- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00864201
A Study to Evaluate the Use of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease
March 17, 2009 updated by: Hamilton Health Sciences Corporation
A Pilot Study to Evaluate the Effect of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christine Bradley, MD
- Phone Number: 905-546-9993
- Email: mkenney@bellnet.ca
Study Locations
-
-
Ontario
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Hamilton, Ontario, Canada, L8L 5G4
- Victoria Medical Center
-
Principal Investigator:
- Christine Bradley, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: bosentan
|
bosentan 62mg bid x 4 weeks, followed by bosentan 125mg bid x 20 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary outcome is the change in the following hemodynamics during exercise: pulmonary vascular resistance (PVR), mean pulmonary arterial pressure (mPAP), cardiac output∕cardiac input (CO∕CI), mean right arterial pressure (mRAP)
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in hemodynamics at rest: pulmonary vascular resistance (PVR), mean pulmonary arterial pressure (mPAP), cardiac output/cardiac input (CO∕CI), mean right arterial pressure (mRAP)
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Christine Bradley, Hamilton Health Sciences Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Anticipated)
April 1, 2010
Study Completion (Anticipated)
April 1, 2010
Study Registration Dates
First Submitted
March 17, 2009
First Submitted That Met QC Criteria
March 17, 2009
First Posted (Estimate)
March 18, 2009
Study Record Updates
Last Update Posted (Estimate)
March 18, 2009
Last Update Submitted That Met QC Criteria
March 17, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAH-CTD-2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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