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

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 Type : Interventional  (Clinical Trial)
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
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00150384

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Responsible Party: Pfizer 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:
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Amlodipine, atorvastatin drug combination
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents