Status:
COMPLETED
Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To assess the efficacy and safety of sildenafil when added to patients with PAH who are taking bosentan as all or part of their background therapy.
Eligibility Criteria
Inclusion
- Subjects aged 18 and over above with PAH and for which bosentan therapy is indicated according to national license
- Subjects with a mean pulmonary artery pressure of \>25mmHg and a pulmonary artery wedge pressure of \<15mmHg at rest via right heart catheterization within 3 years prior to randomization.
- Subjects whose baseline 6 Minute Walk Test distance is \>100m and \< 450m.
Exclusion
- PAH secondary to any aetiology including congenital heart disease other than those specified in the inclusion criteria
- Subjects whose 6 Minute Walk Test may be limited by conditions other than PAH related dyspnoea or fatigue eg. claudication from vascular insufficiency or arthritis.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00323297
Start Date
September 1 2006
End Date
August 1 2013
Last Update
February 1 2021
Active Locations (30)
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1
West Los Angeles VA Healthcare, Pulmonary Hypertension Program
Los Angeles, California, United States, 90073
2
Henry Ford Hospital
Detroit, Michigan, United States, 48202
3
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
4
Baylor College of Medicine
Houston, Texas, United States, 77030