Comparing Amlodipine/Atorvastatin Co-Administration To Amlodipine Alone In Patients With Hypertension And Dyslipidemia

This study has been completed.

First Received: September 9, 2005 Last Updated: February 20, 2007 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00174330

Purpose

To evaluate efficacy of the dual therapy of atorvastatin + amlodipine vs. amlodipine alone .

Condition	Intervention	Phase
Hypertension Hyperlipidemia	Drug: atorvastatin Drug: amlodipine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Randomized, Open-Label Study To Evaluate Efficacy And Safety Of Dual Therapy With Atorvastatin Plus Amlodipine When Compared Amlodipine Therapy Alone In The Treatment Of Subjects With Concurrent Hyperlipidemia And Hypertension.

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

To evaluate efficacy of the dual therapy of atorvastatin 10mg or 20mg + amlodipine 5mg or 10mg vs. amlodipine 5mg or 10mg alone

Secondary Outcome Measures:

To provide comparative evaluation of the safety profile of the dual therapy with atorvastatin + amlodipine versus amlodipine alone.

Estimated Enrollment:	330
Study Start Date:	May 2005
Estimated Study Completion Date:	February 2006

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with a diagnosis of both hyperlipidemia and hypertension.

Exclusion Criteria:

Subjects with Type 1 diabetes mellitus or Type 2 diabetes mellitus.
Subjects with other atherosclerotic disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174330

Locations

China
Pfizer Investigational Site
Shanghai, China, 200025
Pfizer Investigational Site
Shanghai, China, 200003
Pfizer Investigational Site
Shanghai, China, 200233
Pfizer Investigational Site
Tianjin, China, 300211
Pfizer Investigational Site
Beijing, China, 100083
Pfizer Investigational Site
Beijing, China, 100029
Pfizer Investigational Site
Beijing, China
Pfizer Investigational Site
Shanghai, China, 200032
China, BEIJING
Pfizer Investigational Site
Beijing, BEIJING, China, 100044
China, Guangdong
Pfizer Investigational Site
Guangzhou, Guangdong, China, 510080
Pfizer Investigational Site
Guangzhou, Guangdong, China, 510515
Pfizer Investigational Site
Guangzhou, Guangdong, China, 510100
China, Jiangsu
Pfizer Investigational Site
Nanjing, Jiangsu, China, 210029
China, Liaoning Province
Pfizer Investigational Site
Shen Yang, Liaoning Province, China, 110016
China, Zhejiang
Pfizer Investigational Site
Hangzhou, Zhejiang, China, 310016

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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

No publications provided

Study ID Numbers:	A3841026
Study First Received:	September 9, 2005
Last Updated:	February 20, 2007
ClinicalTrials.gov Identifier:	NCT00174330 History of Changes
Health Authority:	China: State Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Vasodilator Agents
Hyperlipidemias
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 February 08, 2010