Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.

Gilead Sciences

Status and phase

Completed

Phase 3

Conditions

Pulmonary Arterial Hypertension

Treatments

Drug: ambrisentan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00423748

AMB-320

ARIES-1

Details and patient eligibility

About

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

Full description

Subjects in these randomized studies will receive one of two doses of ambrisentan or placebo. Inclusion is not based on a specified WHO functional classification. Rather, subjects with WHO Class I-IV symptoms are eligible if their 6-minute walk distance is 150-450 meters and they meet the study-specified hemodynamic criteria. Subjects with anorexigen or HIV infection related PAH are eligible but subjects with congenital heart disease and pediatric subjects are excluded. The study requires a historical cardiac catheterization and other diagnostic procedures.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years of age or order
Current diagnosis of either PPH orPAH 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