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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by McMaster University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Actelion
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00864201
First received: March 17, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hypertension, Pulmonary
Connective Tissue Disease
 Drug: bosentan
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Effect of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease

Resource links provided by NLM:

Drug Information available for: Bosentan
U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: April 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bosentan Drug: bosentan
bosentan 62mg bid x 4 weeks, followed by bosentan 125mg bid x 20 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00864201

Contacts
Contact: Christine Bradley, MD 905-546-9993 mkenney@bellnet.ca

Locations
Canada, Ontario
Victoria Medical Center Not yet recruiting
Hamilton, Ontario, Canada, L8L 5G4
Principal Investigator: Christine Bradley, MD            
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Actelion
Investigators
Principal Investigator: Christine Bradley Hamilton Health Sciences Corporation
  More Information

No publications provided

Responsible Party: Dr. Christine Bradley, Victoria Medical Centre
ClinicalTrials.gov Identifier: NCT00864201     History of Changes
Other Study ID Numbers: PAH-CTD-2007
Study First Received: March 17, 2009
Last Updated: March 17, 2009
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Hypertension, Pulmonary
Connective Tissue Diseases
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
 Cardiovascular Diseases
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013