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

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Tracleer®
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring bosentan, PAH related to Eisenmenger physiology, Tracleer

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients stable with PAH upon completion of the BREATHE-5 randomized, double-blind, placebo- controlled 16-week study. 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. Patients providing written informed consent. Exclusion Criteria: Patients who withdrew prematurely from BREATHE-5, AC-052-405. Patients who are pregnant or nursing. Patients who are receiving epoprostenol or prostacyclin analogues, or are expected to receive any of these drugs during the study. Patients with AST and/or ALT values greater than 3 times the upper limit of normal. Patients with hemoglobin or hematocrit that is more than 30% below the normal range (patients with secondary polycythemia are permitted in the study). Patients with systolic blood pressure < 85 mm Hg. Patients taking phosphodiesterase inhibitors, other endothelin receptor antagonists or are receiving another investigational product. Patients active on organ transplant list. Patients who are receiving or expected to receive glyburide, cyclosporin A or tacrolimus. Patients not able to comply with the protocol or adhere to therapy.

Sites / Locations

  • BACH Pulmonary Hypertension Service
  • Texas Children's Hospital
  • Royal Prince Alfred Hospital - Central Clinical School
  • The Royal Melbourne Hospital
  • Universitatsklinikum fur Innere Medizin II
  • UZ Gasthuisberg
  • The Peter Lougheed Centre
  • Toronto General Hospital
  • Hospital Necker-Enfants Malades
  • Herzzentrum NRW
  • Deutsches Herzzentrum Munchen
  • University of Bologna
  • San Matteo Hospital
  • Academisch Ziekenhuis Groningen
  • Unidad Medico Quirurgica de Cardiologia - Edificio General
  • Scottish Vascular Unit - Western Infirmary
  • Royal Brompton Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tracleer

Arm 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.

Outcomes

Primary Outcome Measures

Change in 6-minute Walk Distance
Change in Borg Dyspnea Index
Borg scale a numerical scale for assessing dyspnea, from 0 representing no dyspnea to 10 as maximal dyspnea.
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.

Secondary Outcome Measures

Full Information

First Posted
August 21, 2006
Last Updated
August 16, 2016
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT00367770
Brief Title
BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a multicenter, open-label, single -arm study with bosentan, initial dose of 62.5 mg b.i.d., with a target dose of 125 mg b.i.d. All patients will be assessed for eligibility during the baseline visit (same as Week 16, end of study BREATHE-5 visit), and will have the option to enter into the open-label extension study at a starting dose of 62.5 mg b.i.d., for safety reasons. Visit 2 is required as a safety visit to assess oxygen saturation (SpO2) after 1 week of bosentan treatment. Patients will return for Visit 4 after 4 weeks of treatment, and the dose will be up-titrated to 125 mg b.i.d. or maintained at 62.5 mg b.i.d. at the judgement of the investigator. Data will be collected for a total of 24 weeks or until the sponsor decides to stop the study. If the results from Study AC-052-403 or AC-052-405 demonstrate significant safety issues, this extension study may be terminated at the sponsor's request.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
bosentan, PAH related to Eisenmenger physiology, Tracleer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tracleer
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Tracleer®
Intervention Description
Patients will receive up to 125 mg b.i.d. of Tracleer.
Primary Outcome Measure Information:
Title
Change in 6-minute Walk Distance
Time Frame
from baseline to week 24
Title
Change in Borg Dyspnea Index
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
Title
Number of Participants With a Change in WHO Functional Class
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients stable with PAH upon completion of the BREATHE-5 randomized, double-blind, placebo- controlled 16-week study. 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. Patients providing written informed consent. Exclusion Criteria: Patients who withdrew prematurely from BREATHE-5, AC-052-405. Patients who are pregnant or nursing. Patients who are receiving epoprostenol or prostacyclin analogues, or are expected to receive any of these drugs during the study. Patients with AST and/or ALT values greater than 3 times the upper limit of normal. Patients with hemoglobin or hematocrit that is more than 30% below the normal range (patients with secondary polycythemia are permitted in the study). Patients with systolic blood pressure < 85 mm Hg. Patients taking phosphodiesterase inhibitors, other endothelin receptor antagonists or are receiving another investigational product. Patients active on organ transplant list. Patients who are receiving or expected to receive glyburide, cyclosporin A or tacrolimus. Patients not able to comply with the protocol or adhere to therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Landzberg, MD
Organizational Affiliation
BACH Pulmonary Hypertension Service, Boston, U.S.A.
Official's Role
Study Chair
Facility Information:
Facility Name
BACH Pulmonary Hypertension Service
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2303
Country
United States
Facility Name
Royal Prince Alfred Hospital - Central Clinical School
City
Camperdown
ZIP/Postal Code
NSW 2050
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Universitatsklinikum fur Innere Medizin II
City
Wien
ZIP/Postal Code
AT-1090
Country
Austria
Facility Name
UZ Gasthuisberg
City
Leuven
ZIP/Postal Code
BE-3000
Country
Belgium
Facility Name
The Peter Lougheed Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Hospital Necker-Enfants Malades
City
Paris
ZIP/Postal Code
75007
Country
France
Facility Name
Herzzentrum NRW
City
Bad Oeynhausen
ZIP/Postal Code
D-32545
Country
Germany
Facility Name
Deutsches Herzzentrum Munchen
City
Munchen
ZIP/Postal Code
D-80636
Country
Germany
Facility Name
University of Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
San Matteo Hospital
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Academisch Ziekenhuis Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Unidad Medico Quirurgica de Cardiologia - Edificio General
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Scottish Vascular Unit - Western Infirmary
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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