreuil O, Marthey L, Dahan L, Tchoundjeu B, Locher C, Lepère C, Bonnetain F, Taieb J. Nab-paclitaxel plus gemcitabine for metastatic pancreatic adenocarcinoma after Folfirinox failure: an AGEO prospective multicentre cohort. Br J Cancer. 2015 Sep 29;113(7):989-95. doi: 10.1038/bjc.2015.328. Epub 2015 Sep 15.

ReferenceCitation: Goldstein D, El-Maraghi RH, Hammel P, Heinemann V, Kunzmann V, Sastre J, Scheithauer W, Siena S, Tabernero J, Teixeira L, Tortora G, Van Laethem JL, Young R, Penenberg DN, Lu B, Romano A, Von Hoff DD. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: long-term survival from a phase III trial. J Natl Cancer Inst. 2015 Jan 31;107(2). pii: dju413. doi: 10.1093/jnci/dju413. Print 2015 Feb.

ReferenceCitation: Vogel A, Pelzer U, Salah-Eddin AB, Köster W. First-line nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer from routine clinical practice. In Vivo. 2014 Nov-Dec;28(6):1135-40.

ReferenceCitation: Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.

ReferenceCitation: Von Hoff DD, Cridebring D, Tian OY, Han H, Bhore R, Franco T, Ondovik MS, Louis CU. Analysis of the Role of Plasma 25-Hydroxyvitamin D Levels in Survival Outcomes in Patients from the Phase III MPACT Trial of Metastatic Pancreatic Cancer. Oncologist. 2021 Apr;26(4):e704-e709. doi: 10.1002/onco.13645. Epub 2021 Jan 11.

ReferenceCitation: McCleary-Wheeler AL, McWilliams R, Fernandez-Zapico ME. Aberrant signaling pathways in pancreatic cancer: a two compartment view. Mol Carcinog. 2012 Jan;51(1):25-39. doi: 10.1002/mc.20827.

lead_sponsor: Celgene

location_country:
Spain
Italy
Austria
Australia
Russian Federation
Canada
Ukraine
United States
France
Belgium
Germany

location_facility: Ospedale Casa Sollievo della Sofferenza IRCCS

location_facility: The Center for Cancer and Blood Disorders

location_facility: Northern Arizona Hematology and Oncology Associates-AOA

location_facility: E. O. Ospedali Galliera, Struttura Complessa Oncologia Medica

location_facility: Texas Oncology, PA/ Methodist Charlton Cancer Center

location_facility: University of Minnesota, Masonic Cancer Center

location_facility: Desert Hematology Oncology Medical Group, Inc.

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: Istituto Nazionale Tumori "Regina Elena"

location_facility: Moscow City Clinical Hosp #57 Chemotherapy Dept

location_facility: Russian Research Ctr for Radiology and Surgical Technologies

location_facility: Med Radiological Centre of the Russian Academy of Med Sciences

location_facility: The Center for Cancer and Hematologic Disease

location_facility: Cancer Care & Hematology Specialists of Chicagoland

location_facility: Centre Hospitalier de L'Universite de Montreal St-Luc

location_facility: Lviv Regional Diagnostics and Treatment and Diagnostics Onc Ctr

location_facility: University of Oklahoma Health Science Center

location_facility: Chattanooga Oncology Hematology Associates

location_facility: The University of Texas Medical School at Houston

location_facility: Cancer Care & Hemaotology Specialists of Chicagoland

location_facility: Haematology Oncology Clinics of Australasia-Gold Coast

location_facility: Clearview Cancer Institute Oncology Specialities, P.C.

location_facility: O.F. Herbachevskyi Regional Clinical Hospital, Surgery Center

location_facility: Haemotology & Oncology Australasia (HOCA)

location_facility: Praxis für Innere Medizin, Dr. Oettle Helmut

location_facility: Signal Point Clinical Research Center, LLC

location_facility: Adelaide Cancer Centre (T/A Ashford Cancer Ctr)

location_facility: Azienda Ospedaliero universitaria Pisana

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Central Clinical Hosp of the President of the Russian Federation

location_facility: National Institute of Cancer, Department of Tumors of Abdominal Cavity and Retroperitoneum

location_facility: Volyn Regional Oncology Center Department of Oncochemotherapy

location_facility: Russian Res Ctr of Radiology under the Fed Agency for Hi-Tech Med Care

location_facility: Fairfax-Northern Virginia Hematology-Oncology, P.C.

location_facility: South Texas Oncology and Hematology, P.A

location_facility: Zaporizhia Medical Academy of Postgraduate Education

location_facility: Arcispedale Santa Maria Nuova, Unità Operativa di Oncologia Medica

location_facility: TGEN Clinical Research Services at Scottsdale Healthcare

location_facility: UAB Comprenhensive Cancer Center at University of Alabama

location_facility: Kirovohrad Regional Oncology Center, Department of Chemotherapy

location_facility: I.R.C.C.S. "Giovanni Paolo II" - Istituto Oncologico

location_facility: Russian Research Ctr of Surgery n.a. B.V. Petrovskiy under the Russian Academy of Med Sciences

location_facility: Centre Regional de lutte contre le cancer Paul Papin

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Kyiv City Clinical Hospital #10, Center for Hepatic, Bile Duct and Pancreatic Surgery

location_facility: Arizona Cancer Center, University of Arizona

location_facility: St. Petersburg State Med Academy n.a.Mechnikov

location_facility: Sidney Kimmel Comphrensive Cancer Center, John Hopkins University

location_facility: Pyatigorsk Affiliate of Stavropol Regional Onc Ctr

location_facility: St. Mary Medical Center Hem-Onc Group, PC

location_facility: Cancer Center of Excellence/University of MA Medical School


title: Oral Direct Factor Xa Inhibitor BAY 59-7939 in the Prevention of VTE in Patients Undergoing Total Hip Replacement. ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial

acronym: ODiXaHip

summary: Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE (up to 60 % without prophylaxis). The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk, but heparins have to be applied below the skin (subcutaneously). Additionally, there is a chance of developing a heparin-induced thrombocytopenia (decrease in platelets). Therefore, there is still a need for new agents which are safer and more efficient and which are easier to apply.The purpose of this study is to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the licensed drug Enoxaparin. Enoxaparin, a so-called low molecular heparin, is approved and widely used in the area of thromboprophylaxis and will be given once daily subcutaneously.Another important purpose of the study is to find the optimal dose of BAY 59-7939 for thromboprophylaxis after hip replacement surgery. Therefore, there are several dose steps planned.

primary_purpose: Prevention

lead_sponsor: Bayer

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


title: An Open-Label, Multi-Centre, Randomised, Phase Ib Study to Investigate the Safety and Efficacy of RO5072759 Given in Combination With CHOP, FC or Bendamustine Chemotherapy in Patients With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma

acronym: GAUDI

summary: This open-label, randomized, phase Ib study will assess the safety and efficacy of obinutuzumab given in combination with FC (fludarabine and cyclophosphamide) or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) or bendamustine induction chemotherapy in participants with Cluster of Differentiation (CD) 20+ B-cell Follicular Lymphoma (FL). Participants with complete response or partial response after induction therapy may receive maintenance therapy every 3 months for 2 years or until disease progression, whichever comes first. All participants in the induction period of the study will have a safety follow-up visit 28 days after completing the last dose of obinutuzumab + chemotherapy, and will be followed for at least 2 years, unless they are being treated in maintenance or discontinue from the study prior to this time point. Participants who complete/discontinue maintenance therapy will also be followed for a period of 2 years after receiving the last dose of obinutuzumab or until progression/new antilymphoma treatment.

ReferenceCitation: Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12.

ReferenceCitation: Grigg A, Dyer MJ, Díaz MG, Dreyling M, Rule S, Lei G, Knapp A, Wassner-Fritsch E, Marlton P. Safety and efficacy of obinutuzumab with CHOP or bendamustine in previously untreated follicular lymphoma. Haematologica. 2017 Apr;102(4):765-772. doi: 10.3324/haematol.2016.152272. Epub 2016 Dec 23.

ReferenceCitation: Cartron G, Hourcade-Potelleret F, Morschhauser F, Salles G, Wenger M, Truppel-Hartmann A, Carlile DJ. Rationale for optimal obinutuzumab/GA101 dosing regimen in B-cell non-Hodgkin lymphoma. Haematologica. 2016 Feb;101(2):226-34. doi: 10.3324/haematol.2015.133421. Epub 2015 Dec 11.

ReferenceCitation: Radford J, Davies A, Cartron G, Morschhauser F, Salles G, Marcus R, Wenger M, Lei G, Wassner-Fritsch E, Vitolo U. Obinutuzumab (GA101) plus CHOP or FC in relapsed/refractory follicular lymphoma: results of the GAUDI study (BO21000). Blood. 2013 Aug 15;122(7):1137-43. doi: 10.1182/blood-2013-01-481341. Epub 2013 Jul 10.

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
United Kingdom
Australia
France
Germany


title: An Extension to a 12-month, Open-label, Randomised, Multicenter, Sequential Cohort, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Cyclosporine in Combination With Everolimus, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients

lead_sponsor: Novartis Pharmaceuticals

location_country:
Taiwan
Brazil
Spain
Colombia
Austria
Australia
Italy
Argentina
Czech Republic
Netherlands
Switzerland
France
Singapore
Belgium
Norway
Germany
Slovakia

summary: This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.


title: A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension

summary: This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for the treatment of PAH or the study is closed.

design_allocation: Non-Randomized

lead_sponsor: Pfizer

location_country:
Poland
Brazil
Spain
Italy
Austria
Australia
Mexico
Argentina
Canada
Netherlands
United Kingdom
United States
France
Israel
Belgium
Germany


title: A Safety and Efficacy Study of Blood Pressure Control in Acute Heart Failure - A Pilot Study (PRONTO)

acronym: PRONTO

summary: The purpose of this study was to evaluate the efficacy and safety of intravenous (IV) clevidipine as compared with standard of care IV antihypertensive agents for blood pressure (BP) lowering in patients with acute heart failure and elevated BP.

lead_sponsor: The Medicines Company

location_country:
Germany
United States
France

location_facility: Washington University School of Medicine

location_facility: Louisiana State University Health Sciences Center - Emergency Medicine

location_facility: Stony Brook University and Medical Center

location_facility: Hopital AP-HP Lariboisiere Urgencies-SMUR


title: A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis

type: Other Grant/Funding Number

ReferenceCitation: Kerem E, Konstan MW, De Boeck K, Accurso FJ, Sermet-Gaudelus I, Wilschanski M, Elborn JS, Melotti P, Bronsveld I, Fajac I, Malfroot A, Rosenbluth DB, Walker PA, McColley SA, Knoop C, Quattrucci S, Rietschel E, Zeitlin PL, Barth J, Elfring GL, Welch EM, Branstrom A, Spiegel RJ, Peltz SW, Ajayi T, Rowe SM; Cystic Fibrosis Ataluren Study Group. Ataluren for the treatment of nonsense-mutation cystic fibrosis: a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Respir Med. 2014 Jul;2(7):539-47. doi: 10.1016/S2213-2600(14)70100-6. Epub 2014 May 15.

location_country:
Spain
Italy
United Kingdom
Netherlands
Canada
Sweden
United States
France
Israel
Belgium
Germany

location_facility: Karolinska University Hospital, Huddinge

location_facility: Hôpital Universitaire des Enfants Reine Fabiola

location_facility: Hadassah University Hospital - Mount Scopus

summary: Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A specific type of mutation called a nonsense (premature stop codon) mutation is the cause of CF in approximately 10% of patients with the disease. Ataluren is an orally delivered investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 3 trial that will evaluate the clinical benefit of ataluren in adult and pediatric participants with CF due to a nonsense mutation. The main goals of the study are to understand whether ataluren can improve pulmonary function and whether the drug can safely be given for a long period of time. The study will also assess the effects of ataluren on CF pulmonary exacerbation frequency, cough frequency, health-related quality of life, antibiotic use for CF-related infections, CF-related disruptions to daily living, body weight, and CF pathophysiology.


title: Controlled, Randomized, Prospective, Double-Blind, Multicenter, Phase I/II, Dose-Escalation Study of the Safety, PK, and Clinical Activity of I5NP for Prophylaxis of Delayed Graft Function in Patients Undergoing Deceased Donor Kidney Transplantation

summary:
The purpose of this study is to determine whether a single administration of QPI-1002 (also known as I5NP) can prevent DGF in patients undergoing deceased donor kidney transplantation. In this Phase I /II study, patients who are undergoing renal transplantation with organs from DCD donors, ECD donors or SCD donors with ≥ 24 hours of cold ischemia time who meet study entry criteria will be studied to evaluate the safety and pharmacokinetic profile of I5NP (Part A) and clinical activity of I5NP administration (Part B). Data from this study will be used to identify doses of I5NP to be used in follow-on efficacy studies.

Part A will be a randomized, dose escalation study to determine the highest or maximum tolerated dose (MTD). Part A will enroll 40 patients at approximately 20 sites; patients will be randomized to receive either I5NP or placebo in a ratio of 8:2 in each cohort (cohorts 1-4).

Part B will utilize the dose identified in Part A to further evaluate, in a double-blind manner, the safety, and clinical activity of I5NP. In Part B, up to 326 patients will participate at approximately 60 sites; up to 163 patients will be randomized to receive I5NP and up to 163 patients randomized to receive placebo.

lead_sponsor: Quark Pharmaceuticals

location_country:
Spain
Canada
United States
France
Germany

location_facility: QE II Capital District Health Authority, Halifax

location_facility: University of Colorado Health Science Center

location_facility: Transplant Research Institute (TRI; formerly NIT)


acronym: STEPS

title: A 24-Week Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome

lead_sponsor: Shire

ReferenceCitation: Jeppesen PB, Sanguinetti EL, Buchman A, Howard L, Scolapio JS, Ziegler TR, Gregory J, Tappenden KA, Holst J, Mortensen PB. Teduglutide (ALX-0600), a dipeptidyl peptidase IV resistant glucagon-like peptide 2 analogue, improves intestinal function in short bowel syndrome patients. Gut. 2005 Sep;54(9):1224-31.

ReferenceCitation: Jeppesen PB, Gabe SM, Seidner DL, Lee HM, Olivier C. Citrulline correlations in short bowel syndrome-intestinal failure by patient stratification: Analysis of 24 weeks of teduglutide treatment from a randomized controlled study. Clin Nutr. 2020 Aug;39(8):2479-2486. doi: 10.1016/j.clnu.2019.11.001. Epub 2019 Nov 9.

ReferenceCitation: Jeppesen PB, Gabe SM, Seidner DL, Lee HM, Olivier C. Factors Associated With Response to Teduglutide in Patients With Short-Bowel Syndrome and Intestinal Failure. Gastroenterology. 2018 Mar;154(4):874-885. doi: 10.1053/j.gastro.2017.11.023. Epub 2017 Nov 22.

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.

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.

ReferenceCitation: Jeppesen PB, Pertkiewicz M, Forbes A, Pironi L, Gabe SM, Joly F, Messing B, Loth S, Youssef NN, Heinze H, Berghöfer P. Quality of life in patients with short bowel syndrome treated with the new glucagon-like peptide-2 analogue teduglutide--analyses from a randomised, placebo-controlled study. Clin Nutr. 2013 Oct;32(5):713-21. doi: 10.1016/j.clnu.2013.03.016. Epub 2013 Mar 28.

ReferenceCitation: Berghöfer P, Fragkos KC, Baxter JP, Forbes A, Joly F, Heinze H, Loth S, Pertkiewicz M, Messing B, Jeppesen PB. Development and validation of the disease-specific Short Bowel Syndrome-Quality of Life (SBS-QoL™) scale. Clin Nutr. 2013 Oct;32(5):789-96. doi: 10.1016/j.clnu.2012.12.001. Epub 2012 Dec 12.

ReferenceCitation: Jeppesen PB, Pertkiewicz M, Messing B, Iyer K, Seidner DL, O'keefe SJ, Forbes A, Heinze H, Joelsson B. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure. Gastroenterology. 2012 Dec;143(6):1473-1481.e3. doi: 10.1053/j.gastro.2012.09.007. Epub 2012 Sep 11.

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Netherlands
Canada
United States
France
Germany

location_facility: Rigshospitalet - Abdominalcentret, Hepatologisk Kilinik A

location_facility: Samodzielny Publiczny Szpital Kliniczny im. prof W. Orlowskiego CMKP, Oddzial Kliniczny Zywienia i Chirurgii

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Pirogowa, Pracownia Leczenia Zywieniowego

location_facility: Hôpital Croix Rousse Unité de Nutrition Clinique Intensive

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej

location_facility: University Health Network - Toronto General Hospital

location_facility: Azienda Ospedaliera Universitaria S. Giovanni Battista - Le Molinette

location_facility: Med. Klinik m.S. Hepatologie und Gastroenterologie

location_facility: Azienda Universitaria Policlinico Federico II

location_facility: Green Area, Main Hospital Salford Royal Hospitals NHS Foundation Trust

location_facility: Universitair Medisch Centrum St. Radboud

location_facility: Polyclinic Family and Specialty Medicine Facility

location_facility: Policlinico Sant'Orsola - Malpighi centro insufficienza intestinale

location_facility: Critical Care Research, Royal Alexandra Hospital

summary: Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. This study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in SBS subjects.


title: An Open-label Study to Determine the Effect of R1507 Plus Tarceva (Erlotinib) on Progression-free Survival in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) With Progressive Disease After Clinical Benefit to Second or Third Line Tarceva Monotherapy.

summary: This single arm study in patients with advanced Stage IIIb/IV NSCLC who have progressive disease after deriving clinical benefit (defined as response or stable disease after 12 weeks) from second or third line Tarceva monotherapy will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva. Patients will receive R1507 (9mg/kg iv) weekly in combination with Tarceva (150mg oral daily) for up to a maximum of 24 months. Other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.

location_country:
Poland
United States
Canada
France


title: A Randomised, Double-blind, Parallel-group, Active-controlled, Flexible Dose Study Exploring the Efficacy and Safety of 12 Weeks Treatment With Lu 31-130 in Patients With Schizophrenia

lead_sponsor: H. Lundbeck A/S

location_country:
Poland
Hong Kong
Spain
Czech Republic
Indonesia
Thailand
France
Philippines

summary: The main purpose with the study is to explore the efficacy and safety of Lu 31-130 in patients suffering from schizophrenia compared to a standard antipsychotic drug.


title: A Multicenter, Randomized, Open-Label, Active-Controlled Pilot Study to Evaluate the Safety and Antiretroviral Activity of Unboosted Atazanavir BID Plus Raltegravir BID and Boosted Atazanavir QD in Combination With Tenofovir/Emtricitabine QD in Treatment Naive HIV-Infected Subjects

acronym: SPARTAN

summary: The purpose of this study is to determine if the combination of atazanavir and raltegravir taken together is safe and effective in the treatment of human immunodeficiency virus (HIV).

ReferenceCitation: Kozal MJ, Lupo S, DeJesus E, Molina JM, McDonald C, Raffi F, Benetucci J, Mancini M, Yang R, Wirtz V, Percival L, Zhang J, Zhu L, Arikan D, Farajallah A, Nguyen BY, Leavitt R, McGrath D, Lataillade M, The Spartan Study Team. A nucleoside- and ritonavir-sparing regimen containing atazanavir plus raltegravir in antiretroviral treatment-naïve HIV-infected patients: SPARTAN study results. HIV Clin Trials. 2012 May-Jun;13(3):119-30. doi: 10.1310/hct1303-119.

location_country:
United States
Argentina
France

location_facility: Tarrant County Infectious Disease Associates


title: A Randomized, Double-Blind, Multi-Center Phase II Trial of Exemestane (AromasinÂ®) Plus Dasatinib Versus Exemestane Plus Placebo in Advanced Estrogen Receptor-Positive Breast Cancer After Disease Progression on a Non-Steroidal Aromatase Inhibitor (NSAI)

summary: The purpose of this study is to determine whether exemestane plus dasatinib will be well-tolerated and will increase progression-free survival (PFS) in the treatment of advanced estrogen-receptor positive (ER+) breast cancer after disease progression (PD) on a non-steroidal aromatase inhibitor (NSAI).

location_country:
Poland
Spain
Ireland
United Kingdom
Czech Republic
United States
France
Sweden

location_facility: Compassionate Cancer Care Medical Group Inc

location_facility: Compassionate Cancer Care Medical Group, Inc


title: A Prospective, Multicenter, Double-blind, Randomized, Comparative Study to Estimate the Safety, Tolerability and Efficacy of NXL104/Ceftazidime Plus Metronidazole vs. Meropenem in the Treatment of Complicated Intra-abdominal Infections in Hospitalized Adults

summary: The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated intra-abdominal infections as compared to a comparator group.

ReferenceCitation: Nichols WW, Stone GG, Newell P, Broadhurst H, Wardman A, MacPherson M, Yates K, Riccobene T, Critchley IA, Das S. Ceftazidime-Avibactam Susceptibility Breakpoints against Enterobacteriaceae and Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2018 Oct 24;62(11). pii: e02590-17. doi: 10.1128/AAC.02590-17. Print 2018 Nov.

location_country:
Poland
Russian Federation
Lebanon
India
United States
France
Romania
Bulgaria

location_facility: Multiprofile Hospital for Active Trt Emergency Med

location_facility: Amrita Institute of Medical Sciences, Cochin

location_facility: UMHAT Queen Joanna-ISUL, Clinical of Surgery

location_facility: Hammound Hospital University Medical Center

location_facility: Cedars-Sinai Medical Center Dept of Surgery

location_facility: CCB Ministry of Interior Clinical of Surgery

location_facility: UMHAT Sveti Georgi 3rd Clinical of Surgery


title: A Randomized, Double-blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder

lead_sponsor: Takeda

ReferenceCitation: Henigsberg N, Mahableshwarkar AR, Jacobsen P, Chen Y, Thase ME. A randomized, double-blind, placebo-controlled 8-week trial of the efficacy and tolerability of multiple doses of Lu AA21004 in adults with major depressive disorder. J Clin Psychiatry. 2012 Jul;73(7):953-9. doi: 10.4088/JCP.11m07470.

ReferenceCitation: McIntyre RS, Florea I, Tonnoir B, Loft H, Lam RW, Christensen MC. Efficacy of Vortioxetine on Cognitive Functioning in Working Patients With Major Depressive Disorder. J Clin Psychiatry. 2017 Jan;78(1):115-121. doi: 10.4088/JCP.16m10744.

location_country:
Poland
Taiwan
United Kingdom
Latvia
Russian Federation
Australia
Netherlands
Lithuania
Czech Republic
Ukraine
Korea, Republic of
France
Malaysia
South Africa
Germany

summary: The purpose of this study is to determine the effectiveness and safety of vortioxetine, once daily (QD), in patients with Major Depressive Disorder.


acronym: ASPIRE

title: A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients With Schizophrenia

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Croatia
Serbia
Spain
United States
Romania
Philippines
Belgium
South Africa
Poland
Austria
Australia
Russian Federation
Argentina
Puerto Rico
India
Mexico
Norway
Malaysia
Slovakia
Hungary
Bulgaria
Taiwan
Estonia
Finland
Thailand
Korea, Republic of
France
Chile

summary: To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance treatment in patients with schizophrenia.


title: A Multicenter, Double-blind, Randomized Study to Compare the Efficacy of 24 Weeks Treatment With Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) Versus Metformin Monotherapy (1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy.

summary: The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.

location_country:
Poland
Hungary
United States
France
Germany

location_facility: Samodzielny Publiczny Szpital Kliniczny NR 1 im. Prof. Stanislawa Szysko SAM

location_facility: SZPZOZ Szpital Zachodni im. Jana Pawla II

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: NZCZ Regionalna Poradnia Diabetologiczna

location_facility: Zespół Opieki Zdrowotnej w Łęczycy, Poradnia Diabetologiczna Łeczyca

location_facility: Szspital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Ponza

location_facility: NZOZ Specjalistyczny Ośrodek Internistyczno - Diabetologiczny Białystok

location_facility: Poradnia Diabetologiczna, Zespol Opieki Zdrowotnej w Leczycy


title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of Oral Cladribine in Subjects With a First Clinical Event at High Risk of Converting to MS

acronym: ORACLE MS

summary: A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of oral cladribine versus placebo in participants who had a first clinical demyelinating event (clinically isolated syndrome). Participants in either the cladribine or placebo group may also enter treatment periods with open-label interferon-beta or open-label cladribine depending upon the disease status. The primary objective of this study is to evaluate the effect of two dosage regimens of oral cladribine versus placebo on the time to conversion to multiple sclerosis (MS) (from randomization) according to the Poser criteria in participants with first clinical demyelinating event at high risk of converting to MS.

ReferenceCitation: Oh J, Walker B, Giovannoni G, Jack D, Dangond F, Nolting A, Aldridge J, Lebson LA, Leist TP. Side effects that occurred early in people with multiple sclerosis during the first year of treatment with cladribine tablets: a plain language summary. Neurodegener Dis Manag. 2022 Feb 1;12(1):1-7. doi: 10.2217/nmt-2021-0041. Epub 2022 Jan 12. Review.

ReferenceCitation: Giovannoni G, Coyle PK, Vermersch P, Walker B, Aldridge J, Nolting A, Galazka A, Lemieux C, Leist TP. Integrated Lymphopenia Analysis in Younger and Older Patients With Multiple Sclerosis Treated With Cladribine Tablets. Front Immunol. 2021 Dec 24;12:763433. doi: 10.3389/fimmu.2021.763433. eCollection 2021.

ReferenceCitation: Giovannoni G, Galazka A, Schick R, Leist T, Comi G, Montalban X, Damian D, Dangond F, Cook S. Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis: An Integrated Analysis of Safety. Drug Saf. 2020 Jul;43(7):635-643. doi: 10.1007/s40264-020-00948-x.

ReferenceCitation: Freedman MS, Leist TP, Comi G, Cree BA, Coyle PK, Hartung HP, Vermersch P, Damian D, Dangond F. The efficacy of cladribine tablets in CIS patients retrospectively assigned the diagnosis of MS using modern criteria: Results from the ORACLE-MS study. Mult Scler J Exp Transl Clin. 2017 Oct 9;3(4):2055217317732802. doi: 10.1177/2055217317732802. eCollection 2017 Oct-Dec.

ReferenceCitation: Leist TP, Comi G, Cree BA, Coyle PK, Freedman MS, Hartung HP, Vermersch P, Casset-Semanaz F, Scaramozza M; oral cladribine for early MS (ORACLE MS) Study Group. Effect of oral cladribine on time to conversion to clinically definite multiple sclerosis in patients with a first demyelinating event (ORACLE MS): a phase 3 randomised trial. Lancet Neurol. 2014 Mar;13(3):257-67. doi: 10.1016/S1474-4422(14)70005-5. Epub 2014 Feb 4.

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Romania
Czechia
Poland
Portugal
Austria
Russian Federation
Argentina
India
Turkey
Norway
Singapore
Sweden
Bosnia and Herzegovina
Lebanon
Canada
North Macedonia
Germany
Bulgaria
Taiwan
Georgia
Estonia
Finland
Thailand
Korea, Republic of
France
United Arab Emirates

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika

location_facility: Azienda Sanitaria Ospedaliera San Luigi Gonzaga

location_facility: University of Medicine and Dentistry of New Jersey School of Neurology

location_facility: Department of Neurology, 50 Ilwon-dong, Gangnam-gu

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: Wojewodzki Szpital Specjalistyczny Oddział Neurologii z Pododdziałem Udarowym

location_facility: Non-State Healthcare Institution "Central Clinical Hospital #2 named after N.A. Semasko of Russian Railways"

location_facility: Municipal Healthcare Institution "City Clinical Hospital #3"

location_facility: Vladimir Regional State Healthcare Institution "Regional Clinical Hospital"

location_facility: Neurology & Neurological Association of Tacoma

location_facility: State Educational Institution of Higher Professional Education "Samara State Medical University of Roszdrav" on State Healthcare Institution "Samara Regional Clinical Hospital named after M. I. Kalinin"

location_facility: Multiple Sclerosis Center of Northeastern NY

location_facility: Municipal Treatment Prophylactic Institution "City Hospital #33"

location_facility: State Healthcare Institution "Rostov Region Clinical Hospital"

location_facility: Municipal Healthcare Institution "Yaroslavi Clinical Hospital #8"

location_facility: Ospedale Binaghi Centro Sclerosi Multipla

location_facility: Closed joint-stock society Medical sanitary unit "Nephtaynik" based the hospital

location_facility: S. Khechinashvili Tbilisi State Medical University

location_facility: Hope Research Institute Medical Plaza LLC Desert Hills

location_facility: CHU de Liege - Domaine Universitaire du Sart Tilman,

location_facility: University of Colorado at Denver Health Sciences

location_facility: Vinnylsia Regional Psychoneurological Hosptial Named After O. I Yushchenko, Neurological Depart, Vinnytsia National Medical University Named After M. I. Pirogov, Chair of Neurology

location_facility: Regional State Healthcare Institution "State Smolensk Region Clinical Hospital"

location_facility: Seoul National University Hospital, Department of Neurology

location_facility: International Clinic and Hospital, Neurology

location_facility: State Established "Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine", Depart of Neurinfections and Multiple Sclorosis

location_facility: Department of Neurology, Asan Medical Center, 388-1 Pungnap 2-dong, Songpa-gu

location_facility: Chang Gung Medical Foundation- Linkou Branch No5

location_facility: Neurologian Klinikka Seinajoen Keskussairaala

location_facility: Federal State Institution " Siberian Reginal Medical Center of Roszdarv"

location_facility: State Educational Institution of Higher Professional Education "Saratov State Medical University of Roszdrav" based on Clincial Hosptial #3 of Saratov State Medical University

location_facility: State Medical Institution " Jursk Regional Clinical Hospital"

location_facility: Institue for Clinical Radiology of the State Establishment "Research Centre for Radiation Medicine of the AMS of Ukraino" Depart of Radiation Psychoneurology

location_facility: Multiple Sclerosis Center Drive, Neurology Suite 701

location_facility: State Educational Institution of Higher Professional Education "Military Medical Academy named after S. M. Korov of Dept of Defense of Russian Federation based on Clinic of Neurology of State Institution

location_facility: State institution Science Research Institute Clinical and Experimental Lymphology of Russian Academy of Medical Sciences

location_facility: MS Center of Brevard MIMA Centry Research Associates

location_facility: Yonsei University Medical Center, Department of Neurology, Yonsei University Medical Center

location_facility: National Cancer Center, Department of Neurology,

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Villa Sofia Hospital Azienda Ospedaliera Villa Sofia P.zza Salerno e Resuttana 1

location_facility: State Educational Institute of Higher Professional Education "I.M. Sechenov Moscow Medical Academy of Roszdrav" Russia based on A. Ya. Kozhevnikov Nervous Disease Clinic

location_facility: Comprehensive MS Care Clinic at South Shore Multiple Sclerosis

location_facility: Azienda Ospedaliera S. Camillo Forlanini

location_facility: Regionsykehuset I Trondheim, Nevrologisk avd.

location_facility: National Neuroscience Institute (TTSH Campus)

location_facility: Universitaetsklinikum und Medizinische Fakultaet Heidelberg

location_facility: State Educational Institute of Higher Professional Education "Rostov State Medical University of Roszdrav"

location_facility: Amrita Institute of Medical Sciences and Research

location_facility: Moscow State Healthcare Institution City Clinical Hospital #11

location_facility: State Healthcare Institution "Kemerovo Regional Clinical Hospital"

location_facility: State Healthcare Institution "Sverdlovsk Regional Clinical Hospital #1"

location_facility: "Dr. Carol Davilla" Military Clinical Hospital

location_facility: Turun Yliopistollinen Keskussairaala Rakennus 3 1

location_facility: Hospital Universitario Nuestra Senora de la Candelaria

location_facility: Fakultní nemocnice s poliklinikou Ostrava

location_facility: St. Petersburg State Healthcare Institution "Multifield City Hospital #2"

location_facility: Hospital for Prevention and Treatment of Cerebro-Vascular Diseases

location_facility: State Medical Institution "Republican Rehabilitation Clinic of Tatarstan Ministry of Health"

location_facility: State Educational Institution of Higher Professional Education "Siberian State Medical University of Roszdrav"

location_facility: Helse Bergen HF Kvinneklinikken Haukeland Universitetssykehus Jonas

location_facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences

location_facility: State Healthcare Institution "Kaluga Regional Hospital"

location_facility: Institute of Human Brain of Russian Academy of Science Dept. of Multiple Sclerosis


title: A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-small Cell Lung Cancer

summary: The purpose of this study is to determine whether progression-free survival with ixabepilone is superior to that achieved with paclitaxel plus carboplatin in participants with advanced nonsmall-cell lung cancer and beta III (βIII)-tubulin-positive tumors.

ReferenceCitation: Edelman MJ, Schneider CP, Tsai CM, Kim HT, Quoix E, Luft AV, Kaleta R, Mukhopadhyay P, Trifan OC, Whitaker L, Reck M. Randomized phase II study of ixabepilone or paclitaxel plus carboplatin in patients with non-small-cell lung cancer prospectively stratified by beta-3 tubulin status. J Clin Oncol. 2013 Jun 1;31(16):1990-6. doi: 10.1200/JCO.2012.45.3282. Epub 2013 Apr 15.

lead_sponsor: R-Pharm

location_country:
Taiwan
Spain
Italy
Russian Federation
Australia
Argentina
Korea, Republic of
United States
France
Germany

location_facility:
Local Institution
Uof Md,Greenebaum Cancer Ctr.
Scripps Cancer Center


title: A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study Evaluating The Efficacy And Safety Of Latanoprost And Timolol In Pediatric Subjects With Glaucoma.

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

location_country:
Poland
Belgium
Portugal
Romania
Italy
Russian Federation
Serbia
Slovenia
Spain
United Kingdom
Ukraine
France
United States
India
South Africa
Colombia
Philippines
Germany
Slovakia
Czechia

summary: To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma.


title: A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study to Evaluate Efficacy and Safety of Prolonged Release (PR) OROS Methylphenidate (54 and 72 mg/Day) in Adults With Attention Deficit/Hyperactivity Disorder

summary: The purpose of this study is to evaluate the efficacy of 2 fixed dosages of Prolonged Release (PR) OROS methylphenidate (54 and 72 mg/day) compared with placebo in adult patients with attention deficit/hyperactivity disorder (ADHD).

lead_sponsor: Janssen-Cilag International NV

location_country:
Denmark
Spain
United Kingdom
Netherlands
Finland
Switzerland
Sweden
France
Belgium
Norway
Germany


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

lead_sponsor: Novo Nordisk A/S

ReferenceCitation: Inbal A, Oldenburg J, Carcao M, Rosholm A, Tehranchi R, Nugent D. Recombinant factor XIII: a safe and novel treatment for congenital factor XIII deficiency. Blood. 2012 May 31;119(22):5111-7. doi: 10.1182/blood-2011-10-386045. Epub 2012 Mar 26.

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.

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

summary: The trial is conducted in Europe, North America and Asia. The aim of this trial is to evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited FXIII deficiency. It is expected that recombinant FXIII can be used for the prevention of bleeding episodes.


title: A Long-Term, Open-Label, Flexible-Dose, Extension Study Evaluating the Safety and Tolerability of Lu AA21004 in Subjects With Major Depressive Disorder

location_country:
Croatia
Poland
Taiwan
Serbia
United Kingdom
Latvia
Russian Federation
Australia
Netherlands
Lithuania
Ukraine
Korea, Republic of
United States
France
Malaysia
South Africa
Germany

summary: The purpose of this study is to determine the long-term efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.


title: A Phase III Open-label Titration Trial to Evaluate the Effectiveness and Safety of Different Doses of a Dermal Application of Testosterone MD-Lotion® (Cutaneous Solution) in Hypogonadal Men

summary: Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product- Testosterone MD-Lotion (cutaneous solution), and this study will evaluate the efficacy via pharmacokinetics of various doses of this product. The study will also assess safety of the product.

ReferenceCitation: Wang C, Ilani N, Arver S, McLachlan RI, Soulis T, Watkinson A. Efficacy and safety of the 2% formulation of testosterone topical solution applied to the axillae in androgen-deficient men. Clin Endocrinol (Oxf). 2011 Dec;75(6):836-43. doi: 10.1111/j.1365-2265.2011.04152.x.

ReferenceCitation: Muram D, Ni X. Utility of a single serum testosterone measurement to determine response to topical testosterone replacement in hypogonadal men. Curr Med Res Opin. 2016;32(2):263-9. doi: 10.1185/03007995.2015.1117434. Epub 2015 Dec 15.

lead_sponsor: Eli Lilly and Company

location_country:
United Kingdom
Australia
United States
France
Sweden
Germany

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.


acronym: ALSYMPCA

title: A Double-blind, Randomised, Multiple Dose, Phase III, Multicentre Study of Alpharadin in the Treatment of Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases

ReferenceCitation: Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fosså SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, Bottomley D, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzén L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland ØS, Sartor O; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18;369(3):213-23. doi: 10.1056/NEJMoa1213755.

ReferenceCitation: Hoskin P, Sartor O, O'Sullivan JM, Johannessen DC, Helle SI, Logue J, Bottomley D, Nilsson S, Vogelzang NJ, Fang F, Wahba M, Aksnes AK, Parker C. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. Lancet Oncol. 2014 Nov;15(12):1397-406. doi: 10.1016/S1470-2045(14)70474-7. Epub 2014 Oct 17.

ReferenceCitation: Sartor O, Coleman R, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fosså SD, Chodacki A, Wiechno P, Logue J, Widmark A, Johannessen DC, Hoskin P, James ND, Solberg A, Syndikus I, Vogelzang NJ, O'Bryan-Tear CG, Shan M, Bruland ØS, Parker C. Effect of radium-223 dichloride on symptomatic skeletal events in patients with castration-resistant prostate cancer and bone metastases: results from a phase 3, double-blind, randomised trial. Lancet Oncol. 2014 Jun;15(7):738-46. doi: 10.1016/S1470-2045(14)70183-4. Epub 2014 May 13.

ReferenceCitation: Delacruz A, Arauz G, Curley T, Lindo A, Jensen T. Nursing management of patients with castration-resistant prostate cancer undergoing radium-223 dichloride treatment. Clin J Oncol Nurs. 2015 Apr;19(2):E31-5. doi: 10.1188/15.CJON.E31-E35.

ReferenceCitation: Humm JL, Sartor O, Parker C, Bruland OS, Macklis R. Radium-223 in the treatment of osteoblastic metastases: a critical clinical review. Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):898-906. doi: 10.1016/j.ijrobp.2014.12.061. Review.

ReferenceCitation: Nilsson S. Alpha-emitter radium-223 in the management of solid tumors: current status and future directions. Am Soc Clin Oncol Educ Book. 2014:e132-9. doi: 10.14694/EdBook_AM.2014.34.e132. Review.

ReferenceCitation: Den RB, Doyle LA, Knudsen KE. Practical guide to the use of radium 223 dichloride. Can J Urol. 2014 Apr;21(2 Supp 1):70-6. Review.

ReferenceCitation: Shirley M, McCormack PL. Radium-223 dichloride: a review of its use in patients with castration-resistant prostate cancer with symptomatic bone metastases. Drugs. 2014 Apr;74(5):579-86. doi: 10.1007/s40265-014-0198-4. Review.

ReferenceCitation: Wissing MD, van Leeuwen FW, van der Pluijm G, Gelderblom H. Radium-223 chloride: Extending life in prostate cancer patients by treating bone metastases. Clin Cancer Res. 2013 Nov 1;19(21):5822-7. doi: 10.1158/1078-0432.CCR-13-1896. Epub 2013 Sep 19. Review.

ReferenceCitation: Joung JY, Ha YS, Kim IY. Radium Ra 223 dichloride in castration-resistant prostate cancer. Drugs Today (Barc). 2013 Aug;49(8):483-90. doi: 10.1358/dot.2013.49.8.1968670.

ReferenceCitation: Parker C, Zhan L, Cislo P, Reuning-Scherer J, Vogelzang NJ, Nilsson S, Sartor O, O'Sullivan JM, Coleman RE. Effect of radium-223 dichloride (Ra-223) on hospitalisation: An analysis from the phase 3 randomised Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) trial. Eur J Cancer. 2017 Jan;71:1-6. doi: 10.1016/j.ejca.2016.10.020. Epub 2016 Dec 6.

location_country:
Poland
Brazil
Hong Kong
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Czech Republic
Sweden
United States
France
Israel
Singapore
Belgium
Norway
Germany
Slovakia

summary: ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases.


title: A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of Talampanel in Subjects With Amyotrophic Lateral Sclerosis (ALS)

acronym: ALS

summary: The purpose of this study is to assess the efficacy, tolerability and safety of oral administration of talampanel compared to a placebo in subjects with ALS.

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Spain
Italy
Netherlands
Canada
Hungary
United States
France
Israel
Belgium
Germany

location_facility: Fondazione "S.Maugeri" Clinica della Riabilitazione IRCCS-Istituto Scientifico di Lissone

location_facility: Berufsgenossenschaftliche Klinik Bergmannsheil, Neurologische Klinik

location_facility: London Health Sciences Centre Motor Neuro Diseases Clinic

location_facility: Hopital La Pitie Salpetriere - Federation de Neurologie

location_facility: Massachusetts General Hospital-Neurology Clinical Trials Unit

location_facility: C.H.U. La Timone - Service de Neurologie

location_facility: University of Kansas Medical Center - Dept of Neurology

location_facility: Semmelweis University, Department of Neurology

location_facility: CA Medical Center for Movement Disorders-Forbes Norris MDA/ALS Research Center

location_facility: Columbia University - Neurology Institute

location_facility: Universitaetsklinik Berlin-Charite, Campus Virchow Klinikum, Neurologische Klinik

location_facility: Azienda Ospedaliero Universitaria San Giovanni Battista di Torino - Dipartimento di Neuroscienze

location_facility: Academic Hospital University of Leuven - ALS dept

location_facility: C.H.U. de Montpellier - Hopital Gui de Chauliac - Service des Explorations Neurologiques

intervention_type: Other


title: Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)

acronym: EchoCRT

summary: The EchoCRT trial evaluates the effects of Cardiac Resynchronization Therapy (CRT) on mortality and morbidity of subjects with heart failure due to left ventricular systolic dysfunction, already receiving optimized HF medication, with a narrow QRS width (< 130 ms) and echocardiographic evidence of ventricular dyssynchrony.

ReferenceCitation: Varma N, Sogaard P, Bax JJ, Abraham WT, Borer JS, Dickstein K, Singh JP, Gras D, Holzmeister J, Brugada J, Ruschitzka F. Interaction of Left Ventricular Size and Sex on Outcome of Cardiac Resynchronization Therapy Among Patients With a Narrow QRS Duration in the EchoCRT Trial. J Am Heart Assoc. 2018 May 27;7(11). pii: e009592. doi: 10.1161/JAHA.118.009592. Erratum in: J Am Heart Assoc. 2018 Jun 17;7(12):.

ReferenceCitation: Tayal B, Gorcsan J 3rd, Bax JJ, Risum N, Olsen NT, Singh JP, Abraham WT, Borer JS, Dickstein K, Gras D, Krum H, Brugada J, Robertson M, Ford I, Holzmeister J, Ruschitzka F, Sogaard P. Cardiac Resynchronization Therapy in Patients With Heart Failure and Narrow QRS Complexes. J Am Coll Cardiol. 2018 Mar 27;71(12):1325-1333. doi: 10.1016/j.jacc.2018.01.042.

ReferenceCitation: Steffel J, Varma N, Robertson M, Singh JP, Bax JJ, Borer JS, Dickstein K, Ford I, Gorcsan J 3rd, Gras D, Krum H, Sogaard P, Holzmeister J, Brugada J, Abraham WT, Ruschitzka F. Effect of Gender on Outcomes After Cardiac Resynchronization Therapy in Patients With a Narrow QRS Complex: A Subgroup Analysis of the EchoCRT Trial. Circ Arrhythm Electrophysiol. 2016 Jun;9(6). pii: e003924. doi: 10.1161/CIRCEP.115.003924.

ReferenceCitation: Ruschitzka F, Abraham WT, Singh JP, Bax JJ, Borer JS, Brugada J, Dickstein K, Ford I, Gorcsan J 3rd, Gras D, Krum H, Sogaard P, Holzmeister J; EchoCRT Study Group. Cardiac-resynchronization therapy in heart failure with a narrow QRS complex. N Engl J Med. 2013 Oct 10;369(15):1395-405. doi: 10.1056/NEJMoa1306687. Epub 2013 Sep 2.

lead_sponsor: Biotronik, Inc.

location_country:
Denmark
Poland
Portugal
Spain
Italy
Austria
Australia
Netherlands
Canada
United Kingdom
Switzerland
United States
France
Israel
Belgium
Germany
Czechia

location_facility: University Hospitals of Coventry and Warwickshire

location_facility: IKEM - Institute for Clinical and Experimental Medicine

location_facility: Jefferson Heart Institute, Thomas Jefferson University Hospital

location_facility: Promedica Northwest Ohio Cardiology Consultants

location_facility: Michigan Heart, P.C./ St. Joseph Mercy Hospital

location_facility: The Ohio State University Richard M. Ross Heart Hospital

location_facility: Thoracic & Cardiovascular Healthcare Foundation

location_facility: Evangelisch-Freikirchliches Krankenhaus und Herzzentrum Brandenburg in Bernau


title: An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects With Giant Cell Tumor of Bone

lead_sponsor: Amgen

ReferenceCitation: Chawla S, Henshaw R, Seeger L, Choy E, Blay JY, Ferrari S, Kroep J, Grimer R, Reichardt P, Rutkowski P, Schuetze S, Skubitz K, Staddon A, Thomas D, Qian Y, Jacobs I. Safety and efficacy of denosumab for adults and skeletally mature adolescents with giant cell tumour of bone: interim analysis of an open-label, parallel-group, phase 2 study. Lancet Oncol. 2013 Aug;14(9):901-8. doi: 10.1016/S1470-2045(13)70277-8. Epub 2013 Jul 16.

ReferenceCitation: Martin-Broto J, Cleeland CS, Glare PA, Engellau J, Skubitz KM, Blum RH, Ganjoo KN, Staddon A, Dominkus M, Feng A, Qian Y, Braun A, Jacobs I, Chung K, Atchison C. Effects of denosumab on pain and analgesic use in giant cell tumor of bone: interim results from a phase II study. Acta Oncol. 2014 Sep;53(9):1173-9. doi: 10.3109/0284186X.2014.910313. Epub 2014 May 19.

ReferenceCitation: Rutkowski P, Ferrari S, Grimer RJ, Stalley PD, Dijkstra SP, Pienkowski A, Vaz G, Wunder JS, Seeger LL, Feng A, Roberts ZJ, Bach BA. Surgical downstaging in an open-label phase II trial of denosumab in patients with giant cell tumor of bone. Ann Surg Oncol. 2015 Sep;22(9):2860-8. doi: 10.1245/s10434-015-4634-9. Epub 2015 Jun 2.

ReferenceCitation: Chawla S, Blay JY, Rutkowski P, Le Cesne A, Reichardt P, Gelderblom H, Grimer RJ, Choy E, Skubitz K, Seeger L, Schuetze SM, Henshaw R, Dai T, Jandial D, Palmerini E. Denosumab in patients with giant-cell tumour of bone: a multicentre, open-label, phase 2 study. Lancet Oncol. 2019 Dec;20(12):1719-1729. doi: 10.1016/S1470-2045(19)30663-1. Epub 2019 Nov 6.

ReferenceCitation: Engellau J, Seeger L, Grimer R, Henshaw R, Gelderblom H, Choy E, Chawla S, Reichardt P, O'Neal M, Feng A, Jacobs I, Roberts ZJ, Braun A, Bach BA. Assessment of denosumab treatment effects and imaging response in patients with giant cell tumor of bone. World J Surg Oncol. 2018 Sep 19;16(1):191. doi: 10.1186/s12957-018-1478-3.

ReferenceCitation: Bukata SV, Blay JY, Rutkowski P, Skubitz K, Henshaw R, Seeger L, Dai T, Jandial D, Chawla S. Denosumab Treatment for Giant Cell Tumor of the Spine Including the Sacrum. Spine (Phila Pa 1976). 2021 Mar 1;46(5):277-284. doi: 10.1097/BRS.0000000000003728.

ReferenceCitation: Palmerini E, Seeger LL, Gambarotti M, Righi A, Reichardt P, Bukata S, Blay JY, Dai T, Jandial D, Picci P. Malignancy in giant cell tumor of bone: analysis of an open-label phase 2 study of denosumab. BMC Cancer. 2021 Jan 22;21(1):89. doi: 10.1186/s12885-020-07739-8.

ReferenceCitation: Uday S, Gaston CL, Rogers L, Parry M, Joffe J, Pearson J, Sutton D, Grimer R, Högler W. Osteonecrosis of the Jaw and Rebound Hypercalcemia in Young People Treated With Denosumab for Giant Cell Tumor of Bone. J Clin Endocrinol Metab. 2018 Feb 1;103(2):596-603. doi: 10.1210/jc.2017-02025.

ReferenceCitation: van der Heijden L, van de Sande MA, Hogendoorn PC, Gelderblom H, Dijkstra PD. Neoadjuvant denosumab for extensive giant cell tumor in os ischium: a case report. Acta Orthop. 2015 Jun;86(3):393-5. doi: 10.3109/17453674.2014.1002345. Epub 2015 Feb 14.

location_country:
Poland
Spain
Italy
Austria
Australia
Netherlands
Canada
United Kingdom
Sweden
United States
France
Germany

summary: To determine how safe denosumab is in treating subjects with giant cell tumor of bone (GCTB)


acronym: 48-week comparison of Tiotropium/Salmeterol Inhalation Powder with the individual components

title: 1-yr Study Comparing TioSal Combo Regimens Versus Single Agent Therapies (Spiriva HandiHaler and Salmeterol PE Capsule)

lead_sponsor: Boehringer Ingelheim

location_country:
Denmark
Italy
Austria
Estonia
Latvia
Canada
Finland
Lithuania
Netherlands
Sweden
Hungary
Korea, Republic of
United States
France
South Africa
Germany
Slovakia

location_facility: 1184.15.01052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01064 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01057 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.45052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01055 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.49057 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.3352A Boehringer Ingelheim Investigational Site

location_facility: 1184.15.82052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.46051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02058 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.43053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.36052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01069 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02060 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02056 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.36053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.36054 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.3350A Boehringer Ingelheim Investigational Site

location_facility: 1184.15.35851 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.37053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01063 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01059 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.37252 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01058 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.37251 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.49056 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.36055 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01062 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01065 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02059 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.42153 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.37152 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.31052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.31054 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02057 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.46053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01070 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.82051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.39051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.31051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01054 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.37154 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.37153 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.82053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.45051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.35852 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02055 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.49053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.45054 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.49058 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.43052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.45053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.3351A Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01072 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.42154 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.49052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01071 Boehringer Ingelheim Investigational Site

summary: The primary objectives of this study are to assess bronchodilator efficacy as determined by FEV1, the effect on dyspnoea as determined by the BDI/TDI, the effect on health status as determined bt the SGRQ and the effect on COPD exacerbations