Status:
TERMINATED
To Assess The Efficacy and Safety Of Oral Sildenafil 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 demonstrate a dose response for 1 mg, 5 mg and 20 mg TID oral sildenafil for the treatment of subjects with PAH.
Eligibility Criteria
Inclusion
- Subjects with PAH (i.e. IPAH or secondary to connective tissue disease or with surgical repair of ASD, VSD, PDA, aorto-pulmonary window) whose baseline six minute walk test distance is \>/= 100 m and \</= 450 m.
- Subjects with a mean pulmonary artery pressure of \>/= 25 mmHg and a pulmonary artery wedge pressure of \</= 15 mmHg at rest via right heart catheterization performed within 12 weeks prior to randomization.
Exclusion
- Subjects whose 6 Minute Walk Distance may be limited by conditions other than PAH related dyspnoea or fatigue, e.g. claudication from vascular insufficiency or significant arthritis.
- Subjects who are currently receiving any forms of chronic treatment for PAH such as prostacyclin, PDE-5 inhibitors, endothelin-receptor antagonists, nitrates or nitric oxide donors (e.g. arginine supplement, nicorandil) in any form, protease inhibitors such as ritonavir and saquinavir, ketoconazole, itraconazole, and alpha blockers. Subjects previously receiving any of these drugs must have stopped use for a period of at least 1 month prior to screening, except in the case of bosentan or prostacyclin (3 months).
Key Trial Info
Start Date :
April 8 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2010
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00430716
Start Date
April 8 2008
End Date
May 25 2010
Last Update
December 22 2020
Active Locations (46)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Pulmonary Specialists, LTD
Phoenix, Arizona, United States, 85013
2
Medical College of Georgia
Augusta, Georgia, United States, 30912
3
Atlanta Institute for Medical Research, Inc.
Decatur, Georgia, United States, 30030
4
Chicago Heart Institute
Elk Grove Village, Illinois, United States, 60007