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

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

April 17, 2007

Start Date ^ICMJE

July 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

To evaluate the efficacy of Caduet therapy by assessing the percentage of intent-to-treat subjects achieving both BP and lipid treatment goals as defined by the Joint National Committee (JNC) Guidelines (Report 7) and National Cholesterol Education Progr

Change History

Complete list of historical versions of study NCT00150384 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

To assess the percentage of subjects achieving treatment goals as defined by the JNC 7 Guidelines stratified by the final dose of amlodipine.To assess the percentage of subjects achieving treatment goals as defined by the NCEP guidelines stratified by th

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hypertension
Dyslipidemia

Intervention ^ICMJE

Drug: Amlodipine/Atorvastatin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

500

Completion Date

August 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00150384

Responsible Party

Study ID Numbers ^ICMJE

A3841025

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP