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

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: September 6, 2005
Last updated: April 21, 2015
Last verified: April 2015
The purpose is to demonstrate the utility of Caduet (amlodipine/atorvastatin) in the African American population

Condition Intervention Phase
Drug: Amlodipine/Atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 500
Study Start Date: July 2004
Study Completion Date: August 2005

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00150384

  Show 106 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Responsible Party: Pfizer Identifier: NCT00150384     History of Changes
Other Study ID Numbers: A3841025 
Study First Received: September 6, 2005
Last Updated: April 21, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine, atorvastatin drug combination
Anticholesteremic Agents
Antihypertensive Agents
Calcium Channel Blockers
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents processed this record on May 26, 2016