DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: McMaster University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension, Pulmonary; Connective Tissue Disease

Intervention: bosentan (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Hamilton Health Sciences Corporation

Official(s) and/or principal investigator(s):
Christine Bradley, Principal Investigator, Affiliation: Hamilton Health Sciences Corporation

Overall contact:
Christine Bradley, MD, Phone: 905-546-9993, Email: mkenney@bellnet.ca

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.

Clinical Details

Official title: A Pilot Study to Evaluate the Effect of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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)

Secondary outcome: 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)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Christine Bradley, MD, Phone: 905-546-9993, Email: mkenney@bellnet.ca

Victoria Medical Center, Hamilton, Ontario L8L 5G4, Canada; Not yet recruiting
Christine Bradley, MD, Principal Investigator
Additional Information

Starting date: April 2009
Last updated: March 17, 2009

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017