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Pharmacodynamic Study of Cilostazol in Healthy Volunteers (CiloMecT)

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ClinicalTrials.gov Identifier: NCT02554721
Recruitment Status : Active, not recruiting
First Posted : September 18, 2015
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
The primary objective of this study is to investigate the effects of Cilostazol, Acetylsalycylic acid and Clopidogrel alone as well as combinations of Cilostazol/Acetylsalicylic acid and Cilostazol/ Clopidogrel on ex-vivo Platelet Function (PF) testing.

Condition or disease Intervention/treatment Phase
Healthy Drug: Cilostazol Drug: Acetylsalicylic acid Drug: Clopidogrel Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Cilostazol as an add-on Treatment to a Single Antiplatelet Agent (Acetylsalicylic Acid or Clopidogrel) on Platelet Function Testing and Bleeding Time in Healthy Volunteers
Actual Study Start Date : August 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 (CYP2C19 Wild Type)
Trial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Acetylsalicylic acid 100 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Acetylsalicylic acid 100mg once daily for 1 week (Days 22-28)
Drug: Cilostazol
Drug: Acetylsalicylic acid
Experimental: Group 2 (CYP2C19 Wild Type)
Trial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Clopidogrel 75 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Clopidogrel 75 mg once daily for 1 week (Days 22-28)
Drug: Cilostazol
Drug: Clopidogrel
Experimental: Group 3 (CYP2C19 heterozygous (*1/*2) )
Trial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Clopidogrel 75 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Clopidogrel 75 mg once daily for 1 week (Days 22-28)
Drug: Cilostazol
Drug: Clopidogrel
Experimental: Group 4 (CYP2C19 homozygous (*2/*2))
Trial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Clopidogrel 75 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Clopidogrel 75 mg once daily for 1 week (Days 22-28)
Drug: Cilostazol
Drug: Clopidogrel



Primary Outcome Measures :
  1. Change in ex-vivo inhibition of platelet aggregation from baseline [ Time Frame: Day 14(Baseline), Day 22, and Day 29 ]

Secondary Outcome Measures :
  1. Change skin bleeding time from baseline [ Time Frame: Day 14(Baseline), Day 22, and Day 29 ]
  2. Change safety from baseline [ Time Frame: Baseline(Day0), Day7, Day 14, Day 21, and Day 28 ]
    Vital signs, Physical examination, ECG, Safety lab, Adverse events



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Caucasian male subjects
  • Able to read, to write and to fully understand German language
  • Provision of written informed consent before screening and baseline
  • BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive
  • Good general health as determined by the investigator by medical history, physical examination, vital signs, electrocardiogram, baseline and safety lab

Exclusion Criteria:

  • Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms
  • Known predisposition to bleeding (e.g. active peptic ulceration, recent (within 6 month) haemorrhagic stroke, proliferative diabetic retinopathy, poorly controlled hypertension)
  • Use of antibiotics within thirty (30) days prior to screening and until baseline visit
  • Clinically significant abnormalities in medical history, physical examination, vital signs, electrocardiogram, baseline and safety lab
  • Supine pulse rate > 100 beats/min or <50 beats/min
  • Systolic blood pressure <100 or >140 mmHg
  • Diastolic blood pressure <50 or >90 mmHg
  • Concomitant use of any other medication including over-the-counter preparations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554721


Locations
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Germany
Bad Krozingen, Germany
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Osamu Sato Otsuka Pharmaceutical Co., Ltd.

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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02554721     History of Changes
Other Study ID Numbers: 21-13-102
2013-002633-38 ( EudraCT Number )
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Healthy Volunteers
Additional relevant MeSH terms:
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Aspirin
Platelet Aggregation Inhibitors
Cilostazol
Clopidogrel
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasodilator Agents
Neuroprotective Agents
Protective Agents