Cardiovascular Risk Assessment in Patients Treated With Caduet (RIGHT)

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00297973

First received: February 27, 2006

Last updated: March 27, 2009

Last verified: April 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

February 27, 2006

Last Updated Date

March 27, 2009

Start Date ^ICMJE

February 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

% 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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00297973 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

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

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Procedure: Blood pressure measurements
Procedure: Blood samples

Study Arms

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

Enrollment ^ICMJE

1442

Completion Date

April 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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,

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

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

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

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

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