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Main
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Note: This record shows only the 20 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00348855 |
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Date of registration:
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03/07/2006 |
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Primary sponsor: |
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Public title:
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Study to Improve Quality of Care and Patient Health in the Field of Cardiovascular Risk Factors in General Practice
ESCAPE |
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Scientific title:
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Effects of a Series of Intensified Prevention Consultations on the Changes in Goals and Risk Factors in Hypertensive Patients at High Cardiovascular Risk |
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Date of first enrolment:
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November 2006 |
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Target sample size:
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1836 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00348855 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
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Countries of recruitment
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France
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Contacts
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Name:
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Michel LIEVRE, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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EZUS LYON |
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Name:
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Denis POUCHAIN, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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French National College of GP Teatchers |
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Name:
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Dominique HUAS, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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French National College of GP Teatchers |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Treated High blood Pressure patients with at least two other cardiovascular risks
Exclusion Criteria:
- Secondary prevention
Age minimum:
40 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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High Risk Hypertensive Patients
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Intervention(s)
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Behavioral: Compliance
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Behavioral: Diet
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Behavioral: Exercise
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Behavioral: Stop Smoking
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Other: Cardiovascular drugs strategies
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Other: Feed Back
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Primary Outcome(s)
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Number of patients who reach all the therapeutic goals defined by the guidelines in the total study population, in the sub-group of patients with hypertension, but free of type-2 diabetes (T2D), and in the sub-group with hypertension and T2D.
[Time Frame: At inclusion, year 1 and year 2]
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Secondary Outcome(s)
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Compliance
[Time Frame: At inclusion, year 1 and year 2]
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Diet
[Time Frame: At inclusion, year 1 and year 2]
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Exercise
[Time Frame: At inclusion, year 1 and year 2]
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Levels of blood pressure, LDL-Cholesterol, tobacco consumption in the whole population plus levels of HbA1c and aspirin use in the TD2 population
[Time Frame: inclusion, year 1 and year 2]
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Number of targets reached by the patients
[Time Frame: At inclusion, year 1 and year 2]
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Quality of life measured with SF8
[Time Frame: At inclusion, year 1 and year 2]
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Secondary ID(s)
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CNGE20060702
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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