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BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00367770
Recruitment Status : Completed
First Posted : August 23, 2006
Results First Posted : August 15, 2016
Last Update Posted : September 22, 2016
Sponsor:
Information provided by (Responsible Party):
Actelion

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pulmonary Arterial Hypertension
Intervention Drug: Tracleer®
Enrollment 37
Recruitment Details

Eight centers in six countries: Germany (1), Italy (2), the Netherlands (1), Spain (1), U.K. (2), U.S.A. (1)

Patients with stable PAH upon completion of the BREATHE-5 randomized, double-blind, placebocontrolled 16-week study were given option to enter into the open-label extension study.

Pre-assignment Details  
Arm/Group Title Tracleer
Hide Arm/Group Description The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.
Period Title: Overall Study
Started 37
Completed 35
Not Completed 2
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             1
Arm/Group Title Overall Study Arm
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants
39.8  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
25
  67.6%
Male
12
  32.4%
1.Primary Outcome
Title Change in 6-minute Walk Distance
Hide Description [Not Specified]
Time Frame from baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done in the safety set.
Arm/Group Title Overall Study Arm
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: m
13.5  (57.2)
2.Primary Outcome
Title Change in Borg Dyspnea Index
Hide Description Borg scale a numerical scale for assessing dyspnea, from 0 representing no dyspnea to 10 as maximal dyspnea.
Time Frame from baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done in the safety set.
Arm/Group Title Overall Study Arm
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.1  (1.4)
3.Primary Outcome
Title Number of Participants With a Change in WHO Functional Class
Hide Description

Number of participants with a change in WHO functional class from baseline to week 24.

A change from a higher to a lower functional class (i.e. III to II, III to I or II to I) is considered as an improvement.

Time Frame from baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done in the safety set.
Arm/Group Title Overall Study Arm
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
13
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tracleer
Hide Arm/Group Description The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.
All-Cause Mortality
Tracleer
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tracleer
Affected / at Risk (%)
Total   7/37 (18.92%) 
Cardiac disorders   
PALPITATIONS  1/37 (2.70%) 
Gastrointestinal disorders   
NAUSEA  1/37 (2.70%) 
rectal hemorrhage  1/37 (2.70%) 
General disorders   
sudden death  1/37 (2.70%) 
Infections and infestations   
GASTROENTERITIS VIRAL  1/37 (2.70%) 
Investigations   
ALANINE AMINOTRANSFERASE INCREASED  1/37 (2.70%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1/37 (2.70%) 
Nervous system disorders   
LETHARGY  1/37 (2.70%) 
Pregnancy, puerperium and perinatal conditions   
ABORTION SPONTANEOUS  2/37 (5.41%) 
pregnancy  1/37 (2.70%) 
1
Term from vocabulary, MedDRA Version 8
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tracleer
Affected / at Risk (%)
Total   25/37 (67.57%) 
Cardiac disorders   
PALPITATIONS  2/37 (5.41%) 
Gastrointestinal disorders   
DIARRHOEA  3/37 (8.11%) 
General disorders   
OEDEMA PERIPHERAL  7/37 (18.92%) 
CHEST PAIN  4/37 (10.81%) 
FATIGUE  2/37 (5.41%) 
Infections and infestations   
NASOPHARYNGITIS  5/37 (13.51%) 
LOWER RESPIRATORY TRACT INFECTION  2/37 (5.41%) 
VIRAL INFECTION  2/37 (5.41%) 
Investigations   
ALANINE AMINOTRANSFERASE INCREASED  2/37 (5.41%) 
ASPARTATE AMINOTRANSFERASE INCREASED  2/37 (5.41%) 
Metabolism and nutrition disorders   
GOUT  2/37 (5.41%) 
Nervous system disorders   
DIZZINESS  2/37 (5.41%) 
HEADACHE  2/37 (5.41%) 
Pregnancy, puerperium and perinatal conditions   
abortion spontaneous  2/37 (5.41%) 
Respiratory, thoracic and mediastinal disorders   
NASAL CONGESTION  2/37 (5.41%) 
1
Term from vocabulary, MedDRA Version 8
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Loïc Perchenet, Head of Global Post-Approval Studies
Organization: Actelion Pharmaceuticals Ltd.
Phone: +41 61 565 64 57
EMail: loic.perchenet@actelion.com
Layout table for additonal information
Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00367770     History of Changes
Other Study ID Numbers: AC-052-409
First Submitted: August 21, 2006
First Posted: August 23, 2006
Results First Submitted: April 11, 2016
Results First Posted: August 15, 2016
Last Update Posted: September 22, 2016