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).

An open label, observational, practice based, non-comparative, multicenter, prospective, active surveillance to evaluate the safety and tolerability of Bosentan 62.5mg/125mg oral tablets in patients with Pulmonary Arterial Hypertension (PAH) [WHO Group I].

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/04/042308

Enrollment

150

Registered

2022-04-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I119- Hypertensive heart disease withoutheart failure

Interventions

Intervention1: Non Interventional study: Not applicable Control Intervention1: Not applicable: Not applicable Control Intervention2: No comparator: Not applicable

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability endpoints: Adverse events PAH worsening events Adverse events and relevant abnormal laboratory findings (serious/ non-serious, expected/ unexpected, related/ non-related) Adverse Events of special interest Percentage of patient s with overall adverse events Percentage of patient s requiring dose reductions Treatment discontinuation rates: Early discontinuation, discontinuation due to adverse eventsTimepoint: safety will be monitored throughout the study duration. however visits are planned at screening, 12 weeks and 24 weeks.	—

Measure

Time frame

Safety and tolerability endpoints: Adverse events PAH worsening events Adverse events and relevant abnormal laboratory findings (serious/ non-serious, expected/ unexpected, related/ non-related) Adverse Events of special interest Percentage of patient s with overall adverse events Percentage of patient s requiring dose reductions Treatment discontinuation rates: Early discontinuation, discontinuation due to adverse eventsTimepoint: safety will be monitored throughout the study duration. however visits are planned at screening, 12 weeks and 24 weeks.

—

Secondary

Measure	Time frame
Not applicableTimepoint: Not applicable	—

Countries

India

Contacts

Public ContactMr Abhijit Vaidya

Cipla Ltd

Sandesh.Sawant3@cipla.com02223025999

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026