Amlodipine/Atorvastatin Combination to Reduce the Health Risk of High Blood Pressure and High Cholesterol Levels - Full Text View

Amlodipine/Atorvastatin Combination to Reduce the Health Risk of High Blood Pressure and High Cholesterol Levels (GEMINI-AALA)

This study has been completed.

First Received: August 31, 2005 Last Updated: October 2, 2008 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00143234

Purpose

The purpose of the study is to measure the effect of the amlodipine/atorvastatin combination pill in reducing both elevated blood pressure and cholesterol levels to levels suggested by guidelines

Condition	Intervention	Phase
Hypertension Hyperlipidemia	Drug: Amlodipine/atorvastatin single pill	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Clinical Utility of Amlodipine/Atorvastatin to Improve Concomitant Cardiovascular Risk Factors of Hypertension and Dyslipidemia

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol 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 the efficacy of amlodipine/atorvastatin 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 changes from baseline in lipid profile and systolic and diastolic BP after 14 weeks treatment; and in this secondary and the primary objectives stratified by prior BP and lipid therapy, and in diabetic subjects; safety

Estimated Enrollment:	1825
Study Start Date:	May 2004
Estimated Study Completion Date:	July 2005

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of both elevated blood pressure and low density lipoprotein cholesterol levels, requiring medication

Exclusion Criteria:

Patients with blood pressure adequately maintained at goal with or without medication
Patients currently treated with both amlodipine and atorvastatin or not at blood pressure or lipid level while taking the highest dose of amlodipine or atorvastatin, respectively

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143234

Show 124 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:	A3841024
Study First Received:	August 31, 2005
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00143234 History of Changes
Health Authority:	Taiwan: Department of Health

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 November 27, 2009