Status:
COMPLETED
To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 Weeks
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to provide sildenafil therapy to eligible adult patients with pulmonary arterial hypertension (PAH) and to the patients who completed the A1481142 study for the treatment ...
Eligibility Criteria
Inclusion
- Subjects aged 18 and over who have any of the following conditions:
- Idiopathic pulmonary arterial hypertension.
- PAH associated with connective tissue disease (CTD).
- PAH with surgical repair, at least 5yrs previously, of atrial septal defect (ASD), ventricular septal defect (VSD) patent ductus arteriosis (PDA) or aorta-pulmonary window.
- Subjects with a mean pulmonary artery pressure (mPAP) \> 25mmHg and a pulmonary artery wedge pressure (PAWP) \< 15mmHg at rest, assessed via right heart catheterization.
- Subjects whose baseline 6-min walk test distance was \> 100m and \< 450m.
Exclusion
- PAH secondary to any etiology other than those specified in the inclusion criteria.
- Subjects with congenital heart disease (other than those specified in the inclusion criteria), PAH due to thrombo-embolism, HIV, chronic obstructive airways disease, congestive heart failure.
- Subjects whose 6-Minute Walk test might have been limited by conditions other than PAH, associated dyspnea or fatigue.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00946114
Start Date
June 1 2006
End Date
March 1 2009
Last Update
February 1 2021
Active Locations (2)
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1
Pfizer Investigational Site
Warsaw, Poland, 01-138
2
Pfizer Investigational Site
Zabrze, Poland, 41-800