Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00407537
First received: December 1, 2006
Last updated: October 5, 2011
Last verified: October 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Mean Systolic and Diastolic Blood Pressure at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Systolic Blood Pressure (SBP) at Month 4 [ Time Frame: Baseline, Month 4 ] [ Designated as safety issue: No ]
  • Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4 [ Time Frame: Baseline, Month 4 ] [ Designated as safety issue: No ]
  • Change From Baseline in SBP at Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in DBP at Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
  • Mean Lipid Parameters at Month 4 [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   35 Years to 79 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407537

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

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional 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
Study First Received: December 1, 2006
Results First Received: October 6, 2010
Last Updated: October 5, 2011
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Hypercholesterolemia
Hypertension
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Amlodipine, atorvastatin drug combination
Atorvastatin
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on May 22, 2013