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

Summary

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests the safety and effectiveness of ambrisentan, a medication for pulmonary arterial hypertension (high blood pressure in the lungs). This study is open to both men and women aged 18 and older. Participation involves taking the study drug daily and attending regular clinic visits for heart and lung monitoring.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 w

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.


Locations(1)

United States of America

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