Safety and Efficacy Study of Ambrisentan in Subjects with Pulmonary Hypertensio

Phase 3

Completed

• Conditions: Pulmonary Hypertension; Cardiovascular - Hypertension

• Registration Number: ACTRN12607000170426
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-14
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1) 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 Criteria

1) 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in the 6-minute walk distance (6MWD). The 6MWD is the longest possible distance that a subject can walk in a timed 6-minute interval.[ The 6MWD will be assessed at baseline, weeks 4, 12 and 24.]