Status:
COMPLETED
The Efficacy and Safety of Vardenafil in the Treatment of Pulmonary Arterial Hypertension
Lead Sponsor:
Tongji University
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
12-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of vardenafil in the treatment of pulmonary arterial hypertension.
Detailed Description
Pulmonary arterial hypertension (PAH), defined as a mean pulmonary artery pressure ≥25 mmHg with a pulmonary capillary wedge pressure ≤15 mmHg measured by cardiac catheterization, is a disorder that m...
Eligibility Criteria
Inclusion
- Subjects aged 12-65.
- Confirmed idiopathic pulmonary hypertension, connective tissue disease associated pulmonary hypertension, congenital heart disease(with Eisenmenger syndrome) associated pulmonary hypertension.
- Baseline 6-minutes walking distance 150m-550m.
- WHO pulmonary hypertension function II-III with non-responder to calcium channel blockers.
- Documented written informed consent.
Exclusion
- The other types of pulmonary hypertension.
- Subjects who refuse to subscribe written informed consents or can't cooperate with the trial well.
- Subjects with serious acute or chronic disease involved liver, kidney, and brain or have to use potent CYP3A4-inhibitor or nitrate to treat the underlying diseases.
- Subjects who are currently treated with sildenafil for PAH or taking sildenafil or tadalafil.
- Other contraindications in package insert.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00718952
Start Date
July 1 2008
End Date
February 1 2010
Last Update
February 12 2010
Active Locations (10)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
2
Peking University First Hospital
Beijing, Beijing Municipality, China, 100043
3
Peking Union Hospital, Peking Union Medical College
Beijing, Beijing Municipality, China, 100730
4
Beijing Shijitan Hospital, Peking University
Beijing, Beijing Municipality, China