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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01138969
Date of registration: 07/06/2010
Prospective Registration: No
Primary sponsor: Kaohsiung Veterans General Hospital.
Public title: Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer
Scientific title: Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer and Gastrointestinal Bleeding
Date of first enrolment: August 2008
Target sample size: 165
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01138969
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
Taiwan
Contacts
Name:     Kwok-Hung Lai, MD
Address: 
Telephone:
Email:
Affiliation:  Kaohsiung Veterans General Hospital.
Key inclusion & exclusion criteria

Inclusion Criteria:

- We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at
initial endoscopy. The patients will be randomly assigned to receive either (1)
esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6
months.

Exclusion Criteria:

- 1.serious disease 2.refuse informed consent



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Peptic Ulcer
Intervention(s)
Drug: esomeprazole
Primary Outcome(s)
Recurrent Peptic Ulcer [Time Frame: 6 months]
Secondary Outcome(s)
Peptic Ulcer Bleeding [Time Frame: 6 months]
Secondary ID(s)
VGHKS98-CT6-12
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 04/02/2013
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01138969
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