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Cardiovascular Risk Assessment in Patients Treated With Caduet

Cardiovascular Risk Assessment In Patients With Hypertension And At Least Three Other Risk Factors, Treated With Caduet Compared To Usual Care: The Right Study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00297973
Acronym
RIGHT
Enrollment
1442
Registered
2006-03-01
Start date
2006-02-28
Completion date
2007-04-30
Last updated
2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

PROCEDUREBlood samples

Sponsors

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frame
% 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

MeasureTime frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026