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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00407537
First Posted: December 5, 2006
Last Update Posted: July 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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 Intervention Phase
Hypertension Hypercholesterolemia Drug: Amlodipine besylate/atorvastatin calcium single pill combination Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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:
  • 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).

  • 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).

  • 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).

  • 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).

  • 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).

  • 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.

  • 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.

  • 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 [ Time Frame: Month 4 ]
    Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 1531
Study Start Date: March 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 79 Years   (Adult, Senior)
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
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


  Show 126 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00407537     History of Changes
Other Study ID Numbers: A3841047
First Submitted: December 1, 2006
First Posted: December 5, 2006
Results First Submitted: October 6, 2010
Results First Posted: November 11, 2011
Last Update Posted: July 23, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Hypertension
Hypercholesterolemia
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Amlodipine, atorvastatin drug combination
Amlodipine
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