drugset / Trial / NCT00832507

Study of Cicletanine for Pulmonary Arterial Hypertension (PAH)

NCT00832507

Phase 2 Terminated 162 enrolled Gilead Sciences
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2009-01
Primary completion
2011-10
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Cicletanine Small molecule 150 mg Oral
Subject Cicletanine Small molecule 300 mg Oral