A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects With Pulmonary Arterial Hypertension
Overview
- Phase
- Phase 2
- Intervention
- Cicletanine
- Conditions
- Pulmonary Arterial Hypertension
- Sponsor
- Gilead Sciences
- Enrollment
- 162
- Locations
- 56
- Primary Endpoint
- Change from baseline in six-minute walk distance (6MWD) evaluated after 12 weeks of treatment
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cicletanine 150 mg QD
Cicletanine 150 mg administered once daily (QD)
Intervention: Cicletanine
Cicletanine 150 mg BID
Cicletanine 150 mg administered twice daily (BID)
Intervention: Cicletanine
Cicletanine 300 mg QD
Cicletanine 300 mg administered once daily (QD)
Intervention: Cicletanine
Placebo
Placebo to match cicletanine administered once daily
Intervention: Cicletanine
Placebo
Placebo to match cicletanine administered once daily
Intervention: Cicletanine Placebo
Outcomes
Primary Outcomes
Change from baseline in six-minute walk distance (6MWD) evaluated after 12 weeks of treatment
Time Frame: Baseline to Week 12
Secondary Outcomes
- 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)