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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1,531 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,531

Conditions

Hypertension Hypercholesterolemia

Interventions

Amlodipine besylate/atorvastatin calcium single pill combinationDRUG

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

Eligibility

Sex: ALLMin age: 35 YearsMax age: 79 Years

Medical Language ↔ Plain English

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.

Locations (125)

Outcomes

Primary Outcomes

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).

Time frame: Baseline, Month 12

Secondary Outcomes

Framingham 10-year Risk of Total CHD at Month 4

Time frame: 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).

Time frame: Baseline, Month 12

European SCORE 10-year Risk of Fatal CVD at Month 4

Time frame: Baseline, Month 4

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Desamparados, Provincia de San José, Costa Rica

Pfizer Investigational Site

Heredia, Costa Rica

Pfizer Investigational Site

San José, Costa Rica

Pfizer Investigational Site

Breznički Hum, Croatia

Pfizer Investigational Site

Crikvenica, Croatia

Pfizer Investigational Site

Čakovec, Croatia

Pfizer Investigational Site

Karlovac, Croatia

Pfizer Investigational Site

Rijeka, Croatia

Pfizer Investigational Site

Split, Croatia

Pfizer Investigational Site

Sveti Križ Začretje, Croatia

...and 115 more locations

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).

Time frame: Baseline, Month 12

Framingham 10-year Risk of Stroke at Month 4

Time frame: 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.

Time frame: 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.

Time frame: Baseline, Month 4, Month 12

Mean Systolic and Diastolic Blood Pressure at Month 4

Time frame: Month 4

Mean Systolic and Diastolic Blood Pressure at Month 12

Time frame: Month 12

Change From Baseline in Systolic Blood Pressure (SBP) at Month 4

Time frame: Baseline, Month 4

Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4

Time frame: Baseline, Month 4

Change From Baseline in SBP at Month 12

Time frame: Baseline, Month 12

Change From Baseline in DBP at Month 12

Time frame: 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.

Time frame: Month 4

Mean Lipid Parameters at Month 12

Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Month 4