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Last Updated: October 27, 2020

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CLINICAL TRIALS PROFILE FOR AMBRISENTAN

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505(b)(2) Clinical Trials for Ambrisentan

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT02688387 A Phase 1 Relative Bioavailability Study of Ambrisentan and Tadalfil Fixed Dose Combination Tablets in Healthy Subjects Recruiting Covance Harrogate Phase 1 2016-03-01 This study is designed to understand the relative bioavailability (proportion of the administered dose that is absorbed into the bloodstream) of several fixed dose combinations (FDCs) tablets of ambrisentan and tadalafil for further development and to provide pharmacokinetic (PK - what the body does to the drug) data to enable a pivotal bioequivalence (BE - the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability) study. Depending on formulation work, the study will allow up to 8 new FDCs to be compared with the reference of ambrisentan and tadalafil monotherapies. The study will also evaluate up to 2 of the new formulations, that may be taken in to a BE study, to be tested for any effect on pharmacokinetics of the FDC in both fed and fasted state. This is a single centre, Phase 1, single dose, randomised, open label crossover study with 3 study parts; each study part will have up to a 5 way crossover in healthy subjects. Part 1 of the study will evaluate four formulations of the FDC (ambrisentan 10 milligram [mg] + tadalafil 40 mg) and the reference of the 2 monotherapy components taken concurrently (ambrisentan 10 mg and tadalafil 40 mg) in the fasted stated. If successful formulations are identified in this part of the study, then they will be re-formulated and tested in part 2. If no successful formulations are identified in part 1 of the study, then part 2 will be utilized to look at up to 4 new FDC formulations. However, if only two formulations, or less, are evaluated in part 2 then the FDC formulations may be tested both fed and fasted to assess food effect and part 3 will not be required. If successful formulations are identified in this study part, then up to 2 of these may be tested, for food effect, in Part 3 if not already assessed in this part. Therefore, part 3 is optional and utility is dependent on the results of the previous study parts.
New Formulation NCT02688387 A Phase 1 Relative Bioavailability Study of Ambrisentan and Tadalfil Fixed Dose Combination Tablets in Healthy Subjects Recruiting Hammersmith Medicines Research Phase 1 2016-03-01 This study is designed to understand the relative bioavailability (proportion of the administered dose that is absorbed into the bloodstream) of several fixed dose combinations (FDCs) tablets of ambrisentan and tadalafil for further development and to provide pharmacokinetic (PK - what the body does to the drug) data to enable a pivotal bioequivalence (BE - the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability) study. Depending on formulation work, the study will allow up to 8 new FDCs to be compared with the reference of ambrisentan and tadalafil monotherapies. The study will also evaluate up to 2 of the new formulations, that may be taken in to a BE study, to be tested for any effect on pharmacokinetics of the FDC in both fed and fasted state. This is a single centre, Phase 1, single dose, randomised, open label crossover study with 3 study parts; each study part will have up to a 5 way crossover in healthy subjects. Part 1 of the study will evaluate four formulations of the FDC (ambrisentan 10 milligram [mg] + tadalafil 40 mg) and the reference of the 2 monotherapy components taken concurrently (ambrisentan 10 mg and tadalafil 40 mg) in the fasted stated. If successful formulations are identified in this part of the study, then they will be re-formulated and tested in part 2. If no successful formulations are identified in part 1 of the study, then part 2 will be utilized to look at up to 4 new FDC formulations. However, if only two formulations, or less, are evaluated in part 2 then the FDC formulations may be tested both fed and fasted to assess food effect and part 3 will not be required. If successful formulations are identified in this study part, then up to 2 of these may be tested, for food effect, in Part 3 if not already assessed in this part. Therefore, part 3 is optional and utility is dependent on the results of the previous study parts.
New Formulation NCT02688387 A Phase 1 Relative Bioavailability Study of Ambrisentan and Tadalfil Fixed Dose Combination Tablets in Healthy Subjects Recruiting GlaxoSmithKline Phase 1 2016-03-01 This study is designed to understand the relative bioavailability (proportion of the administered dose that is absorbed into the bloodstream) of several fixed dose combinations (FDCs) tablets of ambrisentan and tadalafil for further development and to provide pharmacokinetic (PK - what the body does to the drug) data to enable a pivotal bioequivalence (BE - the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability) study. Depending on formulation work, the study will allow up to 8 new FDCs to be compared with the reference of ambrisentan and tadalafil monotherapies. The study will also evaluate up to 2 of the new formulations, that may be taken in to a BE study, to be tested for any effect on pharmacokinetics of the FDC in both fed and fasted state. This is a single centre, Phase 1, single dose, randomised, open label crossover study with 3 study parts; each study part will have up to a 5 way crossover in healthy subjects. Part 1 of the study will evaluate four formulations of the FDC (ambrisentan 10 milligram [mg] + tadalafil 40 mg) and the reference of the 2 monotherapy components taken concurrently (ambrisentan 10 mg and tadalafil 40 mg) in the fasted stated. If successful formulations are identified in this part of the study, then they will be re-formulated and tested in part 2. If no successful formulations are identified in part 1 of the study, then part 2 will be utilized to look at up to 4 new FDC formulations. However, if only two formulations, or less, are evaluated in part 2 then the FDC formulations may be tested both fed and fasted to assess food effect and part 3 will not be required. If successful formulations are identified in this study part, then up to 2 of these may be tested, for food effect, in Part 3 if not already assessed in this part. Therefore, part 3 is optional and utility is dependent on the results of the previous study parts.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Ambrisentan

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00091598 ARIES - Ambrisentan in Patients With Moderate to Severe Pulmonary Arterial Hypertension (PAH) Completed Gilead Sciences Phase 3 2004-01-01 The primary objective is to determine the effect of ambrisentan on exercise capacity in subjects with PAH.
NCT00380068 Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension Completed Gilead Sciences Phase 3 2006-08-01 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.
NCT00423202 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension. Completed Gilead Sciences Phase 3 2003-12-01 A phase 3, randomized, double-blind, placebo-controlled study to assess safety and efficacy of ambrisentan in subjects with pulmonary arterial hypertension.
NCT00423592 Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial Hypertension Completed Gilead Sciences Phase 2 2005-05-01 This Phase 2 study was to determine the incidence of increased serum aminotransferase concentrations (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]), as well as the overall safety and tolerability of ambrisentan, in participants with pulmonary arterial hypertension (PAH), idiopathic PAH (IPAH), or familial PAH (FPAH) who had previously discontinued ERA therapy (bosentan or sitaxsentan) due to increased serum ALT or AST concentrations.
NCT00423748 Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension. Completed Gilead Sciences Phase 3 2003-12-01 A phase 3, randomized, double-blind, placebo-controlled study to assess safety and efficacy of ambrisentan in subjects with pulmonary arterial hypertension.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ambrisentan

Condition Name

Condition Name for Ambrisentan
Intervention Trials
Pulmonary Hypertension 15
Pulmonary Arterial Hypertension 15
Hypertension, Pulmonary 8
Systemic Sclerosis 4
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Condition MeSH

Condition MeSH for Ambrisentan
Intervention Trials
Hypertension 42
Hypertension, Pulmonary 28
Familial Primary Pulmonary Hypertension 25
Scleroderma, Systemic 6
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Clinical Trial Locations for Ambrisentan

Trials by Country

Trials by Country for Ambrisentan
Location Trials
United States 226
Germany 41
Canada 32
Australia 22
Italy 21
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Trials by US State

Trials by US State for Ambrisentan
Location Trials
Massachusetts 14
California 13
Texas 11
North Carolina 11
Pennsylvania 10
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Clinical Trial Progress for Ambrisentan

Clinical Trial Phase

Clinical Trial Phase for Ambrisentan
Clinical Trial Phase Trials
Phase 4 10
Phase 3 14
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Ambrisentan
Clinical Trial Phase Trials
Completed 25
Recruiting 10
Active, not recruiting 6
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Clinical Trial Sponsors for Ambrisentan

Sponsor Name

Sponsor Name for Ambrisentan
Sponsor Trials
Gilead Sciences 22
GlaxoSmithKline 12
Medical University of South Carolina 2
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Sponsor Type

Sponsor Type for Ambrisentan
Sponsor Trials
Other 75
Industry 42
NIH 4
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