Cardiovascular Risk Assessment in Patients Treated With Caduet
NCT00297973
ABOUT THIS STUDY
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- 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,
- 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,
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Descriptive Information | ||||
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Brief Title ICMJE | Cardiovascular Risk Assessment in Patients Treated With Caduet | |||
Official Title ICMJE | Cardiovascular Risk Assessment In Patients With Hypertension And At Least Three Other Risk Factors, Treated With Caduet Compared To Usual Care: The Right Study | |||
Brief Summary | Compare the reduction in Framingham's predicted 10-year risk of a coronary event (6) in patients with hypertension and at least three other cardiovascular risk factors (including diabetic patients) seen in private practice and randomized to either Caduet or usual care. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
Condition ICMJE | Hypertension | |||
Intervention ICMJE |
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Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 1442 | |||
Original Enrollment ICMJE | 6200 | |||
Actual Study Completion Date ICMJE | April 2007 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00297973 | |||
Other Study ID Numbers ICMJE | A3841038 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | April 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |