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

Tracking Information

First Received Date ^ICMJE

August 31, 2005

Last Updated Date

October 2, 2008

Start Date ^ICMJE

May 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

To evaluate the efficacy of amlodipine/atorvastatin therapy by assessing the percentage of intent-to-treat subjects achieving both blood pressure and lipid treatment goals as defined by Joint National Committee (JNC) Guidelines (Report VII) and National

Change History

Complete list of historical versions of study NCT00143234 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

To assess changes from baseline in LDL-C, total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), HDL C/LDL C ratio, SBP and DBP after 14 weeks of open-label treatment. To assess the percentage of intent-to-treat subjects achie

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension
Hyperlipidemia

Intervention ^ICMJE

Drug: Amlodipine/atorvastatin single pill

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1825

Completion Date

July 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Argentina, Australia, Brazil, Chile, Guatemala, Hong Kong, India, Indonesia, Israel, Jordan, Korea, Republic of, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Pakistan, Peru, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates

Administrative Information

NCT Number ^ICMJE

NCT00143234

Other Study ID Numbers ^ICMJE

A3841024

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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