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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Dyslipidemia

Intervention: Amlodipine/Atorvastatin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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: 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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Pfizer Investigational Site, Birmingham, Alabama 35209, United States

Pfizer Investigational Site, Birmingham, Alabama 35211, United States

Pfizer Investigational Site, Huntsville, Alabama 35801, United States

Pfizer Investigational Site, Little Rock, Arkansas 72204, United States

Pfizer Investigational Site, Los Angeles, California 90024, United States

Pfizer Investigational Site, Oakland, California 94609-3425, United States

Pfizer Investigational Site, Pico Rivera, California 90660, United States

Pfizer Investigational Site, Bridgeport, Connecticut 6610, United States

Pfizer Investigational Site, Washington, District of Columbia 20010, United States

Pfizer Investigational Site, Washington, District of Columbia 20037, United States

Pfizer Investigational Site, Aventura, Florida 33180, United States

Pfizer Investigational Site, Gainesville, Florida 32601, United States

Pfizer Investigational Site, Jacksonville, Florida 32204, United States

Pfizer Investigational Site, Orlando, Florida 32806, United States

Pfizer Investigational Site, Pensacola, Florida 32503, United States

Pfizer Investigational Site, Vero Beach, Florida 32960, United States

Pfizer Investigational Site, Athens, Georgia 30606, United States

Pfizer Investigational Site, Atlanta, Georgia 30303, United States

Pfizer Investigational Site, Atlanta, Georgia 30309, United States

Pfizer Investigational Site, Atlanta, Georgia 30310, United States

Pfizer Investigational Site, Atlanta, Georgia 30342, United States

Pfizer Investigational Site, Augusta, Georgia 30904, United States

Pfizer Investigational Site, Columbus, Georgia 31901, United States

Pfizer Investigational Site, Columbus, Georgia 31904, United States

Pfizer Investigational Site, Decatur, Georgia 30033, United States

Pfizer Investigational Site, Lincolnton, Georgia 30817, United States

Pfizer Investigational Site, Savannah, Georgia 31406, United States

Pfizer Investigational Site, Chicago, Illinois 60616, United States

Pfizer Investigational Site, Chicago, Illinois 60637-1470, United States

Pfizer Investigational Site, Maywood, Illinois 60153, United States

Pfizer Investigational Site, Merrillville, Indiana 46410, United States

Pfizer Investigational Site, Overland Park, Kansas 66211, United States

Pfizer Investigational Site, Bossier City, Louisiana 71111, United States

Pfizer Investigational Site, New Orleans, Louisiana 70117-4817, United States

Pfizer Investigational Site, New Orleans, Louisiana 70125, United States

Pfizer Investigational Site, Shreveport, Louisiana 71101, United States

Pfizer Investigational Site, Shreveport, Louisiana 71130, United States

Pfizer Investigational Site, Baltimore, Maryland 21201, United States

Pfizer Investigational Site, Baltimore, Maryland 21215, United States

Pfizer Investigational Site, Columbia, Maryland 21045, United States

Pfizer Investigational Site, Randallstown, Maryland 21133, United States

Pfizer Investigational Site, Rockville, Maryland 20850, United States

Pfizer Investigational Site, Westminster, Maryland 21157, United States

Pfizer Investigational Site, Brockton, Massachusetts 02301, United States

Pfizer Investigational Site, Wellesley Hills, Massachusetts 02481-2106, United States

Pfizer Investigational Site, Detroit, Michigan 48201, United States

Pfizer Investigational Site, Detroit, Michigan 48235, United States

Pfizer Investigational Site, Lansing, Michigan 48917, United States

Pfizer Investigational Site, Livonia, Michigan 48152, United States

Pfizer Investigational Site, Jackson, Mississippi 39216, United States

Pfizer Investigational Site, Jackson, Mississippi 39202, United States

Pfizer Investigational Site, Kansas City, Missouri 64112, United States

Pfizer Investigational Site, Kansas City, Missouri 64131, United States

Pfizer Investigational Site, St. Louis, Missouri 63104, United States

Pfizer Investigational Site, St. Louis, Missouri 63110, United States

Pfizer Investigational Site, St. Louis, Missouri 63141, United States

Pfizer Investigational Site, Cherry Hill, New Jersey 08034, United States

Pfizer Investigational Site, East Orange, New Jersey 07018, United States

Pfizer Investigational Site, Elizabeth, New Jersey 07202, United States

Pfizer Investigational Site, Hammonton, New Jersey 08037, United States

Pfizer Investigational Site, South Bound Brook, New Jersey 08880, United States

Pfizer Investigational Site, Voorhees, New Jersey 08043, United States

Pfizer Investigational Site, Woodbury, New Jersey 08096, United States

Pfizer Investigational Site, Brooklyn, New York, United States

Pfizer Investigational Site, Brooklyn, New York 11203, United States

Pfizer Investigational Site, Buffalo, New York 14215, United States

Pfizer Investigational Site, Mineola, New York 11501, United States

Pfizer Investigational Site, Charlotte, North Carolina 28209, United States

Pfizer Investigational Site, Greenville, North Carolina 27834, United States

Pfizer Investigational Site, Monroe, North Carolina 28112, United States

Pfizer Investigational Site, Monroe, North Carolina, United States

Pfizer Investigational Site, Winston-Salem, North Carolina 27103, United States

Pfizer Investigational Site, Winston-Salem, North Carolina 27103-3315, United States

Pfizer Investigational Site, Cincinnati, Ohio 45219, United States

Pfizer Investigational Site, Cincinnati, Ohio 45229, United States

Pfizer Investigational Site, Cincinnati, Ohio 45236, United States

Pfizer Investigational Site, Cincinnati, Ohio 45246, United States

Pfizer Investigational Site, Dayton, Ohio 45402, United States

Pfizer Investigational Site, Dayton, Ohio 45406, United States

Pfizer Investigational Site, Maumee, Ohio 43537, United States

Pfizer Investigational Site, Perrysburg, Ohio 43551, United States

Pfizer Investigational Site, Bensalem, Pennsylvania 19020, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania 19141, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania 19146, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania 19148, United States

Pfizer Investigational Site, Bamberg, South Carolina 29003, United States

Pfizer Investigational Site, Charleston, South Carolina 29425, United States

Pfizer Investigational Site, Clinton, South Carolina 29325, United States

Pfizer Investigational Site, Mt. Pleasant, South Carolina 29464, United States

Pfizer Investigational Site, Simpsonville, South Carolina 29681, United States

Pfizer Investigational Site, Bartlett, Tennessee 38134, United States

Pfizer Investigational Site, Jackson, Tennessee 38305, United States

Pfizer Investigational Site, Beaumont, Texas 77702, United States

Pfizer Investigational Site, Dallas, Texas 75235, United States

Pfizer Investigational Site, Dallas, Texas 75254, United States

Pfizer Investigational Site, Houston, Texas 77054, United States

Pfizer Investigational Site, Houston, Texas 77030, United States

Pfizer Investigational Site, Houston, Texas 77024, United States

Pfizer Investigational Site, Emporia, Virginia 23847, United States

Pfizer Investigational Site, Norfolk, Virginia 23502, United States

Pfizer Investigational Site, Norfolk, Virginia 23510, United States

Pfizer Investigational Site, Richmond, Virginia 23249, United States

Pfizer Investigational Site, Richmond, Virginia 23294, United States

Pfizer Investigational Site, Viginia Beach, Virginia 23455, United States

Pfizer Investigational Site, Virginia Beach, Virginia 23454, United States

Pfizer Investigational Site, Milwaukee, Wisconsin 53209, United States

Additional Information

Starting date: July 2004
Last updated: April 21, 2015

Page last updated: August 20, 2015

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