Phase 3
N=151
Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Pulmonary Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00319111 ↗Enrolled (actual)
151
Serious AEs
33.8%
Results posted
Dec 2012
Primary outcome: Primary: Change From Baseline to All Assessed Time Points in 6-minute Walk Test (6MWT) Distance — 8.4; 18.2; 17.7; 20.2 walk distance change from baseline (m)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- bosentan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Actelion
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to All Assessed Time Points in 6-minute Walk Test (6MWT) Distance |
8.4; 18.2; 17.7; 20.2; 16.9 | — |
| PRIMARY Change From Baseline to All Assessed Time Points in Borg Dyspnea Index |
-0.5; -0.4; -0.1; -0.1; -0.2 | — |
| PRIMARY Disease Severity - Number of Patients Showing Improvement by One Class or More in World Health Organisation (WHO) Functional Classification of Pulmonary Hypertension (PH) |
26; 30; 33; 33; 30 | — |
| PRIMARY Time to Clinical Worsening up to End-of-study |
11; 8; 18; 11; 25; 15 | — |
| SECONDARY Number of Patients With an Adverse Event(s) Leading to Premature Discontinuation of Study Medication |
28 | — |
| SECONDARY Number of Patients Experiencing a Serious Adverse Event(s) up to 28 Days After Study Medication Discontinuation |
51 | — |
| SECONDARY Occurrence of Liver Function Test and Hemoglobin Abnormality |
27; 9 | — |
Summary
The present trial investigates the long-term safety, tolerability and efficacy of bosentan in patients with inoperable CTEPH.
Eligibility Criteria
Inclusion Criteria
- Patients having completed the 16-week treatment period of protocol AC-052-366 (NCT00313222)
- Signed informed consent
Exclusion Criteria
- Any major violation of protocol AC-052-366 (NCT00313222)
- Pregnancy or breast-feeding
Data sourced from ClinicalTrials.gov (NCT00319111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.