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

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

This study has been completed.

First Received on September 6, 2005. Last Updated on April 17, 2007 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00150384

Purpose

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

Condition	Intervention	Phase
Hypertension Dyslipidemia	Drug: Amlodipine/Atorvastatin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Clinical Utility Of Caduet In Simultaneously Achieving Blood Pressure And Lipid Endpoints In A Specific Patient Population (CAPABLE)

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Lipids Amlodipine Amlodipine besylate Atorvastatin Atorvastatin calcium Caduet

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 Measures:

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

Estimated Enrollment:	500
Study Start Date:	July 2004
Estimated Study Completion Date:	August 2005

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150384

Show 106 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00150384 History of Changes
Other Study ID Numbers:	A3841025
Study First Received:	September 6, 2005
Last Updated:	April 17, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypertension
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine
Amlodipine, atorvastatin drug combination
Atorvastatin
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on February 09, 2012