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

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Clinical Utility Of Caduet In Simultaneously Achieving Blood Pressure And Lipid Endpoints In A Specific Patient Population (CAPABLE)

The purpose is to demonstrate the utility of Caduet (amlodipine/atorvastatin) in the African American population

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35211
        • Pfizer Investigational Site
      • Huntsville, Alabama, United States, 35801
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Pfizer Investigational Site
    • California
      • Los Angeles, California, United States, 90024
        • Pfizer Investigational Site
      • Oakland, California, United States, 94609-3425
        • Pfizer Investigational Site
      • Pico Rivera, California, United States, 90660
        • Pfizer Investigational Site
    • Connecticut
      • Bridgeport, Connecticut, United States, 6610
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Pfizer Investigational Site
      • Washington, District of Columbia, United States, 20037
        • Pfizer Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Pfizer Investigational Site
      • Gainesville, Florida, United States, 32601
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32204
        • Pfizer Investigational Site
      • Orlando, Florida, United States, 32806
        • Pfizer Investigational Site
      • Pensacola, Florida, United States, 32503
        • Pfizer Investigational Site
      • Vero Beach, Florida, United States, 32960
        • Pfizer Investigational Site
    • Georgia
      • Athens, Georgia, United States, 30606
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30309
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30303
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30310
        • Pfizer Investigational Site
      • Augusta, Georgia, United States, 30904
        • Pfizer Investigational Site
      • Columbus, Georgia, United States, 31904
        • Pfizer Investigational Site
      • Columbus, Georgia, United States, 31901
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30033
        • Pfizer Investigational Site
      • Lincolnton, Georgia, United States, 30817
        • Pfizer Investigational Site
      • Savannah, Georgia, United States, 31406
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Pfizer Investigational Site
      • Chicago, Illinois, United States, 60637-1470
        • Pfizer Investigational Site
      • Maywood, Illinois, United States, 60153
        • Pfizer Investigational Site
    • Indiana
      • Merrillville, Indiana, United States, 46410
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Pfizer Investigational Site
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
        • Pfizer Investigational Site
      • New Orleans, Louisiana, United States, 70117-4817
        • Pfizer Investigational Site
      • New Orleans, Louisiana, United States, 70125
        • Pfizer Investigational Site
      • Shreveport, Louisiana, United States, 71101
        • Pfizer Investigational Site
      • Shreveport, Louisiana, United States, 71130
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Pfizer Investigational Site
      • Baltimore, Maryland, United States, 21215
        • Pfizer Investigational Site
      • Columbia, Maryland, United States, 21045
        • Pfizer Investigational Site
      • Randallstown, Maryland, United States, 21133
        • Pfizer Investigational Site
      • Rockville, Maryland, United States, 20850
        • Pfizer Investigational Site
      • Westminster, Maryland, United States, 21157
        • Pfizer Investigational Site
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Pfizer Investigational Site
      • Wellesley Hills, Massachusetts, United States, 02481-2106
        • Pfizer Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Pfizer Investigational Site
      • Detroit, Michigan, United States, 48235
        • Pfizer Investigational Site
      • Lansing, Michigan, United States, 48917
        • Pfizer Investigational Site
      • Livonia, Michigan, United States, 48152
        • Pfizer Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Pfizer Investigational Site
      • Jackson, Mississippi, United States, 39216
        • Pfizer Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Pfizer Investigational Site
      • Kansas City, Missouri, United States, 64112
        • Pfizer Investigational Site
      • Saint Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
      • Saint Louis, Missouri, United States, 63110
        • Pfizer Investigational Site
      • Saint Louis, Missouri, United States, 63104
        • Pfizer Investigational Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08034
        • Pfizer Investigational Site
      • East Orange, New Jersey, United States, 07018
        • Pfizer Investigational Site
      • Elizabeth, New Jersey, United States, 07202
        • Pfizer Investigational Site
      • Hammonton, New Jersey, United States, 08037
        • Pfizer Investigational Site
      • South Bound Brook, New Jersey, United States, 08880
        • Pfizer Investigational Site
      • Voorhees, New Jersey, United States, 08043
        • Pfizer Investigational Site
      • Woodbury, New Jersey, United States, 08096
        • Pfizer Investigational Site
    • New York
      • Brooklyn, New York, United States, 11203
        • Pfizer Investigational Site
      • Brooklyn, New York, United States
        • Pfizer Investigational Site
      • Buffalo, New York, United States, 14215
        • Pfizer Investigational Site
      • Mineola, New York, United States, 11501
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Pfizer Investigational Site
      • Greenville, North Carolina, United States, 27834
        • Pfizer Investigational Site
      • Monroe, North Carolina, United States
        • Pfizer Investigational Site
      • Monroe, North Carolina, United States, 28112
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103-3315
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45229
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45246
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45236
        • Pfizer Investigational Site
      • Dayton, Ohio, United States, 45402
        • Pfizer Investigational Site
      • Dayton, Ohio, United States, 45406
        • Pfizer Investigational Site
      • Maumee, Ohio, United States, 43537
        • Pfizer Investigational Site
      • Perrysburg, Ohio, United States, 43551
        • Pfizer Investigational Site
    • Pennsylvania
      • Bensalem, Pennsylvania, United States, 19020
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19148
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19146
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19141
        • Pfizer Investigational Site
    • South Carolina
      • Bamberg, South Carolina, United States, 29003
        • Pfizer Investigational Site
      • Charleston, South Carolina, United States, 29425
        • Pfizer Investigational Site
      • Clinton, South Carolina, United States, 29325
        • Pfizer Investigational Site
      • Mount Pleasant, South Carolina, United States, 29464
        • Pfizer Investigational Site
      • Simpsonville, South Carolina, United States, 29681
        • Pfizer Investigational Site
    • Tennessee
      • Bartlett, Tennessee, United States, 38134
        • Pfizer Investigational Site
      • Jackson, Tennessee, United States, 38305
        • Pfizer Investigational Site
    • Texas
      • Beaumont, Texas, United States, 77702
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75235
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75254
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77024
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77054
        • Pfizer Investigational Site
    • Virginia
      • Emporia, Virginia, United States, 23847
        • Pfizer Investigational Site
      • Norfolk, Virginia, United States, 23502
        • Pfizer Investigational Site
      • Norfolk, Virginia, United States, 23510
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23249
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23294
        • Pfizer Investigational Site
      • Virginia Beach, Virginia, United States, 23455
        • Pfizer Investigational Site
      • Virginia Beach, Virginia, United States, 23454
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3841025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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