CompletedPhase 3ACTRN12607000170426

Safety and Efficacy Study of Ambrisentan in Subjects with Pulmonary Hypertension

ARIES-3: A Phase 3, Long-term, Open-label, Multicenter Study of the Safety and Efficacy of Ambrisentan in Subjects with Pulmonary Hypertension

Sponsor

Gilead Sciences, Inc.

Enrollment

200 participants

Start Date

Aug 1, 2006

Study Type

Interventional

Conditions

Pulmonary Hypertension

Summary

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

Current diagnosis of PAH associated with an acceptable etiology as outlined in the protocol (i.e., idiopathic pulmonary arterial hypertension, familial pulmonary hypertension, PAH associated with interstitial lung disease, PAH due to chronic thromboembolic disease or sickle cell disease, PAH associated with chronic obstructive pulmonary disease, and associated PAH secondary to the scleroderma spectrum of disease, systemic lupus, erythematosus, anorexigen use, congenital heart defects, or human immunodeficiency virus (HIV) infection); 2) Receiving stable, chronic prostanoid treatment or oral phosphodiesterase type 5 (PDE-5) inhibitors for 4 weeks prior to the Screening Visit; 3) Receiving stable calcium channel blocker treatment or 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors for 4 weeks prior to the Screening Visit; 4) Right heart catheterization completed within 1 year prior to the Screening Visit and fulfilling all pre-specified criteria; 5) Pulmonary function tests fulfilling all pre-specified criteria; 6) Aminotransferase concentrations less than 1.5x the Upper Limit of Normal (ULN) at the Screening Visit; 7) Male and female subjects may be eligible for study participation; however, female subjects of childbearing potential must have a negative serum pregnancy test and must agree to use a reliable double method of contraception until study completion and for at least 4 weeks following their final study visit; 8) Male subjects must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking ambrisentan and queried regarding his understanding of the potential risks as described in the Informed Consent Form.

Exclusion Criteria1

Participation in a previous clinical study with ambrisentan;2) Treatment with bosentan or sitaxsentan within four weeks prior to the Screening Visit;3) Contraindication to treatment with endothelin receptor antagonists (ERAs);4) History of malignancies within 5 years prior to the Screening Visit, with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix;5) Female subject who is pregnant or breastfeeding.

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Interventions

This is a long-term, open-label study of a new experimental drug called ambrisentan. The purpose of this study is to evaluate the safety and efficacy of ambrisentan in a broad population of subjects with pulmonary arterial hypertension (PAH). Secondarily, this study will evaluate the effects of ambrisentan on other clinical measures of PAH, long-term treatment success, and survival. Subjects will receive 5 mg ambrisentan each day by mouth for the first 24 weeks. Then, subjects may receive 2.5, 5, or 10 mg each day by mouth, based on investigator discretion as clinically indicated. Each day of study participation subjects will receive ambrisentan until the study is ended or the subject discontinues study participation. Subjects may continue to receive ambrisentan until such time as the investigator or subject chooses to stop ambrisentan treatment, the cumulative adverse event profile does not warrant continuation of the study, ambrisentan becomes commercially available, or Gilead Sciences, Inc., stops the study.