NCT00150384

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_4 hypertension

Geographic Reach
1 country

106 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

First QC Date

September 6, 2005

Last Update Submit

January 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Interventions

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African American men and women with concurrent hypertension and dyslipidemia that is either treated or untreated

You may not qualify if:

  • Subjects currently being treated with concomitant amlodipine and atorvastatin therapy, including Caduet
  • Subjects with blood pressure at goal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (106)

Pfizer Investigational Site

Birmingham, Alabama, 35209, United States

Location

Pfizer Investigational Site

Birmingham, Alabama, 35211, United States

Location

Pfizer Investigational Site

Huntsville, Alabama, 35801, United States

Location

Pfizer Investigational Site

Little Rock, Arkansas, 72204, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90024, United States

Location

Pfizer Investigational Site

Oakland, California, 94609-3425, United States

Location

Pfizer Investigational Site

Pico Rivera, California, 90660, United States

Location

Pfizer Investigational Site

Bridgeport, Connecticut, 6610, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20010, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20037, United States

Location

Pfizer Investigational Site

Aventura, Florida, 33180, United States

Location

Pfizer Investigational Site

Gainesville, Florida, 32601, United States

Location

Pfizer Investigational Site

Jacksonville, Florida, 32204, United States

Location

Pfizer Investigational Site

Orlando, Florida, 32806, United States

Location

Pfizer Investigational Site

Pensacola, Florida, 32503, United States

Location

Pfizer Investigational Site

Vero Beach, Florida, 32960, United States

Location

Pfizer Investigational Site

Athens, Georgia, 30606, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30303, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30309, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30310, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30342, United States

Location

Pfizer Investigational Site

Augusta, Georgia, 30904, United States

Location

Pfizer Investigational Site

Columbus, Georgia, 31901, United States

Location

Pfizer Investigational Site

Columbus, Georgia, 31904, United States

Location

Pfizer Investigational Site

Decatur, Georgia, 30033, United States

Location

Pfizer Investigational Site

Lincolnton, Georgia, 30817, United States

Location

Pfizer Investigational Site

Savannah, Georgia, 31406, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60616, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60637-1470, United States

Location

Pfizer Investigational Site

Maywood, Illinois, 60153, United States

Location

Pfizer Investigational Site

Merrillville, Indiana, 46410, United States

Location

Pfizer Investigational Site

Overland Park, Kansas, 66211, United States

Location

Pfizer Investigational Site

Bossier City, Louisiana, 71111, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, 70117-4817, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, 70125, United States

Location

Pfizer Investigational Site

Shreveport, Louisiana, 71101, United States

Location

Pfizer Investigational Site

Shreveport, Louisiana, 71130, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21201, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21215, United States

Location

Pfizer Investigational Site

Columbia, Maryland, 21045, United States

Location

Pfizer Investigational Site

Randallstown, Maryland, 21133, United States

Location

Pfizer Investigational Site

Rockville, Maryland, 20850, United States

Location

Pfizer Investigational Site

Westminster, Maryland, 21157, United States

Location

Pfizer Investigational Site

Brockton, Massachusetts, 02301, United States

Location

Pfizer Investigational Site

Wellesley Hills, Massachusetts, 02481-2106, United States

Location

Pfizer Investigational Site

Detroit, Michigan, 48201, United States

Location

Pfizer Investigational Site

Detroit, Michigan, 48235, United States

Location

Pfizer Investigational Site

Lansing, Michigan, 48917, United States

Location

Pfizer Investigational Site

Livonia, Michigan, 48152, United States

Location

Pfizer Investigational Site

Jackson, Mississippi, 39202, United States

Location

Pfizer Investigational Site

Jackson, Mississippi, 39216, United States

Location

Pfizer Investigational Site

Kansas City, Missouri, 64112, United States

Location

Pfizer Investigational Site

Kansas City, Missouri, 64131, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63104, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63141, United States

Location

Pfizer Investigational Site

Cherry Hill, New Jersey, 08034, United States

Location

Pfizer Investigational Site

East Orange, New Jersey, 07018, United States

Location

Pfizer Investigational Site

Elizabeth, New Jersey, 07202, United States

Location

Pfizer Investigational Site

Hammonton, New Jersey, 08037, United States

Location

Pfizer Investigational Site

South Bound Brook, New Jersey, 08880, United States

Location

Pfizer Investigational Site

Voorhees Township, New Jersey, 08043, United States

Location

Pfizer Investigational Site

Woodbury, New Jersey, 08096, United States

Location

Pfizer Investigational Site

Brooklyn, New York, 11203, United States

Location

Pfizer Investigational Site

Brooklyn, New York, United States

Location

Pfizer Investigational Site

Buffalo, New York, 14215, United States

Location

Pfizer Investigational Site

Mineola, New York, 11501, United States

Location

Pfizer Investigational Site

Charlotte, North Carolina, 28209, United States

Location

Pfizer Investigational Site

Greenville, North Carolina, 27834, United States

Location

Pfizer Investigational Site

Monroe, North Carolina, 28112, United States

Location

Pfizer Investigational Site

Monroe, North Carolina, United States

Location

Pfizer Investigational Site

Winston-Salem, North Carolina, 27103-3315, United States

Location

Pfizer Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45219, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45229, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45236, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45246, United States

Location

Pfizer Investigational Site

Dayton, Ohio, 45402, United States

Location

Pfizer Investigational Site

Dayton, Ohio, 45406, United States

Location

Pfizer Investigational Site

Maumee, Ohio, 43537, United States

Location

Pfizer Investigational Site

Perrysburg, Ohio, 43551, United States

Location

Pfizer Investigational Site

Bensalem, Pennsylvania, 19020, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19141, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19146, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19148, United States

Location

Pfizer Investigational Site

Bamberg, South Carolina, 29003, United States

Location

Pfizer Investigational Site

Charleston, South Carolina, 29425, United States

Location

Pfizer Investigational Site

Clinton, South Carolina, 29325, United States

Location

Pfizer Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

Location

Pfizer Investigational Site

Simpsonville, South Carolina, 29681, United States

Location

Pfizer Investigational Site

Bartlett, Tennessee, 38134, United States

Location

Pfizer Investigational Site

Jackson, Tennessee, 38305, United States

Location

Pfizer Investigational Site

Beaumont, Texas, 77702, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75235, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75254, United States

Location

Pfizer Investigational Site

Houston, Texas, 77024, United States

Location

Pfizer Investigational Site

Houston, Texas, 77030, United States

Location

Pfizer Investigational Site

Houston, Texas, 77054, United States

Location

Pfizer Investigational Site

Emporia, Virginia, 23847, United States

Location

Pfizer Investigational Site

Norfolk, Virginia, 23502, United States

Location

Pfizer Investigational Site

Norfolk, Virginia, 23510, United States

Location

Pfizer Investigational Site

Richmond, Virginia, 23249, United States

Location

Pfizer Investigational Site

Richmond, Virginia, 23294, United States

Location

Pfizer Investigational Site

Virginia Beach, Virginia, 23454, United States

Location

Pfizer Investigational Site

Virginia Beach, Virginia, 23455, United States

Location

Pfizer Investigational Site

Milwaukee, Wisconsin, 53209, United States

Location

MeSH Terms

Conditions

HypertensionDyslipidemias

Interventions

amlodipine, atorvastatin drug combination

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

July 1, 2004

Study Completion

August 1, 2005

Last Updated

January 27, 2021

Record last verified: 2021-01

Locations