Clinical trial NCT00297973: Cardiovascular Risk Assessment in Patients Treated With Caduet
Official title: Cardiovascular Risk Assessment In Patients With Hypertension And At Least Three Other Risk Factors, Treated With Caduet Compared To Usual Care: The Right Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-03-01
Enrollment: 1442
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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,

Primary outcomes:
measure: % 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)
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Abbeville
country: France
facility: Pfizer Investigational Site
city: Aire Sur La Lys
country: France
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city: Aix Les Bains
country: France
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facility: Pfizer Investigational Site
city: Suresnes
country: France
facility: Pfizer Investigational Site
city: Targon
country: France
facility: Pfizer Investigational Site
city: Tergnier
country: France
facility: Pfizer Investigational Site
city: Thiant
country: France
facility: Pfizer Investigational Site
city: Thierville Sur Meuse
country: France
facility: Pfizer Investigational Site
city: Thiviers
country: France
facility: Pfizer Investigational Site
city: Thones
country: France
facility: Pfizer Investigational Site
city: Toulon
country: France
facility: Pfizer Investigational Site
city: Toulon
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Toul
country: France
facility: Pfizer Investigational Site
city: Tours
country: France
facility: Pfizer Investigational Site
city: Trie Sur Baise
country: France
facility: Pfizer Investigational Site
city: Vabres L'Abbaye
country: France
facility: Pfizer Investigational Site
city: Vacqueyras
country: France
facility: Pfizer Investigational Site
city: Vagney
country: France
facility: Pfizer Investigational Site
city: Valenciennes
country: France
facility: Pfizer Investigational Site
city: Valognes
country: France
facility: Pfizer Investigational Site
city: Valreas
country: France
facility: Pfizer Investigational Site
city: Vals Les Bains
country: France
facility: Pfizer Investigational Site
city: Vandoeuvre Les Nancy
country: France
facility: Pfizer Investigational Site
city: Vannes
country: France
facility: Pfizer Investigational Site
city: Varces Allieres Et Risset
country: France
facility: Pfizer Investigational Site
city: Vatan
country: France
facility: Pfizer Investigational Site
city: Velines
country: France
facility: Pfizer Investigational Site
city: Velizy Villacoublay
country: France
facility: Pfizer Investigational Site
city: Vence
country: France
facility: Pfizer Investigational Site
city: Venissieux
country: France
facility: Pfizer Investigational Site
city: Vernet
country: France
facility: Pfizer Investigational Site
city: Viane
country: France
facility: Pfizer Investigational Site
city: Villard Bonnot
country: France
facility: Pfizer Investigational Site
city: Villefranche de Rouergue
country: France
facility: Pfizer Investigational Site
city: Villefranche Sur Mer
country: France
facility: Pfizer Investigational Site
city: Villefranche Sur Saone
country: France
facility: Pfizer Investigational Site
city: Villeneuve Les Maguelone
country: France
facility: Pfizer Investigational Site
city: Villeparisis
country: France
facility: Pfizer Investigational Site
city: Villers St. Paul
country: France
facility: Pfizer Investigational Site
city: Villette D'Anthon
country: France
facility: Pfizer Investigational Site
city: Viry Chatillon
country: France
facility: Pfizer Investigational Site
city: Vitrolles
country: France
facility: Pfizer Investigational Site
city: Vix
country: France
facility: Pfizer Investigational Site
city: Wambrechies
country: France
facility: Pfizer Investigational Site
city: Wasselonne
country: France
facility: Pfizer Investigational Site
city: Wattignies
country: France
facility: Pfizer Investigational Site
city: Wattrelos
country: France
facility: Pfizer Investigational Site
city: Witry Les Reims
country: France
facility: Pfizer Investigational Site
city: Yffiniac
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: