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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: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2004-000822-58-IT
Date of registration: 15/09/2004
Prospective Registration: Yes
Primary sponsor: BRISTOL-M.SQUIBB
Public title: A double-blind, randomized study of clopidogrel 75 mg/d vs placebo, on a background of ASA 75-100 mg/d, in peripheral arterial disease (PAD) patients receiving a unilateral below knee bypass graft. The CASPAR 2004 study (Clopidogrel and Acetyl salicylic acid in bypass Surgery for Peripheral ARterial disease)
Scientific title: A double-blind, randomized study of clopidogrel 75 mg/d vs placebo, on a background of ASA 75-100 mg/d, in peripheral arterial disease (PAD) patients receiving a unilateral below knee bypass graft. The CASPAR 2004 study (Clopidogrel and Acetyl salicylic acid in bypass Surgery for Peripheral ARterial disease)
Date of first enrolment: 04/10/2004
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000822-58
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:  
Phase: 
Countries of recruitment
Finland Hungary Italy Spain Sweden
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Treatment of patients with peripheral arterial disease (PAD),already treated with ASA 75-100 mg/d,receiving a unilateral below knee bypass graft.
MedDRA version: 6.1 Level: PT Classification code 10003604
Intervention(s)

Trade Name: Clopidogrel
Product Name: clopidogrel
Product Code: NA
Pharmaceutical Form: Tablet
INN or Proposed INN: clopidogrel
CAS Number: 113665-84-2
Current Sponsor code: SR25990C
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-

Primary Outcome(s)
Secondary Objective:
Main Objective:
Primary end point(s):
Secondary Outcome(s)
Secondary ID(s)
2004-000822-58-SE
C9253
Source(s) of Monetary Support
Secondary Sponsor(s)
SANOFI-SYNTHELABO
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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