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Clinical Utility of Caduet in Achieving Blood Pressure and Lipid Endpoints in a Specific Patient Population (CAPABLE)
This study has been completed.
First Received: September 6, 2005   Last Updated: April 17, 2007   History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00150384
  Purpose

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


Condition Intervention Phase
Hypertension
Dyslipidemia
 Drug: Amlodipine/Atorvastatin
 Phase IV

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Lipids Amlodipine Amlodipine besylate Atorvastatin Atorvastatin calcium Caduet
U.S. FDA Resources

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
Estimated Study Completion Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150384

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

Additional Information:
Link to ClinicalStudyResults.org Posting  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: A3841025
Study First Received: September 6, 2005
Last Updated: April 17, 2007
ClinicalTrials.gov Identifier: NCT00150384     History of Changes
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2009



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