The Efficacy and Safety of Vardenafil in the Treatment of Pulmonary Arterial Hypertension

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of vardenafil in the treatment of pulmonary arterial hypertension.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tongji University
• Treatments: Vardenafil Dihydrochloride

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.