Trials / Completed
CompletedNCT00319111
Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Long-term Open-label Extension Study in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Who Completed Protocol AC-052-366 (BENEFIT, NCT00313222)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 151 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The present trial investigates the long-term safety, tolerability and efficacy of bosentan in patients with inoperable CTEPH.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | bosentan | Oral bosentan * Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients * Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight \< 40 kg) |
Timeline
- Start date
- 2006-01-01
- Primary completion
- 2009-02-01
- Completion
- 2009-04-01
- First posted
- 2006-04-27
- Last updated
- 2025-02-04
- Results posted
- 2012-12-31
Source: ClinicalTrials.gov record NCT00319111. Inclusion in this directory is not an endorsement.