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Completed

NCT Number: NCT00407537

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

35 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Desamparados, Provincia de San José, Costa Rica

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amlodipine besylate/atorvastatin calcium single pill combination

Drug

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

Primary outcomes

  1. 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

  1. Framingham 10-year Risk of Total CHD at Month 4

    Time frame: 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).

  2. European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12

    Time frame: 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).

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

    Time frame: 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).

  4. Framingham 10-year Risk of Stroke at Month 12

    Time frame: 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).

  5. Framingham 10-year Risk of Stroke at Month 4

    Time frame: 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).

  6. Change From Baseline in Framingham 10-year Risk of Developing Total CHD

    Time frame: 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.

  7. Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD

    Time frame: 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.

  8. Mean Systolic and Diastolic Blood Pressure at Month 4

    Time frame: Month 4

  9. Mean Systolic and Diastolic Blood Pressure at Month 12

    Time frame: Month 12

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

    Time frame: Baseline, Month 4

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

    Time frame: Baseline, Month 4

  12. Change From Baseline in SBP at Month 12

    Time frame: Baseline, Month 12

  13. Change From Baseline in DBP at Month 12

    Time frame: Baseline, Month 12

  14. Mean Lipid Parameters at Month 4

    Time frame: Month 4

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

  15. Mean Lipid Parameters at Month 12

    Time frame: Month 12

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

  16. Change From Baseline in Lipid Parameters at Month 4

    Time frame: 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.

  17. Change From Baseline in Lipid Parameters at Month 12

    Time frame: Baseline, Month 12

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

  18. Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months

    Time frame: 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.

  19. Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months

    Time frame: 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.

  20. Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months

    Time frame: Month 4, Month 12

    Treatments indicative of prescribed medications other than study provided Caduet.

  21. Number of Participants With Increase of Treatment Dosages After 4 Months.

    Time frame: Month 4

    Treatments indicative of prescribed medications other than study provided Caduet.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Acronym: CRUCIAL

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 5, 2006
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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