Evaluation of the safety of macitentan in patients with pulmonary hypertension due to left heart failure.

• Conditions: Combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left ventricular dysfunction.; MedDRA version: 16.1Level: LLTClassification code 10024106Term: Left heart failureSystem Organ Class: 100000004849; MedDRA version: 16.1Level: PTClassification code 10037400Term: Pulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-003822-96-AT
• Lead Sponsor: Actelion Pharmaceuticals Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-15
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Males and Females >=18 years of age
2. Subjects with combined pre-and post-capillary Pulmonary Hypertension (CpcPH) due to left ventricular dysfunction (subset of WHO groups 2.1 and 2.2)
3. Optimized diuretic therapy
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Types of Pulmonary Hypertension other than WHO groups 2.1 and 2.2 (Nice classification)
2. Administration of PAH-specific therapy (i.e., Endothelin receptor antagonists (ERAs), Prostanoids, Phosphodiesterase 5 (PDE-5) inhibitors, guanylate cyclase stimulators)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified