Phase 1
N=77
Pharmacodynamic Study of Cilostazol in Healthy Volunteers
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02554721 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Ex-vivo Inhibition Of Platelet Aggregation (IPA) — 0.82; 1.21; 1.03; 4.42 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Cilostazol (Drug); Acetylsalicylic acid (Drug); Clopidogrel (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ex-vivo Inhibition Of Platelet Aggregation (IPA) |
0.82; 1.21; 1.03; 4.42 | — |
| SECONDARY Effects On Skin Bleeding Time (BT) |
1.31; 1.27 | — |
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.
Eligibility 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 140 mmHg
- Diastolic blood pressure 90 mmHg
- Concomitant use of any other medication including over-the-counter preparations
Data sourced from ClinicalTrials.gov (NCT02554721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.