This is a research study to check how safe and tolerable Bosentan on patients of Pulmonary arterial hypertension (Increase in pressure of blood vessels of the lungs).
Phase 4
- Conditions
- Health Condition 1: I119- Hypertensive heart disease withoutheart failure
- Registration Number
- CTRI/2022/04/042308
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. A written, signed, dated and ethics committee approved
informed consent form (data sharing consent) from patient
and/or legally acceptable representatives
2. Either male or female of age 12 years and above
3. Patient with the confirmed diagnosis of PAH (Group I)
with WHO Class III to IV symptoms
Exclusion Criteria
1. Contraindications to Bosentan or any of its components
2. Hypersensitivity to Bosentan or any of its components
3. Pregnancy and/or breastfeeding
4. Co-administration of drugs such as Cyclosporine A or
Glyburide
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method