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An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Patients With Exercise Induced Pulmonary Arterial Hypertension

Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Exercised Induced Pulmonary Arterial Hypertension

Intervention: ambrisentan (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Brigham and Women's Hospital

Official(s) and/or principal investigator(s):
Aaron Waxman, MD, PhD, Principal Investigator, Affiliation: Brigham and Women's Hospital

Overall contact:
Laurie Lawler, RN, Phone: 617-525-9731, Email: llawler@partners.org

Summary

The purpose of this study is asses whether ambrisentan can help people with Exercised Induced Pulmonary Arterial Hypertension. The investigators also want to find out if ambrisentan is safe to take without causing excessive side effects.

Clinical Details

Official title: An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Patients With Exercise Induced Pulmonary Arterial Hypertension

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The proportion of subjects who achieve categorical improvement will be assessed by a change from baseline in Advanced Level-3 Cardiopulmonary Exercise Test (CPET) to Week 24.

Secondary outcome: A change from baseline in 6-minute walk distance

Detailed description: Exercised Induce Pulmonary Arterial Hypertension (EIPAH) population: These patients may provide a unique window into the pathogenesis of PAH. Our data suggest that these patients may represent an early phase of PAH with an abnormal vascular response. The study includes an assessment of the potential impact of ambrisentan on exercise capacity Advanced Level-3 CPET, and New York Heart Association (NYHA) functional class.

Eligibility

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

Criteria:

Inclusion Criteria:

- The subject provides written informed consent before the commencement of any study

related procedure.

- The subject is 18 years of age or older.

- If a female subject of child-bearing potential, the subject must agree to use 2 forms

of contraceptive therapy, including at least 1 barrier method, throughout the study and follow-up. (Women who are surgically sterile or those post-menopausal for at least 2 years are not considered to be of childbearing potential.)

- The subject has findings of either exercise induced PAH on a Advanced Level -3 CPET

performed within the last 6-months and is a NYHA Class I or II.

- The subject has an LVEF 55%, obtained by any appropriate method (i. e., ECHO,

radionuclide imaging, or cardiac catheterization)

- The subject is taking a stable concomitant medication regimen for at least 4 weeks

prior to enrollment in the study that is not expected to change during the study period and follow-up. Changes in diuretic and/or nitrate therapy as needed during the study period are acceptable.

Locations and Contacts

Laurie Lawler, RN, Phone: 617-525-9731, Email: llawler@partners.org

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Laurie Lawler, RN, Phone: 617-525-9731, Email: llawler@partners.org
Aaron Waxman, MD, PhD, Principal Investigator
Additional Information

Starting date: September 2008
Last updated: July 23, 2014

Page last updated: August 23, 2015

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