Cardiovascular Risk Assessment in Patients Treated With Caduet (RIGHT)

Tracking Information
First Submitted Date ICMJE	February 27, 2006
First Posted Date ICMJE	March 1, 2006
Last Update Posted Date	March 30, 2009
Study Start Date ICMJE	February 2006
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: February 27, 2006)	% 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; (submitted: February 27, 2006)	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
Actual Enrollment ICMJE; (submitted: March 27, 2009)	1442
Original Enrollment ICMJE; (submitted: February 27, 2006)	6200
Actual Study 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	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	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