drugset / Trial / NCT00832507
Study of Cicletanine for Pulmonary Arterial Hypertension (PAH)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cicletanine | Small molecule | 150 mg | Oral |
| Subject | Cicletanine | Small molecule | 300 mg | Oral |