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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR LETAIRIS

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Clinical Trials for Letairis

Trial ID Title Status Sponsor Phase Summary
NCT00380068 Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension Completed Gilead Sciences Phase 3 The primary objective of this study was to evaluate the safety and efficacy of ambrisentan in a broad population of participants with pulmonary hypertension (PH). Secondary objectives of this study were to evaluate the effects of ambrisentan on other clinical measures of pulmonary arterial hypertension (PAH), long-term treatment success, and survival.
NCT00617305 Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1) Completed Gilead Sciences Phase 4 To evaluate the change from baseline in pulmonary vascular resistance (PVR), and other hemodynamic parameters, following the addition of ambrisentan to background phosphodiesterase type-5 inhibitor (PDE-5i) therapy in subjects with pulmonary arterial hypertension (PAH) who have demonstrated a sub-optimal response to PDE-5i monotherapy. The study was originally designed as a 2-arm, double-blind, randomized study in which patients received ambrisentan or placebo for 24 weeks, and then received ambrisentan blinded to dose for 24 weeks. With Protocol Amendment 2 (12 June, 2009), the study was switched to single-arm, open-label treatment, and all patients remaining in the placebo arm were switched to open-label ambrisentan treatment. Patients who enrolled after Amendment 2 all received open-label ambrisentan.
NCT00725361 A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma). Completed Stanford University N/A This is a research study of an investigational drug called ambrisentan (Letairis) in the treatment and prevention of digital ulcers in patients with systemic sclerosis.
NCT00777920 Study of Ambrisentan in Subjects With Pulmonary Hypertension Active, not recruiting Gilead Sciences Phase 3 This Phase 3, international, multicenter, open-label study will monitor the long-term safety of ambrisentan in adults with pulmonary hypertension. The available ambrisentan doses for this study are 5 or 10 mg administered orally once daily; the approved doses of ambrisentan in the United States, Canada, and the European Union are 5 and 10 mg. 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.
NCT00840463 Safety and Efficacy Trial to Treat Diastolic Heart Failure Using Ambrisentan Terminated Gilead Sciences Phase 4 This is a randomized study of ambrisentan that will last 16 weeks. The study will include patients with diastolic heart failure and pulmonary hypertension. Patients will be randomized (1:1) to ambrisentan or placebo. The ambrisentan or matching placebo will be started at 2.5 mg by mouth daily and increased to 5mg and then 10mg daily, if tolerated. Patients will be seen at least monthly for 16 weeks. Adverse reactions will be reviewed and the required monthly laboratory tests (liver function testing and pregnancy testing, if applicable), will be performed. Patients will also complete an exercise test (six minute walk distance) and a quality of life survey at the baseline, week 4 and week 16 visit. An echocardiogram and a right heart catheterization and left ventricular end diastolic pressure measurement will be performed at the 16 week visit. The primary end-point is safety, and secondary end-points include the catheterization results, echocardiogram results, the walk distance and the quality of life survey. The expected completion of the study is 18 months from initiation. Ambrisentan is an FDA approved drug for PAH, but not for CHF.
NCT00840463 Safety and Efficacy Trial to Treat Diastolic Heart Failure Using Ambrisentan Terminated University of Texas Southwestern Medical Center Phase 4 This is a randomized study of ambrisentan that will last 16 weeks. The study will include patients with diastolic heart failure and pulmonary hypertension. Patients will be randomized (1:1) to ambrisentan or placebo. The ambrisentan or matching placebo will be started at 2.5 mg by mouth daily and increased to 5mg and then 10mg daily, if tolerated. Patients will be seen at least monthly for 16 weeks. Adverse reactions will be reviewed and the required monthly laboratory tests (liver function testing and pregnancy testing, if applicable), will be performed. Patients will also complete an exercise test (six minute walk distance) and a quality of life survey at the baseline, week 4 and week 16 visit. An echocardiogram and a right heart catheterization and left ventricular end diastolic pressure measurement will be performed at the 16 week visit. The primary end-point is safety, and secondary end-points include the catheterization results, echocardiogram results, the walk distance and the quality of life survey. The expected completion of the study is 18 months from initiation. Ambrisentan is an FDA approved drug for PAH, but not for CHF.
NCT00851929 Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension Unknown status Gilead Sciences Phase 2/Phase 3 Hypothesis: Ambrisentan (Letairis ®) is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Letairis

Condition Name

Condition Name for Letairis
Intervention Trials
Pulmonary Hypertension 7
Pulmonary Arterial Hypertension 6
Hypertension, Pulmonary 2
Portopulmonary Hypertension 2
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Condition MeSH

Condition MeSH for Letairis
Intervention Trials
Hypertension 17
Hypertension, Pulmonary 12
Familial Primary Pulmonary Hypertension 7
Scleroderma, Systemic 3
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Clinical Trial Locations for Letairis

Trials by Country

Trials by Country for Letairis
Location Trials
United States 112
Canada 9
Italy 8
Australia 7
Germany 7
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Trials by US State

Trials by US State for Letairis
Location Trials
Massachusetts 8
California 8
North Carolina 7
Ohio 6
New York 6
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Clinical Trial Progress for Letairis

Clinical Trial Phase

Clinical Trial Phase for Letairis
Clinical Trial Phase Trials
Phase 4 7
Phase 3 3
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Letairis
Clinical Trial Phase Trials
Completed 7
Recruiting 5
Active, not recruiting 3
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Clinical Trial Sponsors for Letairis

Sponsor Name

Sponsor Name for Letairis
Sponsor Trials
Gilead Sciences 11
National Heart, Lung, and Blood Institute (NHLBI) 2
Ochsner Health System 2
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Sponsor Type

Sponsor Type for Letairis
Sponsor Trials
Other 18
Industry 16
NIH 3
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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Daiichi Sankyo
Fish and Richardson
Federal Trade Commission
Deloitte
Baxter
AstraZeneca
Covington

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