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Study of Cicletanine for Pulmonary Arterial Hypertension (PAH)

NCT00832507 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2014-02-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cicletanine

Cicletanine capsules 150 mg or 300 mg administered orally once or twice daily

DRUG

Cicletanine Placebo

Placebo to match cicletanine administered orally once daily, followed by active cicletanine in the blinded extension period

Sponsors & Collaborators

Principal Investigators

  • Gennyne Walker, PhD · Senior Clinical Research Scientist, Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-10-31
Completion
2012-03-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Germany
  • Israel
  • Mexico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00832507 on ClinicalTrials.gov