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Clinical Utility of Caduet in Achieving Blood Pressure and Lipid Endpoints in a Specific Patient Population (CAPABLE)

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.
ClinicalTrials.gov Identifier: NCT00150384
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : April 22, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose is to demonstrate the utility of Caduet (amlodipine/atorvastatin) in the African American population

Condition or disease Intervention/treatment Phase
Hypertension Dyslipidemia Drug: Amlodipine/Atorvastatin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Utility Of Caduet In Simultaneously Achieving Blood Pressure And Lipid Endpoints In A Specific Patient Population (CAPABLE)
Study Start Date : July 2004
Study Completion Date : August 2005

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. To evaluate the efficacy of Caduet therapy by assessing the percentage of intent-to-treat subjects achieving both BP and lipid treatment goals (JNC VII and NCEP ATP III)

Secondary Outcome Measures :
  1. To assess the percentage of subjects achieving treatment goals(JNC VII and NCEP) stratified by the final BP and lipid therapy doses, respectively, the change from baseline in lipid profile, SBP and DBP

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • African American men and women with concurrent hypertension and dyslipidemia that is either treated or untreated
  • Subjects must satisfy the blood pressure and LDL-C inclusion criteria for their respective Cardiovascular Risk group determined at screening

Exclusion Criteria:

  • Subjects currently being treated with concomitant amlodipine and atorvastatin therapy, including Caduet
  • Subjects with blood pressure at goal
Contacts and Locations

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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): NCT00150384


  Show 106 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00150384     History of Changes
Other Study ID Numbers: A3841025
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
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