Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension

Phase 3

Completed

• Conditions: Pulmonary Hypertension

• Registration Number: NCT00159887
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

Open label extension study to the pivotal efficacy study to assess the safety of sildenafil citrate in patients with pulmonary arterial hypertension

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-12
• Study Completion: 2007-02
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• Patients with PAH who had completed the 12 week pivotal study

Exclusion Criteria

• Any other patients with PAH that had not been included into the pivotal study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
WHO Functional Class
Quality of Life SF-36 and EQ-5D
Safety
Standard safety data
Efficacy
6-Minute Walk Test
BORG Dyspnoea Score

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Glasgow, United Kingdom