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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR PLETAL

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Clinical Trials for Pletal

Trial ID Title Status Sponsor Phase Summary
NCT00048763 Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud’s Phenomenon Completed Otsuka America Pharmaceutical Phase 4 Juvenile primary Raynaud’s (ray-knows) Phenomenon is a disorder of the blood vessels in the fingers and sometimes can affect the toes, nose, or ears. When children with primary Raynaud’s Phenomenon are exposed to chilly or cold conditions from weather, cold temperatures, or even holding cold items from the refrigerator, their fingers may become cold, numb, hurt, and/or turn purple or white. Children with primary Raynaud’s Phenomenon have no underlying systemic disease. The cause for their symptoms is unknown. The investigational drug, Pletal(cilostazol), which has been approved for other conditions, inhibits the ability of one type of blood cell, platelets, to form blood clots, and also widens narrowed blood vessels. It has been used in a variety of other conditions in which blood flow is decreased. This study will test the safety and effectiveness Pletal(cilostazol) to lessen the severity of the symptoms and decrease the number of primary Raynaud’s episodes in juvenile patients.
NCT00048776 Safety and Efficacy of Pletal (Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud’s Phenomenon Completed Otsuka America Pharmaceutical Phase 4 Juvenile secondary Raynaud’s (ray-knows) Phenomenon is a disorder of the blood vessels in the fingers and sometimes can affect the toes, nose, or ears. Children with secondary Raynaud’s Phenomenon have an underlying condition such as systemic lupus, scleroderma, or mixed connective tissue disease. When children with secondary Raynaud’s are exposed to chilly or cold conditions from weather, cold temperatures, or even holding cold items from the refrigerator, their fingers may become cold, numb, hurt, and/or turn purple or white. The investigational drug, Pletal(cilostazol), which has been approved for other conditions, inhibits the ability of one type of blood cell, platelets, to form blood clots, and also widens narrowed blood vessels. It has been used in a variety of other conditions in which blood flow is decreased. This study will test the safety and effectiveness Pletal(cilostazol) to lessen the severity of the symptoms and decrease the number of secondary Raynaud’s episodes in juvenile patients.
NCT00602173 Bioequivalency Study of 100 mg Cilostazol Tablets Under Fasting Conditions Completed Roxane Laboratories N/A The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol Tablets, 100 mg, to PLETAL® Tablets, 100 mg (OTSUKA Pharmaceuticals) under fasting conditions using a single-dose, randomized, 3-treatment, 3-period, crossover design.
NCT00602407 Bioequivalency Study of 50 mg Cilostazol Tablets Under Fasting Conditions Completed Roxane Laboratories N/A The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol Tablets, 50 mg, to PLETAL® Tablets, 50 mg (OTSUKA Pharmaceuticals) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, crossover design.
NCT00648388 Fasting Study of Cilostazol Tablets 100 mg and Pletal® Tablets 100 mg Completed Mylan Pharmaceuticals Phase 1 The objective of this study was to investigate the bioequivalence of Mylan's cilostazol 100 mg tablets and Otsuka's Pletal® 100 mg tablets following a single, oral 100 mg(1 x 100 mg) dose administered under fasting conditions.
NCT00684762 Fasted Bioavailability Study of Cilostazol Tablets, 100 mg Completed Mutual Pharmaceutical Company, Inc. Phase 1 The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under fasting conditions.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Pletal

Condition Name

Condition Name for Pletal
Intervention Trials
Intermittent Claudication 3
Healthy 2
Raynaud's Disease 2
Therapeutic Equivalency, Healthy 1
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Condition MeSH

Condition MeSH for Pletal
Intervention Trials
Intermittent Claudication 3
Raynaud Disease 2
Headache 1
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Clinical Trial Locations for Pletal

Trials by Country

Trials by Country for Pletal
Location Trials
United States 33
Denmark 1
Germany 1
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Trials by US State

Trials by US State for Pletal
Location Trials
Missouri 3
Pennsylvania 2
Massachusetts 2
Nebraska 2
New Jersey 2
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Clinical Trial Progress for Pletal

Clinical Trial Phase

Clinical Trial Phase for Pletal
Clinical Trial Phase Trials
Phase 4 2
Phase 1 6
N/A 3
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Clinical Trial Status

Clinical Trial Status for Pletal
Clinical Trial Phase Trials
Completed 10
Recruiting 1
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Clinical Trial Sponsors for Pletal

Sponsor Name

Sponsor Name for Pletal
Sponsor Trials
Otsuka America Pharmaceutical 2
Mutual Pharmaceutical Company, Inc. 2
Roxane Laboratories 2
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Sponsor Type

Sponsor Type for Pletal
Sponsor Trials
Industry 10
Other 1
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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Dow
Merck
Colorcon
Boehringer Ingelheim
US Army
Daiichi Sankyo
Covington
Cantor Fitzgerald

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