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Cicletanine 150 mg BID for Pulmonary Arterial Hypertension

Phase 2
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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.

Eligible Conditions
  • Pulmonary Arterial Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Cicletanine 300 mg QDExperimental Treatment1 Intervention
Cicletanine 300 mg administered once daily (QD)
Group II: Cicletanine 150 mg QDExperimental Treatment1 Intervention
Cicletanine 150 mg administered once daily (QD)
Group III: Cicletanine 150 mg BIDExperimental Treatment1 Intervention
Cicletanine 150 mg administered twice daily (BID)
Group IV: PlaceboPlacebo Group2 Interventions
Placebo to match cicletanine administered once daily

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Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,126 Previous Clinical Trials
866,161 Total Patients Enrolled
15 Trials studying Pulmonary Arterial Hypertension
2,767 Patients Enrolled for Pulmonary Arterial Hypertension
Gennyne Walker, PhDStudy ChairSenior Clinical Research Scientist, Gilead Sciences
~10 spots leftby Oct 2025
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