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

• Sponsor: Gilead Sciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00423202
• Collaborator: (none)
• Enrollment: 186
• Duration (Months): 22

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension	Drug: ambrisentan	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.
• Study Start Date: Dec 1, 2003
• Study Completion Date: Oct 1, 2005

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. 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. []

2. Clinical worsening of PAH. []

3. Assessment of the safety and tolerability of the study drug. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Gilead Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00423202
• Other Study ID Numbers: AMB-321; ARIES-2
• First Posted: Jan 18, 2007
• Last Update Posted: Apr 16, 2009
• Last Verified: Apr 1, 2009

• Additional relevant MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension; Ambrisentan

Study Results

No Results Posted as of Apr 16, 2009