Condition category
Circulatory System
Date applied
31/07/2007
Date assigned
17/09/2007
Last edited
15/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ji-Young Park

ORCID ID

Contact details

126-1
Anam-dong 5-ga
Sungbuk-gu
Seoul
136-705
Korea
South
+82 2 920 6288
jypark21@korea.ac.kr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PGX-CPG-101

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the pharmacogenetic effect of CYP2C19 gene on the Pharmacokinetics (PK) / Pharmacodynamics (PD) of clopidogrel. The original target was the patients with cardiovascular diseases taking clopidogrel. However, due to the limitation of enrollment the trial was conducted with healthy subjects with different CYP2C19 genotype to demonstrate that the effect of clopidogrel varies according to the patient's CYP2C19 genotype.

Ethics approval

The Institutional Review Board of Anam Hospital, Korea University College of Medicine, Seoul, Korea, approved on 12 February 2007 (ref: AN-06151-001).

Study design

Open-label, parallel, multiple-dose comparative study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cardiovascular diseases

Intervention

After a loading dose of clopidogrel (300 mg; oral), patients will take a standard dose of clopidogrel 75 mg once a day for 6 days.

The following will be carried out:
1. Assessment of PK of clopidogrel and its metabolite SR26334
2. Measurement of the inhibition of ADP induced platelet aggregation by clopidogrel for 15 days
3. Evaluation of CYP2C19 phenotyping test using omperazole hydroxylation as a CYP2C19 probe

Intervention type

Drug

Phase

Not Specified

Drug names

CYP2C19 gene

Primary outcome measures

Genetic association with biological effect of clopidogrel.

Secondary outcome measures

PK/PD relationship.

Overall trial start date

01/03/2007

Overall trial end date

31/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy male subjects aged between 19 to 55
2. Wish to participate in the study
3. Informed consent for the trial

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

24

Participant exclusion criteria

1. A history of or currently active clinically significant cardiac (including clinically significant abnormalities on Electrocardiogram [ECG] according to Principal Investigator [PI]), pulmonary, gastrointestinal, hepatic, renal, pancreatic, or neurological disease
2. Heavy smoker and alcohol consumer
3. Use of anticoagulants or medication within the last 1 month

Recruitment start date

01/03/2007

Recruitment end date

31/08/2007

Locations

Countries of recruitment

Korea, South

Trial participating centre

126-1
Seoul
136-705
Korea, South

Sponsor information

Organisation

Korea University (South Korea)

Sponsor details

126-1
Anam-dong 5-ga
Sungbuk-gu
Seoul
136-705
Korea
South
+82 2 920 5114
webmaster@kumc.or.kr

Sponsor type

University/education

Website

http://www.korea.ac.kr/~eng/main.htm

Funders

Funder type

Government

Funder name

Anam Hospital, Korea University College of Medicine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Korea Health 21 Research and Development Project, Ministry of Health and Welfare (South Korea)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes