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Last Updated: December 8, 2024

CLINICAL TRIALS PROFILE FOR ADCIRCA


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All Clinical Trials for Adcirca

Trial ID Title Status Sponsor Phase Start Date Summary
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 2008-04-01 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.
NCT01042158 ↗ A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis Completed Eli Lilly and Company Phase 4 2010-01-01 This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD). Standard outcome measures such as six-minute walk distance (6MWD), New York heart Association (NYHA) classification, and hemodynamic measurements will be assessed, as well as novel functional measures of RV-PV function including the transthoracic echocardiogram parameter tricuspid annular plane systolic ejection (TAPSE), contrast-enhanced cardiac MRI and heart rate variability assessed by Holter monitoring. This design (excluding a placebo arm) was selected for ethical concerns and to provide optimal efficiency and active therapy to all study subjects. It also allows for comparisons between the two monotherapies and with combination therapy.
NCT01042158 ↗ A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis Completed Johns Hopkins University Phase 4 2010-01-01 This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD). Standard outcome measures such as six-minute walk distance (6MWD), New York heart Association (NYHA) classification, and hemodynamic measurements will be assessed, as well as novel functional measures of RV-PV function including the transthoracic echocardiogram parameter tricuspid annular plane systolic ejection (TAPSE), contrast-enhanced cardiac MRI and heart rate variability assessed by Holter monitoring. This design (excluding a placebo arm) was selected for ethical concerns and to provide optimal efficiency and active therapy to all study subjects. It also allows for comparisons between the two monotherapies and with combination therapy.
NCT01042158 ↗ A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 4 2010-01-01 This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD). Standard outcome measures such as six-minute walk distance (6MWD), New York heart Association (NYHA) classification, and hemodynamic measurements will be assessed, as well as novel functional measures of RV-PV function including the transthoracic echocardiogram parameter tricuspid annular plane systolic ejection (TAPSE), contrast-enhanced cardiac MRI and heart rate variability assessed by Holter monitoring. This design (excluding a placebo arm) was selected for ethical concerns and to provide optimal efficiency and active therapy to all study subjects. It also allows for comparisons between the two monotherapies and with combination therapy.
NCT01042158 ↗ A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis Completed National Institutes of Health (NIH) Phase 4 2010-01-01 This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD). Standard outcome measures such as six-minute walk distance (6MWD), New York heart Association (NYHA) classification, and hemodynamic measurements will be assessed, as well as novel functional measures of RV-PV function including the transthoracic echocardiogram parameter tricuspid annular plane systolic ejection (TAPSE), contrast-enhanced cardiac MRI and heart rate variability assessed by Holter monitoring. This design (excluding a placebo arm) was selected for ethical concerns and to provide optimal efficiency and active therapy to all study subjects. It also allows for comparisons between the two monotherapies and with combination therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Adcirca

Condition Name

Condition Name for Adcirca
Intervention Trials
Pulmonary Arterial Hypertension 6
Healthy 4
Pulmonary Hypertension 4
Aortic Stenosis 2
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Condition MeSH

Condition MeSH for Adcirca
Intervention Trials
Hypertension 11
Pulmonary Arterial Hypertension 7
Familial Primary Pulmonary Hypertension 7
Hypertension, Pulmonary 7
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Clinical Trial Locations for Adcirca

Trials by Country

Trials by Country for Adcirca
Location Trials
United States 71
China 7
Japan 6
Germany 4
Brazil 4
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Trials by US State

Trials by US State for Adcirca
Location Trials
California 5
Missouri 4
Texas 4
New York 4
Massachusetts 4
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Clinical Trial Progress for Adcirca

Clinical Trial Phase

Clinical Trial Phase for Adcirca
Clinical Trial Phase Trials
Phase 4 8
Phase 3 3
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Adcirca
Clinical Trial Phase Trials
Completed 13
Terminated 4
Recruiting 3
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Clinical Trial Sponsors for Adcirca

Sponsor Name

Sponsor Name for Adcirca
Sponsor Trials
Eli Lilly and Company 4
United Therapeutics 3
Washington University School of Medicine 3
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Sponsor Type

Sponsor Type for Adcirca
Sponsor Trials
Other 26
Industry 16
NIH 4
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