Overview

A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension

Status:
Completed

Trial end date:
2003-11-01

Target enrollment:

Participant gender:

Summary

To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day [TID]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. To investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (PK) parameters.

Phase:

Phase 3

Details

Lead Sponsor:

Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatments:

Sildenafil Citrate