Study of Ambrisentan in Participants With Pulmonary Hypertension

Phase 3

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Drug: Ambrisentan

• Registration Number: NCT00777920
• Lead Sponsor: Gilead Sciences

Brief Summary

The primary objective of this study is to monitor the long-term safety of ambrisentan in adult participants with pulmonary hypertension. The available ambrisentan doses for this study are 2.5, 5, or 10 mg administered orally once daily. Investigators will be able to adjust ambrisentan dose as clinically indicated. A minimum of 4 weeks between dose adjustments is required. Participants receiving other therapies for pulmonary hypertension that are not contraindicated for concomitant use with ambrisentan are permitted to enroll in this study and continue to receive such therapies. Participants enrolled in this study will receive treatment with ambrisentan until such time as the investigator or participant chooses to stop ambrisentan treatment, ambrisentan becomes commercially available, or the sponsor stops the study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-01
• Study First Submitted QC: 2008-10-21
• Study First Posted: 2008-10-22
• Study Start: 2008-11-17
• Primary Completion: 2019-09-11
• Study Completion: 2019-09-11
• Status Verified: 2020-09
• Results First Submitted: 2020-09-08
• Results First Submitted QC: 2020-09-08
• Last Update Submitted: 2020-09-08
• Results First Posted: 2020-09-30
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Men and women with pulmonary hypertension who are discontinuing a clinical study of ambrisentan due to study closure by the sponsor. Eligible participants are those participating in countries where ambrisentan is not yet commercially available. Participants participating in countries where ambrisentan is commercially available may be eligible if they do not qualify for treatment per the current prescribing information of that country.

Key

Exclusion Criteria

• Participants who have discontinued an ambrisentan clinical study for any other reason than sponsor-initiated study closure are not eligible.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ambrisentan	Ambrisentan	Participants will receive ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chooses to stop ambrisentan treatment, ambrisentan becomes commercially available, or the sponsor stops the study.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs) Associated With Long-Term Exposure to Ambrisentan	First dose date of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks)

Trial Locations

Locations (46)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Arizona Pulmonary Specialists; 🇺🇸 Phoenix, Arizona, United States

University of Colorado Health Science Center; 🇺🇸 Aurora, Colorado, United States

University of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States

Atlanta Institute for Medical Research, Inc.; 🇺🇸 Atlanta, Georgia, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

BACH Cardiology/Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Boston University Medical Center; 🇺🇸 Boston, Massachusetts, United States

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