To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.

NCT00430716 ↗

Phase 4 Terminated 130 enrolled Viatris Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

To demonstrate a dose response for 1 mg, 5 mg and 20 mg TID oral sildenafil for the treatment of subjects with PAH.

Timeline

Start: 2008-04-08
Primary completion: 2010-05-25
Completion: 2010-05-25

Outcome

Mixed primary results

Stopped: “This study was terminated at the recommendation of an independent Data Monitoring Committee. The decision was not based on any safety concerns.”

paper At week 12, 6MWD change from baseline was significantly greater for sildenafil 20 versus 1 mg (P = 0.011) but not versus 5 mg. PMID 28228114 ↗

Publications

Vizza CD, Sastry BK, Safdar Z, Harnisch L, Gao X, Zhang M, Lamba M, Jing ZC. Efficacy of 1, 5, and 20 mg oral sildenafil in the treatment of adults with pulmonary arterial hypertension: a randomized, double-blind study with open-label extension. BMC Pulm Med. 2017 Feb 23;17(1):44. doi: 10.1186/s12890-017-0374-x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sildenafil	Unknown	1 mg	Oral
Subject	Sildenafil	Unknown	5 mg	Oral
Subject	Sildenafil	Unknown	20 mg	Oral