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: September 6, 2005 Last Updated: 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:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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 107 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

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

Additional relevant MeSH terms:

Antimetabolites
Vasodilator Agents
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Vascular Diseases
Calcium Channel Blockers
Enzyme Inhibitors
Anticholesteremic Agents
Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Antihypertensive Agents
Pharmacologic Actions
Amlodipine
Membrane Transport Modulators
Therapeutic Uses
Cardiovascular Diseases
Dyslipidemias
Atorvastatin
Hypertension
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009