ong-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
- Conditions
- MedDRA version: 21.1Level: LLTClassification code 10068739Term: Chronic thromboembolic pulmonary hypertensionSystem Organ Class: 100000004855Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2013-003457-25-BE
- Lead Sponsor
- Actelion Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 78
Subject with CTEPH having completed the double-blind (DB) AC-055E201 / MERIT-1 study as scheduled (i.e., who remained in the DB study up to Week 24).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 47
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 31
- Permanent discontinuation of DB study treatment due to an hepatic adverse event or liver aminotransferase abnormalities.
- Any known factor (e.g., drug or substance abuse) or disease (e.g., unstable psychiatric illness) that, in the opinion of the investigator, may interfere with treatment compliance or interpretation of the results, or that may influence the ability to comply with any of the study requirements.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To evaluate the long-term safety and tolerability of macitentan 10 mg in subjects with inoperable CTEPH<br>- To evaluate the long term effects of macitentan 10 mg on exercise capacity and functional class (FC).;Secondary Objective: Not Applicable;Primary end point(s): Evaluation of the long-term safety and tolerability:<br>- Treatment-emergent AEs up to 30 days after study drug<br>discontinuation.<br>- AEs leading to premature discontinuation of study drug.<br>- Treatment-emergent SAEs up to 30 days after study drug<br>discontinuation.<br>- Treatment-emergent marked laboratory abnormalities up to 30 days<br>after study drug discontinuation.<br>- Change in vital signs (blood pressure , heart rate) and body weight<br>from baseline to all assessed time points during the study;Timepoint(s) of evaluation of this end point: From baseline up to 30 days after study drug discontinuation
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change from baseline to each scheduled time point in exercise capacity,<br>as measured by the 6MWD;Timepoint(s) of evaluation of this end point: Baseline up to 30 months