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 South Alabama
🇺🇸Mobile, Alabama, United States
Arizona Pulmonary Specialists
🇺🇸Phoenix, Arizona, United States
VA Greater LA Healthcare System
🇺🇸Los Angeles, California, United States
University of California San Diego Medical Center
🇺🇸San Diego, California, United States
Harish H. K. Murthy, MD
🇺🇸San Jose, California, United States
UCLA Medical Center
🇺🇸Torrance, California, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Cleveland Clinic
🇺🇸Ft. Lauderdale, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Scroll for more (46 remaining)University of South Alabama🇺🇸Mobile, Alabama, United States