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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00143234
First received: August 31, 2005
Last updated: October 2, 2008
Last verified: October 2008
History of Changes
  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 3

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 Amlodipine/Atorvastatin to Improve Concomitant Cardiovascular Risk Factors of Hypertension and Dyslipidemia

Resource links provided by NLM:

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 121 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

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

Additional relevant MeSH terms:
Hyperlipidemias
Hypertension
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular 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 May 22, 2013