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NCT00150384 Clinical Trial

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

Hypertension Clinical Trial

— CAPABLE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00150384
Other study ID # A3841025
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 2004
Est. completion date August 2005

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date August 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Amlodipine/Atorvastatin

Locations
Country Name City State
United States Pfizer Investigational Site Athens Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Augusta Georgia
United States Pfizer Investigational Site Aventura Florida
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Bamberg South Carolina
United States Pfizer Investigational Site Bartlett Tennessee
United States Pfizer Investigational Site Beaumont Texas
United States Pfizer Investigational Site Bensalem Pennsylvania
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Bossier City Louisiana
United States Pfizer Investigational Site Bridgeport Connecticut
United States Pfizer Investigational Site Brockton Massachusetts
United States Pfizer Investigational Site Brooklyn New York
United States Pfizer Investigational Site Brooklyn New York
United States Pfizer Investigational Site Buffalo New York
United States Pfizer Investigational Site Charleston South Carolina
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Cherry Hill New Jersey
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Clinton South Carolina
United States Pfizer Investigational Site Columbia Maryland
United States Pfizer Investigational Site Columbus Georgia
United States Pfizer Investigational Site Columbus Georgia
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dayton Ohio
United States Pfizer Investigational Site Dayton Ohio
United States Pfizer Investigational Site Decatur Georgia
United States Pfizer Investigational Site Detroit Michigan
United States Pfizer Investigational Site Detroit Michigan
United States Pfizer Investigational Site East Orange New Jersey
United States Pfizer Investigational Site Elizabeth New Jersey
United States Pfizer Investigational Site Emporia Virginia
United States Pfizer Investigational Site Gainesville Florida
United States Pfizer Investigational Site Greenville North Carolina
United States Pfizer Investigational Site Hammonton New Jersey
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Huntsville Alabama
United States Pfizer Investigational Site Jackson Mississippi
United States Pfizer Investigational Site Jackson Mississippi
United States Pfizer Investigational Site Jackson Tennessee
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Kansas City Missouri
United States Pfizer Investigational Site Kansas City Missouri
United States Pfizer Investigational Site Lansing Michigan
United States Pfizer Investigational Site Lincolnton Georgia
United States Pfizer Investigational Site Little Rock Arkansas
United States Pfizer Investigational Site Livonia Michigan
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Maumee Ohio
United States Pfizer Investigational Site Maywood Illinois
United States Pfizer Investigational Site Merrillville Indiana
United States Pfizer Investigational Site Milwaukee Wisconsin
United States Pfizer Investigational Site Mineola New York
United States Pfizer Investigational Site Monroe North Carolina
United States Pfizer Investigational Site Monroe North Carolina
United States Pfizer Investigational Site Mount Pleasant South Carolina
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site Norfolk Virginia
United States Pfizer Investigational Site Norfolk Virginia
United States Pfizer Investigational Site Oakland California
United States Pfizer Investigational Site Orlando Florida
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Pensacola Florida
United States Pfizer Investigational Site Perrysburg Ohio
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Pico Rivera California
United States Pfizer Investigational Site Randallstown Maryland
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Rockville Maryland
United States Pfizer Investigational Site Saint Louis Missouri
United States Pfizer Investigational Site Saint Louis Missouri
United States Pfizer Investigational Site Saint Louis Missouri
United States Pfizer Investigational Site Savannah Georgia
United States Pfizer Investigational Site Shreveport Louisiana
United States Pfizer Investigational Site Shreveport Louisiana
United States Pfizer Investigational Site Simpsonville South Carolina
United States Pfizer Investigational Site South Bound Brook New Jersey
United States Pfizer Investigational Site Vero Beach Florida
United States Pfizer Investigational Site Virginia Beach Virginia
United States Pfizer Investigational Site Virginia Beach Virginia
United States Pfizer Investigational Site Voorhees New Jersey
United States Pfizer Investigational Site Washington District of Columbia
United States Pfizer Investigational Site Washington District of Columbia
United States Pfizer Investigational Site Wellesley Hills Massachusetts
United States Pfizer Investigational Site Westminster Maryland
United States Pfizer Investigational Site Winston-Salem North Carolina
United States Pfizer Investigational Site Winston-Salem North Carolina
United States Pfizer Investigational Site Woodbury New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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