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

• Register: EUCTR
• Last refreshed on: 10 December 2012
• Main ID: EUCTR2004-000478-30-IT
• Date of registration: 11/07/2007
• Prospective Registration: No
• Primary sponsor: Actelion Pharmaceuticals Ltd
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 09/09/2004
• Target sample size: 170
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000478-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Czech Republic, Denmark, Italy, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

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)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Treatment of pulmonary arterial hypertension (PAH) in patients with grade II modified NYHA
MedDRA version: 14.1 Level: PT Classification code 10037400 Term: Pulmonary hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Trade Name: TRACLEER*56CPR RIV 125MG
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Bosentan
Concentration unit: mg milligram(s)
Concentration number: 125-

Primary Outcome(s)

Secondary Objective: To evaluate the effect of bosentan on time to clinical worsening, dyspnea, NYHA Class, and quality of life.

Main Objective: To demonstrate that bosentan improves cardiac hemodynamics and, as subordinate, exercise capacity in mildly symptomatic PAH patients

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.

Secondary ID(s)

2004-000478-30-SE

AC-052-364(EARLY)