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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00091715




Registration number
NCT00091715
Ethics application status
Date submitted
16/09/2004
Date registered
20/09/2004
Date last updated
30/08/2011

Titles & IDs
Public title
Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II
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 (PAH)
Secondary ID [1] 0 0
AC-052-364
Secondary ID [2] 0 0
EARLY
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - bosentan
Treatment: Drugs - placebo

Experimental: 1 - 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: 2 - placebo for 6 months followed by an open label period


Treatment: Drugs: bosentan
65 mg tablet twice a day for 4 weeks followed by 125 mg tablet twice a day until end of study

Treatment: Drugs: placebo
placebo for 6 months followed by an open-label period
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
exercise capacity
Timepoint [1] 0 0
Baseline to end of study
Primary outcome [2] 0 0
cardiac hemodynamics
Timepoint [2] 0 0
Baseline to end of study

Eligibility
Key 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
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2011
Sample size
Target
Accrual to date
Final
185
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [2] 0 0
Royal Prince Albert Hospital - Camperdown
Recruitment hospital [3] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment postcode(s) [1] 0 0
4032 - Brisbane
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Austria
State/province [7] 0 0
Vienna
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
Canada
State/province [10] 0 0
Nova Scotia
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
China
State/province [13] 0 0
Hong Kong
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Prague
Country [15] 0 0
France
State/province [15] 0 0
Marseille
Country [16] 0 0
Germany
State/province [16] 0 0
Greifswald
Country [17] 0 0
Germany
State/province [17] 0 0
Hamburg
Country [18] 0 0
Germany
State/province [18] 0 0
Heidelberg
Country [19] 0 0
Germany
State/province [19] 0 0
Leipzig
Country [20] 0 0
Germany
State/province [20] 0 0
Regensburg
Country [21] 0 0
Italy
State/province [21] 0 0
Bologna
Country [22] 0 0
Netherlands
State/province [22] 0 0
Amsterdam
Country [23] 0 0
Netherlands
State/province [23] 0 0
Maastricht
Country [24] 0 0
Spain
State/province [24] 0 0
Barcelona
Country [25] 0 0
Spain
State/province [25] 0 0
Madrid
Country [26] 0 0
Switzerland
State/province [26] 0 0
Zurich
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Cambridge

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Actelion
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00091715
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00091715