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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypertension, Hypercholesterolemia

Intervention / Treatment
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* Drug: Amlodipine besylate/atorvastatin calcium single pill combination


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caduet<br>Open label caduet added to usual care regimen followed by investigators. | Drug: Amlodipine besylate/atorvastatin calcium single pill combination<br>* Open label amlodipine besylate/atorvastatin calcium single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at 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). | Baseline, Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Framingham 10-year Risk of Total CHD at 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). | Baseline, Month 4 | 
| European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at 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). | Baseline, Month 12 | 
| European SCORE 10-year Risk of Fatal CVD at 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). | Baseline, Month 4 | 
| Framingham 10-year Risk of Stroke at 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). | Baseline, Month 12 | 
| Framingham 10-year Risk of Stroke at 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). | Baseline, Month 4 | 
| Change From Baseline in Framingham 10-year Risk of Developing Total CHD | 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. | Baseline, Month 4, Month 12 | 
| Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD | 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. | Baseline, Month 4, Month 12 | 
| Mean Systolic and Diastolic Blood Pressure at Month 4 |  | Month 4 | 
| 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 | 
| 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 | 
| Mean Lipid Parameters at Month 4 | Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. | Month 4 | 
| Mean Lipid Parameters at Month 12 | Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. | Month 12 | 
| Change From Baseline in Lipid Parameters at 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. | Baseline, Month 4 | 
| Change From Baseline in Lipid Parameters at Month 12 | Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. | Baseline, Month 12 | 
| Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months | 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. | Month 4, Month 12 | 
| Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months | 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. | Month 4, Month 12 | 
| Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months | Treatments indicative of prescribed medications other than study provided Caduet. | Month 4, Month 12 | 
| Number of Participants With Increase of Treatment Dosages After 4 Months. | Treatments indicative of prescribed medications other than study provided Caduet. | Month 4 |