Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II - Tabular View

Tracking Information
First Received Date ^ICMJE	September 16, 2004
Last Updated Date	October 21, 2009
Start Date ^ICMJE	April 2004
Primary Completion Date	November 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 27, 2008)	exercise capacity [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ] cardiac hemodynamics [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	exercise capacity cardiac hemodynamics
Change History	Complete list of historical versions of study NCT00091715 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II
Official Title ^ICMJE	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 (PAH)
Brief Summary	The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to patients suffering from PAH Class II.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Pulmonary Hypertension
Intervention ^ICMJE	Drug: bosentan Drug: placebo
Study Arms / Comparison Groups	Experimental: 62.5 mg table twice a day for 4 weeks followed by 125 mg tablet twice a day for 6 months followed by an open label period until end of study. Placebo Comparator: placebo for 6 months followed by an open label period
Publications *	Galiè N, Rubin Lj, Hoeper M, Jansa P, Al-Hiti H, Meyer G, Chiossi E, Kusic-Pajic A, Simonneau G. Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial. Lancet. 2008 Jun 21;371(9630):2093-100.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	185
Estimated Completion Date	January 2011
Primary Completion Date	November 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: PAH NYHA Class II Significant elevation of mean pulmonary arterial pressure Significant elevation of pulmonary vascular resistance at rest Limited 6-minute walk distance Exclusion Criteria: PAH secondary to portal hypertension, complex congenital heart disease or reverse shunt Restrictive or obstructive lung disease Significant vasoreactivity Treatments for PAH (within 4 weeks of randomization)
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Australia, Austria, Belgium, Canada, China, Czech Republic, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00091715
Responsible Party	Sponsor, Actelion
Study ID Numbers ^ICMJE	EARLY, AC-052-364
Study Sponsor ^ICMJE	Actelion
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Actelion
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP