A Study to Evaluate the Use of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease

NCT ID: NCT00864201

Last Updated: 2009-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-04-30

Brief Summary

The primary objectives of this exploratory study are to evaluate the effects of bosentan on hemodynamics (via cardiac catheterization) during exercise in patients with Pulmonary Arterial Hypertension (PAH) who have abnormal hemodynamics during exercise but normal hemodynamics at rest. The authors hypothesize that early treatment may change the course of disease progression by improving hemodynamics during exercise, thus delaying disease progression.

Conditions

Hypertension, Pulmonary; Connective Tissue Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bosentan

Group Type: EXPERIMENTAL

bosentan

Intervention Type: DRUG

bosentan 62mg bid x 4 weeks, followed by bosentan 125mg bid x 20 weeks

Interventions

bosentan

bosentan 62mg bid x 4 weeks, followed by bosentan 125mg bid x 20 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men or women ≥ 18 years of age
• 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 contraceptives, if used in combination with a barrier method
• Body weight of 40 kg or higher
• Patients diagnosed with connective tissue disease
• Hemodynamics at rest, based on cardiac catheterization, should be as follows:

• Mean pulmonary arterial pressure (mPAP) : 18 - 25 mmHg
• PCWP ≤ 15 mmHg
• Hemodynamics during exercise, based on cardiac catheterization, should be as follows: mPAP > 30 mmHg
• Provide written informed consent

Exclusion Criteria

• PAH associated with any other condition
• Severe obstructive lung disease : FEV1∕ FVC <0.5
• Total lung capacity <60% of normal predicted value
• Unable or unwilling have a cardiac catheterization procedure
• Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements (6-MWT)
• Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements
• Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
• AST and ∕or ALT > 3 times uln
• Hemoglobin concentration > 25% below the lower limit of normal
• Systolic blood pressure < 85 mm Hg
• Pregnancy or breast-feeding
• Treatment or planned treatment with another investigational drug
• Treatment with an endothelin receptor antagonist, phosphodiesterase type 5 inhibitor, or with prostanoids (excluding acute administration during a catheterization procedure to test vascular reactivity) within 2 months of inclusion
• Treatment with calcineurin-inhibitors (i.e., cyclosporine A and tacrolimus), fluconazole, glibenclamide (glyburide) within 1 week of study start;
• Known hypersensitivity to bosentan or any of the excipients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actelion

INDUSTRY

Sponsor Role: collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Victoria Medical Centre

Principal Investigators

Christine Bradley

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Corporation

Locations

Victoria Medical Center

Hamilton, Ontario, Canada

Countries

Canada

Central Contacts

Christine Bradley, MD

Role: CONTACT

mkenney@bellnet.ca

905-546-9993

Other Identifiers

PAH-CTD-2007

Identifier Type: -

Identifier Source: org_study_id