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Last Updated: July 2, 2020

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CLINICAL TRIALS PROFILE FOR PRASUGREL HYDROCHLORIDE

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505(b)(2) Clinical Trials for Prasugrel Hydrochloride

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 Dosage NCT02435563 Dose Adaptation to Offset the Interaction Between Ticagrelor and Ritonavir by Population-based PK Modeling Active, not recruiting University Hospital, Geneva Phase 2 2014-08-01 Ticagrelor is a new generation antiplatelet agent with higher efficacy as compared to clopidogrel and prasugrel in treatment of patients with moderate and high ischemic risks. Ticagrelor is active as such and its hepatic metabolism by CYP3A generates also an active metabolite. Because of the remarkable progress in HIV therapies the number of older age patients is on the rise, requiring adequate cardiovascular treatment. Since frontline HIV therapies include ritonavir, a strong inhibitor of CYP3A enzyme, ticagrelor is contraindicated in these patients because of the expected interaction and bleeding risk. A lower efficacy of clopidogrel and prasugrel, which are both pro-drugs, in the presence of ritonavir has been already demonstrated. Therefore, administration of a lower dose of ticagrelor may be a good alternative in HIV patients in order to lessen the impact of this pharmacokinetic interaction. The aim of this study is to adjust the dose of ticagrelor in case of co-treatment with ritonavir to achieve the same pharmacokinetic profile as administered alone using a physiologically-based pharmacokinetic (PBPK) model. As the first step, a pharmacokinetic (PK) model for ticagrelor and its active metabolite will be created based on available in vitro and in vivo parameters in healthy volunteers. An open-label, 2 sessions cross over study will be conducted with 20 healthy male volunteers at Clinical Research Center (CRC) of Geneva University Hospitals (HUG). During the first session of the clinical trial, a single dose 180 mg ticagrelor will be administered to the volunteers and obtained pharmacokinetic data will be fitted into the model for optimization. Thereafter a simulated trial by the Simcyp® simulator in presence of a single dose 100 mg ritonavir will allow evaluating the impact of CYP3A inhibition on the concentration-time profile of ticagrelor and its active metabolite. The necessary dose of ticagrelor to minimize the magnitude of this interaction will be calculated. This new dose will be co-administered with ritonavir in the same volunteers during the second session of the clinical trial. The purpose is to obtain the same PK profile with single dose of 180 mg ticagrelor administered alone and with an adapted dose of ticagrelor co-administered with a single dose 100 mg ritonavir. Moreover, the pharmacodynamic effect of ticagrelor will be measured in both sessions of the clinical trial using two specific platelet function tests: the VAsodilator-Stimulated Phosphoprotein assay (VASP) and VerifyNow® P2Y12. With the same PK profile, the same pharmacodynamic activity is expected. The modulation of activity of CYP3A and P-gp by ritonavir will be also monitored using micro dose midazolam and fexofenadine as probe substrates. The purpose of this study is to use the Simcyp® Simulator mechanistic PBPK modeling to broaden the application field of ticagrelor, especially in HIV patients. Since PK models are often created after clinical observations, the prospective aspect of this study is of particular value as the model will be first created and then applied to an unknown clinical scenario.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Prasugrel Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00059215 A Trial of CS-747 (Prasugrel) Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention (PCI) Completed Eli Lilly and Company Phase 2 2003-04-01 The purpose of this study is to evaluate the effects of a drug known as CS-747 (also known as prasugrel) on subjects having a procedure called a percutaneous coronary intervention (also referred to as PCI) in which a doctor will attempt to open a blocked vessel (or vessels) in the heart using a catheter (a long thin tube) that has a small balloon on the end. In many cases, patients who have this procedure receive a stent, a small wire spring that helps keep the vessel open.
NCT00097591 A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention Completed Daiichi Sankyo Inc. Phase 3 2004-11-01 The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.
NCT00097591 A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention Completed Eli Lilly and Company Phase 3 2004-11-01 The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.
NCT00356135 Effect of Prasugrel on Platelets After One Week in Patients Already Taking Clopidogrel After a Cardiac Event Completed Daiichi Sankyo Inc. Phase 2 2006-07-01 This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous coronary intervention (PCI) with placement of a stent, performed to treat acute coronary syndrome (ACS).
NCT00356135 Effect of Prasugrel on Platelets After One Week in Patients Already Taking Clopidogrel After a Cardiac Event Completed Eli Lilly and Company Phase 2 2006-07-01 This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous coronary intervention (PCI) with placement of a stent, performed to treat acute coronary syndrome (ACS).
NCT00357968 Trial in Subjects Undergoing Cardiac Catheterization With Planned Percutaneous Coronary Intervention With Stenting Completed Daiichi Sankyo Inc. Phase 2 2006-08-01 The purpose of this study is to provide information of the relative potency of prasugrel and clopidogrel on platelet function studies, inflammation, and myocyte necrosis in subjects undergoing elective percutaneous coronary intervention (PCI).
NCT00357968 Trial in Subjects Undergoing Cardiac Catheterization With Planned Percutaneous Coronary Intervention With Stenting Completed The TIMI Study Group Phase 2 2006-08-01 The purpose of this study is to provide information of the relative potency of prasugrel and clopidogrel on platelet function studies, inflammation, and myocyte necrosis in subjects undergoing elective percutaneous coronary intervention (PCI).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Prasugrel Hydrochloride

Condition Name

Condition Name for Prasugrel Hydrochloride
Intervention Trials
Coronary Artery Disease 51
Acute Coronary Syndrome 38
Myocardial Infarction 15
Cardiovascular Diseases 6
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Condition MeSH

Condition MeSH for Prasugrel Hydrochloride
Intervention Trials
Coronary Artery Disease 61
Myocardial Ischemia 59
Coronary Disease 56
Acute Coronary Syndrome 54
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Clinical Trial Locations for Prasugrel Hydrochloride

Trials by Country

Trials by Country for Prasugrel Hydrochloride
Location Trials
United States 394
United Kingdom 37
Italy 29
Germany 24
Canada 23
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Trials by US State

Trials by US State for Prasugrel Hydrochloride
Location Trials
Florida 32
Texas 16
Massachusetts 16
Ohio 15
California 14
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Clinical Trial Progress for Prasugrel Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Prasugrel Hydrochloride
Clinical Trial Phase Trials
Phase 4 95
Phase 3 41
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Prasugrel Hydrochloride
Clinical Trial Phase Trials
Completed 88
Recruiting 36
Not yet recruiting 23
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Clinical Trial Sponsors for Prasugrel Hydrochloride

Sponsor Name

Sponsor Name for Prasugrel Hydrochloride
Sponsor Trials
Eli Lilly and Company 26
Daiichi Sankyo Inc. 18
University of Patras 13
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Sponsor Type

Sponsor Type for Prasugrel Hydrochloride
Sponsor Trials
Other 218
Industry 96
U.S. Fed 2
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