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

Phase 4CompletedNCT00150384

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.500 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Hypertension Dyslipidemia

Interventions

Amlodipine/AtorvastatinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (106)

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Birmingham, Alabama, United States

Pfizer Investigational Site

Birmingham, Alabama, United States

Pfizer Investigational Site

Huntsville, Alabama, United States

Pfizer Investigational Site

Little Rock, Arkansas, United States

Pfizer Investigational Site

Los Angeles, California, United States

Pfizer Investigational Site

Oakland, California, United States

Pfizer Investigational Site

Pico Rivera, California, United States

Pfizer Investigational Site

Bridgeport, Connecticut, United States

Pfizer Investigational Site

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

Pfizer Investigational Site

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

...and 96 more locations