Tezosentan in Patients With Pulmonary Arterial Hypertension
Phase 2
Terminated
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Other: Placebo
- Registration Number
- NCT01094067
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Brief Summary
Multicenter, double-blind, randomized, placebo-controlled, cross-over study to demonstrate that a single infusion of tezosentan has minimal effect on blood pressure in patients with pulmonary arterial hypertension, treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or a combination of both.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Placebo Placebo at visit 1, tezosentan at visit 2 2 ACT-050089 Tezosentan at visit 1, placebo at visit 2 2 Placebo Tezosentan at visit 1, placebo at visit 2 1 ACT-050089 Placebo at visit 1, tezosentan at visit 2
- Primary Outcome Measures
Name Time Method Absolute change in supine SBP from Baseline to 30 minutes at each visit (Visit 1 and Visit 2) - in mmHg 30 days
- Secondary Outcome Measures
Name Time Method Absolute change in heart rate from Baseline to 30 minutes at each visit (Visit 1 and Visit 2) - in bpm 30 days
Trial Locations
- Locations (5)
Baylor College of Medicine
🇺🇸Houston, Texas, United States
National Cardiovascular Center
🇯🇵Osaka, Japan
Hopital Antoine Beclere
🇫🇷Clamart, France
Osaka University Hospital
🇯🇵Osaka, Japan
Keio University Hospital
🇯🇵Shinjuku-Ku, Japan