Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00367770




Trial ID
NCT00367770
Ethics application status
Date submitted
21/08/2006
Date registered
22/08/2006
Date last updated
16/08/2016

Titles & IDs
Public title
BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
Scientific title
A Multi-Center, Open-Label Extension Study to Protocol AC-052-405 to Evaluate the Safety and Efficacy of Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
Secondary ID [1] 0 0
AC-052-409
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases

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

Experimental: Tracleer - 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.


Treatment: Drugs: Tracleer®
Patients will receive up to 125 mg b.i.d. of Tracleer.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in 6-minute Walk Distance
Timepoint [1] 0 0
from baseline to week 24
Primary outcome [2] 0 0
Change in Borg Dyspnea Index - Borg scale a numerical scale for assessing dyspnea, from 0 representing no dyspnea to 10 as maximal dyspnea.
Timepoint [2] 0 0
from baseline to week 24
Primary outcome [3] 0 0
Number of Participants With a Change in WHO Functional Class - 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.
Timepoint [3] 0 0
from baseline to week 24

Eligibility
Key inclusion criteria
1. Patients stable with PAH upon completion of the BREATHE-5 randomized, double-blind,
placebo- controlled 16-week study.

2. For female patients, only non-pregnant women who are surgically sterile,
postmenopausal or have documented infertility (over 50 years of age and amenorrheic
for at least 1 year), or those of childbearing potential using one of the following
methods of contraception: Barrier-type devices (e.g., condom, diaphragm) used ONLY in
combination with a spermicide. A double-barrier method is recommended; intrauterine
devices (IUDs); oral or implanted contraceptives, if used in combination with a
barrier method.

3. Patients providing written informed consent.
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who withdrew prematurely from BREATHE-5, AC-052-405.

2. Patients who are pregnant or nursing.

3. Patients who are receiving epoprostenol or prostacyclin analogues, or are expected to
receive any of these drugs during the study.

4. Patients with AST and/or ALT values greater than 3 times the upper limit of normal.

5. Patients with hemoglobin or hematocrit that is more than 30% below the normal range
(patients with secondary polycythemia are permitted in the study).

6. Patients with systolic blood pressure < 85 mm Hg.

7. Patients taking phosphodiesterase inhibitors, other endothelin receptor antagonists or
are receiving another investigational product.

8. Patients active on organ transplant list.

9. Patients who are receiving or expected to receive glyburide, cyclosporin A or
tacrolimus.

10. Patients not able to comply with the protocol or adhere to therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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?



Intervention assignment
Single group
Other design features
Phase
Phase 4
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Central Clinical School - Camperdown
Recruitment hospital [2] 0 0
The Royal Melbourne Hospital - Victoria
Recruitment postcode(s) [1] 0 0
NSW 2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3050 - Victoria
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
Canada
State/province [5] 0 0
Alberta
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
Germany
State/province [8] 0 0
Bad Oeynhausen
Country [9] 0 0
Germany
State/province [9] 0 0
Munchen
Country [10] 0 0
Italy
State/province [10] 0 0
Bologna
Country [11] 0 0
Italy
State/province [11] 0 0
Pavia
Country [12] 0 0
Netherlands
State/province [12] 0 0
Groningen
Country [13] 0 0
Spain
State/province [13] 0 0
Madrid
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Glasgow
Country [15] 0 0
United Kingdom
State/province [15] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
This 6-month open label study will evaluate the long term safety of bosentan (via oxygen
saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5
study (PAH related to Eisenmenger physiology). Treatment duration is 6 months.
Trial website
https://clinicaltrials.gov/show/NCT00367770
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Landzberg, MD
Address 0 0
BACH Pulmonary Hypertension Service, Boston, U.S.A.
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