Status:
COMPLETED
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
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 tolerabilit...
Eligibility Criteria
Inclusion
- Included patients had primary pulmonary arterial hypertension, pulmonary hypertension secondary to connective tissue disease, or pulmonary hypertension with surgical repair at least 5 years previously; a mean pulmonary artery pressure greater than or equal to 25 mmHg and a pulmonary artery wedge pressure of less than or equal to 15 mmHg at rest, via right heart catheterisation within 21 days prior to randomisation; and a baseline 6-Minute Walk test distance of 100 m to 450 m.
Exclusion
- Subjects with congenital heart disease, pulmonary hypertension due to thromboembolism, HIV, chronic obstructive airway disease, congestive heart failure or schistosomiasis; subjects with significant (ie \> 2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation; and acutely decompensated heart failure within the previous 30 days; subjects with pulmonary hypertension secondary to any other etiology other than those specified in the inclusion criteria.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2003
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT00644605
Start Date
October 1 2002
End Date
November 1 2003
Last Update
February 1 2021
Active Locations (68)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
2
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294-0006
3
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
4
Pfizer Investigational Site
La Jolla, California, United States, 92037