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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 February 2021 |
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Main ID: |
NCT00297973 |
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Date of registration:
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27/02/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cardiovascular Risk Assessment in Patients Treated With Caduet
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Scientific title:
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Cardiovascular Risk Assessment In Patients With Hypertension And At Least Three Other Risk Factors, Treated With Caduet Compared To Usual Care: The Right Study |
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Date of first enrolment:
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February 2006 |
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Target sample size:
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1442 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00297973 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 4
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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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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 1.Male or female, 18 years of age or over, 2.Patient with hypertension and at least
three other CV risk factors, 3.Hypertension, treated or not, but not at the currently
recommended goals (140/90 mmHg for most patients, 130/80 mmHg for patients with
diabetes or nephropathy). In case of treated hypertension, patients should be on their
current treatment for at least 4 weeks before randomisation,
Exclusion Criteria:
- 1. Patient with a history of coronary heart disease, 2.Patients with a history of
familial hypercholesterolemia, 3.Patient with malignant HTN, 4.Non-essential
hypertension, 5.Known hypersensitivity to dihydropyridines, 6.Patients already
receiving a dihydropyridine, 7.Known hypersensitivity to HMG-CoA-reductase inhibitors,
8.Patients currently receiving or who has received a HMG-CoA-reductase within the 3
months prior to selection, 9.Patients currently receiving or who has received a fibric
acid, resins, ezetimibe, nicotinic acid and all other drug which is known to affect
lipid levels, within 6 weeks prior to selection,
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Procedure: Blood samples
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Procedure: Blood pressure measurements
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Primary Outcome(s)
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% reduction in Framingham's predicted 10-year risk of a coronary event between V1 and V3 in the Caduet group compared to the usual care group (6) (including diabetic patients)
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Secondary Outcome(s)
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1. % patients changing risk category between V1 and V3 2. % reduction in Framingham's predicted 10-year risk of a coronary event (8) excluding diabetic patients 3. Clinical and biological safety during treatment period
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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