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

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ClinicalTrials.gov Identifier: NCT00407537
Recruitment Status : Completed
First Posted : December 5, 2006
Results First Posted : November 11, 2011
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Hypercholesterolemia Drug: Amlodipine besylate/atorvastatin calcium single pill combination Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1531 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : March 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Caduet
Open label caduet added to usual care regimen followed by investigators.
 Drug: Amlodipine besylate/atorvastatin calcium single pill combination
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407537


Locations
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Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier: NCT00407537    
Other Study ID Numbers: A3841047
First Posted: December 5, 2006    Key Record Dates
Results First Posted: November 11, 2011
Last Update Posted: January 28, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
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Hypertension
Hypercholesterolemia
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine
Atorvastatin
Calcium
Calcium-Regulating Hormones and Agents
 Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents