A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension. - Full Text View

Purpose

A phase 3, randomized, double-blind, placebo-controlled study to assess safety and efficacy of ambrisentan in subjects with pulmonary arterial hypertension.

Condition	Intervention	Phase
Pulmonary Arterial Hypertension	Drug: ambrisentan	Phase III

Genetics Home Reference related topics:

pulmonary arterial hypertension

MedlinePlus related topics:

High Blood Pressure

Drug Information available for:

Ambrisentan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

Change from baseline in the six-minute walk distance evaluated after 12 weeks of therapy compared to placebo.

Secondary Outcome Measures:

Change from baseline measured after 12 weeks of treatment compared to placebo in the Borg Dyspnea Index immediately following exercise, WHO functional class and SF-36 Health Survey.
Clinical worsening of PAH.
Assessment of the safety and tolerability of the study drug.

Estimated Enrollment:	186
Study Start Date:	December 2003
Estimated Study Completion Date:	October 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years of age and older
Current diagnosis of either PPH or PAH secondary to the scleroderma spectrum of disease, systemic lupus erythematosus, anorexigen use, or HIV infection at the Screening Visit
Right heart catheterization, completed prior to Screening Visit must meet pre-specified hemodynamic criteria
Female subjects of childbearing potential must have a negative serum pregnancy test and must agree to use a reliable double barrier method of contraception until study completion and for at least four weeks following their final study visit
Male subjects must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking this study drug and queried regarding his understanding of the potential risks as described in the Informed Consent Form

Exclusion Criteria:

PAH due to or associated with congenital heart disease, coronary artery disease, left heart disease, interstitial lung disease, chronic obstructive pulmonary disease, veno-occlusive disease, chronic thrombotic and/or embolic disease, or sleep apnea
Portopulmonary hypertension
Bosentan within four weeks prior to Screening
Phosphodiesterase type V inhibitor or chronic prostanoid therapy within four weeks prior to Screening
IV inotrope use within two weeks prior to Screening
ALT or AST lab value that is greater than 1.5 times the upper limit of normal
Pulmonary function tests not meeting pre-specified criteria
Contraindication to treatment with an ERA
History of malignancies other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the past five years
Females who are pregnant or breastfeeding

Contacts and Locations

No Contacts or Locations Provided

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	AMB-321, ARIES-2
First Received:	January 17, 2007
Last Updated:	January 17, 2007
ClinicalTrials.gov Identifier:	NCT00423202
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Idiopathic pulmonary hypertension

Respiratory Tract Diseases

Hypertension, Pulmonary

Lung Diseases

Vascular Diseases

Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 22, 2008

Sponsored by:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00423202