Effects of Tracleer (Bosentan) on Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

NCT00317486 | Completed Phase 4

• 1 other identifier: AC-052-405
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the effects of bosentan on oxygen saturation, hemodynamics and exercise capacity in patients with pulmonary arterial hypertension related to Eisenmenger physiology. Patients receive bosentan or placebo for 16 weeks.

Conditions

Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

Keywords

pulmonary arterial hypertension; Eisenmenger physiology; bosentan

Outcome Measures

Primary Outcomes (2)

• Change from baseline to Week 16 in oxygen saturation at rest with room air

• Change from baseline to Week 16 in indexed pulmonary vascular resistance

Secondary Outcomes (1)

• Changes from baseline to Week 16 in cardiac hemodynamics

Interventions

bosentan DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients at least 12 years with a body weight at least 40 kg (inclusive) and with a functional class III (1998 WHO classification).
• Patients with pulmonary arterial hypertension related to Eisenmenger physiology echocardiographically established as atrial septal defect at least 2 cm effective diameter and/or ventricular septal defect at least 1 cm effective diameter; PAH confirmed via cardiac catheterization: mean pulmonary arterial pressure \>25 mm Hg, pulmonary capillary wedge pressure \<15 mm Hg and pulmonary vascular resistance \>3 mm Hg/l/min.
• Patients with documented oxygen saturation up to 90%, and \>70% (at rest, with room air).
• Patients able to perform a 6-minute walk test at least 150 m, and up to 450 m.
• Patients stable for at least 3 months prior to screening.
• Bosentan naïve patients.
• Female patients who are surgically sterile, postmenopausal or have documented infertility.
• Female patients 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.

You may not qualify if:

• Pregnant patients, nursing mothers.
• Patients with left ventricular dysfunction (ejection fraction \<40%).
• Patients with restrictive lung disease (TLC\<70% predicted); obstructive lung disease (FEV1\<70% predicted, with FEV1/FVC\<60%)
• Patients with systolic blood pressure \< 85 mm Hg.
• Patients with other conditions that may affect the ability to perform a 6-minute walk test.
• Patients unable to provide informed consent and comply with the patient protocol.
• Patients with known coronary arterial disease.
• Patients with serum creatinine \>125 µM/l.
• Patients with iron deficiency (serum ferritin \<10 ng/ml) unless corrected by iron supplement.
• Patients with hemoglobin or hematocrit that is more than 30% below the normal range (patients with secondary polycythemia are permitted).
• Patients with AST and/or ALT values greater than 3 times the upper limit of normal.
• Patients who have started or stopped treatment for PAH within one month of screening, excluding anticoagulation.
• Patients who are receiving vasodilators including, but not limited to epoprostenol or prostacyclin analogues, or are expected to receive any of these drugs during the study.
• Patients active on organ transplant lists.
• Patients taking phosphodiesterase inhibitors or endothelin receptor antagonists (other than bosentan) or any other investigational drugs/devices.

Sponsors & Collaborators

• Actelion: lead

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 21, 2006
• First Posted: April 25, 2006
• Study Start: September 1, 2003
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: February 4, 2025

Record last verified: 2025-01