Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors

Phase 4

Completed

• Conditions: Hypertension; Hypercholesterolemia
• Interventions: Drug: Amlodipine besylate/atorvastatin calcium single pill combination

• Registration Number: NCT00407537
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-12-01
• Study First Submitted QC: 2006-12-04
• Study First Posted: 2006-12-05
• Study Start: 2007-03
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2010-10-06
• Results First Submitted QC: 2011-10-05
• Results First Posted: 2011-11-11
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1531

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caduet	Amlodipine besylate/atorvastatin calcium single pill combination	Open label caduet added to usual care regimen followed by investigators.

Primary Outcome Measures

Name	Time	Method
Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12	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 Outcome Measures

Name	Time	Method
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	Goal set at \<100 mg/dL according to the United States (US) National Cholesterol Education Program Adult Treatment Panel 3 and at \<80 mg/dL according to the European (EU) Society of Cardiology guidelines.
Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months	Month 4, Month 12	Treatments indicative of prescribed medications other than study provided Caduet.
Mean Systolic and Diastolic Blood Pressure at Month 12	Month 12
Change From Baseline in Systolic Blood Pressure (SBP) at Month 4	Baseline, Month 4
Mean Lipid Parameters at Month 12	Month 12	Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
Change From Baseline in Lipid Parameters at Month 4	Baseline, Month 4	Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. Change from baseline measured as mean at Month 4 minus mean at Baseline.
Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4	Baseline, Month 4
Framingham 10-year Risk of Total CHD at Month 4	Baseline, Month 4	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 after 4 months of treatment (Month 4).
European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12	Baseline, Month 12	European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 12 months of study treatment (Month 12).
European SCORE 10-year Risk of Fatal CVD at Month 4	Baseline, Month 4	European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 4 months of study treatment (Month 4).
Framingham 10-year Risk of Stroke at Month 12	Baseline, Month 12	Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific "calibration factor" for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).
Framingham 10-year Risk of Stroke at Month 4	Baseline, Month 4	Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific "calibration factor" for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).
Change From Baseline in Framingham 10-year Risk of Developing Total CHD	Baseline, Month 4, 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. Change from baseline calculated as mean at observation minus mean at Baseline.
Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD	Baseline, Month 4, Month 12	European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. Change from baseline calculated as mean at observation minus mean at Baseline.
Mean Systolic and Diastolic Blood Pressure at Month 4	Month 4
Mean Lipid Parameters at Month 4	Month 4	Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
Number of Participants With Increase of Treatment Dosages After 4 Months.	Month 4	Treatments indicative of prescribed medications other than study provided Caduet.
Change From Baseline in Lipid Parameters at Month 12	Baseline, Month 12	Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
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	Goals set at \<140/90 mmHg according to the seventh Joint National Committee (JNC) on prevention, detection, evaluation, and treatment of high blood pressure and \<140/90 mm Hg or \<130/80 mm Hg for diabetics ccording to the European Society of Cardiology (ESC) guidelines.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇻🇪 Valencia, Estado Carabobo, Venezuela