A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY

• Conditions: Treatment of pulmonary arterial hypertension (PAH) in patients with grade II modified NYHA; MedDRA version: 14.1Level: PTClassification code 10037400Term: Pulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2004-000478-30-IT
• Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-11
• Last Update Posted: 10 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

· PAH in modified NYHA functional class II due to:- PAH idiopathic (Primary Pulmonary Hypertension)- PAH secondary to human immunodeficiency virus (HIV)- PAH secondary to anorexigens- PAH secondary to atrial septum defect (ASD) < 2 cm, ventricular septum defect (VSD) < 1 cm or patent ductus arteriosus (PDA)- PAH secondary to connective tissue or auto-immune diseases· 6-minute walk test (6MWT) distance < 80% of normal predicted value, or < 500 m associated with Borg dyspnea index score of ³2 points
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

· PAH associated with conditions other than those mentioned above, e.g., PAH secondary to portal hypertension, complex congenital heart disease or reverse shunt· Severe obstructive lung disease: FEV1/FVC < 0.5· Total lung capacity < 80% of normal predicted value· Significant vasoreactivity during right heart catheterization: i.e., a fall in mPAP to < 40 mmHg with a decrease ³ 10 mmHg and with a normal cardiac index (³ 2.5 l/min.m2)· Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements (in particular with 6MWT)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that bosentan improves cardiac hemodynamics and, as subordinate, exercise capacity in mildly symptomatic PAH patients;Secondary Objective: To evaluate the effect of bosentan on time to clinical worsening, dyspnea, NYHA Class, and quality of life.;Primary end point(s): · PVR at rest at EOS expressed as percent of baseline value. A geometric mean in the active group showing a reduction of at least 20% when compared to the placebo geometric mean is considered clinically relevant.