Overview

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

Status:
Completed
Trial end date:
2005-10-01
Target enrollment:
0
Participant gender:
All
Summary
A phase 3, randomized, double-blind, placebo-controlled study to assess safety and efficacy of ambrisentan in subjects with pulmonary arterial hypertension.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Treatments:
Ambrisentan
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