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

NCT00864201 | Unknown Phase 3

• 1 other identifier: PAH-CTD-2007
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months

Secondary Outcomes (1)

• 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)

  6 months

Study Arms (1)

bosentan

EXPERIMENTAL

Drug: bosentan

Interventions

bosentan DRUG

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

bosentan

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Actelion: collaborator

Study Sites (1)

Victoria Medical Center

Hamilton, Ontario, L8L 5G4, Canada

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Connective Tissue Diseases

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Skin and Connective Tissue 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 Officials

• Christine Bradley

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Bradley, MD

CONTACT

905-546-9993; mkenney@bellnet.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 18, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: March 18, 2009

Record last verified: 2009-03

Locations

CA (1)