Trial · NCT02554721
Pharmacodynamic Study of Cilostazol in Healthy Volunteers
NCT02554721, Phase 1, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2021-10-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacodynamic Study of Cilostazol in Healthy Volunteers. Trials, record NCT02554721. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02554721
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacodynamic Study of Cilostazol in Healthy Volunteers
- NCT number
- NCT02554721
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 77 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Healthy
- Interventions
- Cilostazol, Acetylsalicylic acid, Clopidogrel
- First posted
- 2015-09-18
- Last updated
- 2021-10-13
- Other registries' IDs
- eudract:2013-002633-38
- Results first posted
- 2021-10-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ex-vivo Inhibition Of Platelet Aggregation (IPA) | Baseline, Visit 5 (Day 22-29) | The effect of ASA in combination with cilostazol and clopidogrel in combination with cilostazol on IPA was determined ex vivo in citrated platelet rich plasma (PRP) after stimulation of aggregation by low-level adenosine diphosphate (ADP) (5 micromolar \[uM\]) and arachidonic acid (AA) (500 milligrams/liter \[mg/L\]). Light transmission aggregometry (LTA) was used to measure residual aggregation (the percentage of aggregation 5 minutes after the addition of ADP or AA). Results are reported as the 95% confidence intervals for the reported geometric mean ratios (GMRs) (\[cilostazol+reference (ASA or clopidogrel)\]/reference) for IPA. |
| Secondary | Effects On Skin Bleeding Time (BT) | Visit 5 (Day 22-29) | The effect of ASA in combination with cilostazol and clopidogrel in combination with cilostazol on skin BT (minutes) was determined with the Ivy method, utilizing standardized bleeding with the Surgicutt device. Results include the 95% confidence intervals for the reported GMRs (\[cilostazol+reference\]/reference) for skin BT. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ex-vivo Inhibition Of Platelet Aggregation (IPA) | Baseline, Visit 5 (Day 22-29) | Full Analysis Set: All subjects who completed both periods of treatment with reference medication alone (Period C) and treatment with reference medication and cilostazol (Period D) | ratio | GEOMETRIC_MEAN |
| SECONDARY | Effects On Skin Bleeding Time (BT) | Visit 5 (Day 22-29) | Full Analysis Set: All subjects who completed both periods of treatment with reference medication alone (Period C) and treatment with reference medication and cilostazol (Period D) | ratio | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ex-vivo Inhibition Of Platelet Aggregation (IPA) | Acetylsalicylic Acid - Cilostazol | 5 µM ADP | 0.82 | 95% Confidence Interval 0.5 to 1.37 | ratio |
| Ex-vivo Inhibition Of Platelet Aggregation (IPA) | Clopidogrel - Cilostazol | 5 µM ADP | 1.21 | 95% Confidence Interval 1.09 to 1.35 | ratio |
| Ex-vivo Inhibition Of Platelet Aggregation (IPA) | Acetylsalicylic Acid - Cilostazol | 500 mg/L AA | 1.03 | 95% Confidence Interval 1.01 to 1.05 | ratio |
| Ex-vivo Inhibition Of Platelet Aggregation (IPA) | Clopidogrel - Cilostazol | 500 mg/L AA | 4.42 | 95% Confidence Interval 3.42 to 5.73 | ratio |
| Effects On Skin Bleeding Time (BT) | Acetylsalicylic Acid - Cilostazol | 1.31 | 95% Confidence Interval 1.05 to 1.63 | ratio | |
| Effects On Skin Bleeding Time (BT) | Clopidogrel - Cilostazol | 1.27 | 95% Confidence Interval 1.09 to 1.48 | ratio |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 (CYP2C19 EM) | 20 | |
| Overall Study | STARTED | Group 2 (CYP2C19 EM) | 19 | |
| Overall Study | STARTED | Group 3 (CYP2C19 IM) | 19 | |
| Overall Study | STARTED | Group 4 CYP2C19 PM) | 17 | |
| Overall Study | STARTED | Not Assigned | 2 | |
| Overall Study | COMPLETED | Group 1 (CYP2C19 EM) | 19 | |
| Overall Study | COMPLETED | Group 2 (CYP2C19 EM) | 19 | |
| Overall Study | COMPLETED | Group 3 (CYP2C19 IM) | 19 | |
| Overall Study | COMPLETED | Group 4 CYP2C19 PM) | 17 | |
| Overall Study | COMPLETED | Not Assigned | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | Cilostazol | 5 | 77 | |
| other | Palpitations | Cardiac disorders | Acetylsalicylic Acid | 0 | 20 | |
| other | Palpitations | Cardiac disorders | Clopidogrel | 0 | 55 | |
| other | Palpitations | Cardiac disorders | Acetylsalicylic Acid - Cilostazol | 2 | 20 | |
| other | Palpitations | Cardiac disorders | Clopidogrel - Cilostazol | 3 | 55 | |
| other | Headache | Nervous system disorders | Cilostazol | 60 | 77 | |
| other | Headache | Nervous system disorders | Acetylsalicylic Acid | 1 | 20 | |
| other | Headache | Nervous system disorders | Clopidogrel | 2 | 55 | |
| other | Headache | Nervous system disorders | Acetylsalicylic Acid - Cilostazol | 10 | 20 | |
| other | Headache | Nervous system disorders | Clopidogrel - Cilostazol | 38 | 55 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cilostazol | 0 | 77 |
| Total, all-cause mortality | Acetylsalicylic Acid | 0 | 20 |
| Total, all-cause mortality | Clopidogrel | 0 | 55 |
| Total, all-cause mortality | Acetylsalicylic Acid - Cilostazol | 0 | 20 |
| Total, all-cause mortality | Clopidogrel - Cilostazol | 0 | 55 |
| Total, other adverse events | Cilostazol | 62 | 77 |
| Total, other adverse events | Acetylsalicylic Acid | 3 | 20 |
| Total, other adverse events | Clopidogrel | 3 | 55 |
| Total, other adverse events | Acetylsalicylic Acid - Cilostazol | 10 | 20 |
| Total, other adverse events | Clopidogrel - Cilostazol | 41 | 55 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02554721
GET https://conductscience.org/api/trials/v1/NCT02554721/registered