A Cluster Randomized Trial On Cardiovascular Risk Factor Management: Caduet Versus Usual Care In Subjects With Hypertension And Additional Cardiovascular Risk Factors In Clinical Practice

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country1,531 target enrollmentMarch 2007

ConditionsHypertension Hypercholesterolemia

InterventionsAmlodipine besylate/atorvastatin calcium single pill combination

DrugsAmlodipine besylate/atorvastatin calcium single pill combination

Overview

Phase: Phase 4
Intervention: Amlodipine besylate/atorvastatin calcium single pill combination
Conditions: Hypertension
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 1531
Locations: 1
Primary Endpoint: Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To investigate whether a Caduet based treatment strategy might result in greater reduction in total cardiovascular risk as compared to usual care in subjects with hypertension and additional risk factors.

Registry

clinicaltrials.gov

Start Date

March 2007

End Date

October 2009

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Hypertension with three additional risks factors (for example: smoking, type 2 diabetes, family history of early heart disease, history of stroke, age over 55 (men) and 65 (women)

Exclusion Criteria

•Subjects currently receiving a statin or stopped statin within 6 months prior to enrollment.
•Subjects with a history of myocardial infarction and subjects with coronary bypass graft or intra-coronary interventions.

Arms & Interventions

Caduet

Open label caduet added to usual care regimen followed by investigators.

Intervention: Amlodipine besylate/atorvastatin calcium single pill combination

Outcomes

Primary Outcomes

Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12

Time Frame: Baseline, Month 12

Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated at the end of study treatment (Month 12).

Secondary Outcomes

Change From Baseline in Systolic Blood Pressure (SBP) at Month 4(Baseline, Month 4)
Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4(Baseline, Month 4)
Change From Baseline in SBP at Month 12(Baseline, Month 12)
Change From Baseline in DBP at Month 12(Baseline, Month 12)
Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months(Month 4, Month 12)
Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months(Month 4, Month 12)
Mean Lipid Parameters at Month 12(Month 12)
Change From Baseline in Lipid Parameters at Month 4(Baseline, Month 4)
Mean Systolic and Diastolic Blood Pressure at Month 12(Month 12)
Framingham 10-year Risk of Total CHD at Month 4(Baseline, Month 4)
European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12(Baseline, Month 12)
European SCORE 10-year Risk of Fatal CVD at Month 4(Baseline, Month 4)
Framingham 10-year Risk of Stroke at Month 12(Baseline, Month 12)
Framingham 10-year Risk of Stroke at Month 4(Baseline, Month 4)
Change From Baseline in Framingham 10-year Risk of Developing Total CHD(Baseline, Month 4, Month 12)
Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD(Baseline, Month 4, Month 12)
Mean Systolic and Diastolic Blood Pressure at Month 4(Month 4)
Mean Lipid Parameters at Month 4(Month 4)
Number of Participants With Increase of Treatment Dosages After 4 Months.(Month 4)
Change From Baseline in Lipid Parameters at Month 12(Baseline, Month 12)
Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months(Month 4, Month 12)