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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: August 31, 2005
Last updated: April 21, 2015
Last verified: April 2015
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
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:

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00143234

  Show 121 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

No publications provided Identifier: NCT00143234     History of Changes
Other Study ID Numbers: A3841024
Study First Received: August 31, 2005
Last Updated: April 21, 2015
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Amlodipine, atorvastatin drug combination
Anticholesteremic Agents
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents processed this record on November 27, 2015