Study of Cicletanine for Pulmonary Arterial Hypertension (PAH)
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Registration Number
- NCT00832507
- Lead Sponsor
- Gilead Sciences
- Brief Summary
This Phase 2, randomized, double-blind, placebo-controlled, multicenter, dose-ranging study will compare the efficacy, safety, and tolerability of cicletanine hydrochloride (HCl) to placebo in subjects with PAH. Study drug will be administered alone, or on the background of stable PAH therapy. The study will consist of 3 periods: a screening period, a 12-week placebo-controlled treatment period, and a long-term, blinded extension period.
- Detailed Description
The primary objective of this study is to compare the change in exercise capacity following treatment with cicletanine HCl or placebo in subjects with PAH.
The secondary objectives of this study are:
1. To compare the change in other clinical measures of PAH following treatment with cicletanine HCl or placebo in subjects with PAH
2. To compare the safety and tolerability of cicletanine HCl to placebo in subjects with PAH Additionally, the long-term safety, tolerability, and efficacy of cicletanine HCl treatment will be evaluated.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 162
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Cicletanine Placebo to match cicletanine administered once daily Cicletanine 150 mg BID Cicletanine Cicletanine 150 mg administered twice daily (BID) Cicletanine 300 mg QD Cicletanine Cicletanine 300 mg administered once daily (QD) Cicletanine 150 mg QD Cicletanine Cicletanine 150 mg administered once daily (QD) Placebo Cicletanine Placebo Placebo to match cicletanine administered once daily
- Primary Outcome Measures
Name Time Method Change from baseline in six-minute walk distance (6MWD) evaluated after 12 weeks of treatment Baseline to Week 12
- Secondary Outcome Measures
Name Time Method Change from baseline in BDI, WHO Functional Class, BNP, cardiac hemodynamics and SF-36 physical functioning scale following 12 weeks of treatment. In addition, time to clinical worsening (TTCW) will be evaluated. Baseline to Week 60
Trial Locations
- Locations (56)
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
The Lindner Clinical Trial Center
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Ft. Lauderdale, Florida, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Louisiana State University
🇺🇸New Orleans, Louisiana, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Tufts-New England Medical Center
🇺🇸Boston, Massachusetts, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Universitaetsklinikum Giessen und Marburg
🇩🇪Giessen, HE, Germany
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Rabin Medical Center
🇮🇱Petach Tikva, Israel
Unidad de Investigación Clínica en Medicina S.C.
🇲🇽Monterrey, NL, Mexico
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Cornell University
🇺🇸New York, New York, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
University of Florida
🇺🇸Gainesville, Florida, United States
VA Greater LA Healthcare System
🇺🇸Los Angeles, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
University of South Alabama
🇺🇸Mobile, Alabama, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Rochester
🇺🇸Rochester, New York, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
UCLA Medical Center
🇺🇸Torrance, California, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Boston University School of Medicine
🇺🇸Boston, Massachusetts, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
University of Chicago Hospital
🇺🇸Chicago, Illinois, United States
Case Medical Center
🇺🇸Cleveland, Ohio, United States
Arizona Pulmonary Specialists
🇺🇸Phoenix, Arizona, United States
Harish H. K. Murthy, MD
🇺🇸San Jose, California, United States
University of California San Diego Medical Center
🇺🇸San Diego, California, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
HU 12 de Octubre
🇪🇸Madrid, Spain
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Ludwig-Maximilians-Universitaet
🇩🇪Muenchen, BY, Germany
Instituto Nacional de Cardiologia Ignacio Chavez
🇲🇽Mexico City, Mexico
Davis Heart and Lung Research Institute
🇺🇸Columbus, Ohio, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
University Klinik Graz
🇦🇹Graz, Austria
Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
University Of Virginia
🇺🇸Charlottesville, Virginia, United States
H Clinic i Provincial
🇪🇸Barcelona, Spain
University Klinik Wien
🇦🇹Wien, Austria
ULB Hôpital Erasme
🇧🇪Bruxelles, Belgium
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
St Vincent's Hospital
🇦🇺Darlinghurst, New South Wales, Australia
Peter Lougheed Centre
🇨🇦Calgary, Alberta, Canada
Royal Free Hospital
🇬🇧London, Gt Lon, United Kingdom
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States