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

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367770
• Other study ID #: AC-052-409
• Status: Completed
• Phase: Phase 4
• First received: August 21, 2006
• Last updated: February 11, 2010
• Start date: January 2004
• Est. completion date: December 2005

Study information

• Verified date: November 2006
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 amenrrheic 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.

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eisenmenger Complex
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Tracleer® (bosentan)

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital - Central Clinical School	Camperdown
Australia	The Royal Melbourne Hospital	Victoria
Austria	Universitatsklinikum fur Innere Medizin II	Wien
Belgium	UZ Gasthuisberg	Leuven
Canada	The Peter Lougheed Centre	Calgary	Alberta
Canada	Toronto General Hospital	Toronto	Ontario
France	Hospital Necker-Enfants Malades	Paris
Germany	Herzzentrum NRW	Bad Oeynhausen
Germany	Deutsches Herzzentrum Munchen	Munchen
Italy	University of Bologna	Bologna
Italy	San Matteo Hospital	Pavia
Netherlands	Academisch Ziekenhuis Groningen	Groningen
Spain	Unidad Medico Quirurgica de Cardiologia - Edificio General	Madrid
United Kingdom	Scottish Vascular Unit - Western Infirmary	Glasgow
United Kingdom	Royal Brompton Hospital	London
United States	BACH Pulmonary Hypertension Service	Boston	Massachusetts
United States	Texas Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious adverse events
Primary	Adverse events leading to dose reduction, temporary interruption or permanent discontinuation
Primary	Laboratory tests and oxygen saturation
Secondary	Six minute walk test at week 24
Secondary	Borg dyspnea index at week 24