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

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1825

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

        • Pfizer Investigational Site
  • Argentina
      • Buenos Aires, Argentina, C1428DCO
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1431FWO
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1181ACH
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1425ASS
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1437JCP
        • Pfizer Investigational Site
  • Australia
    • New South Wales
      • St. Leonards, New South Wales, Australia, 2065
        • Pfizer Investigational Site
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Pfizer Investigational Site
      • Woolloongabba, Queensland, Australia, 4102
        • Pfizer Investigational Site
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Pfizer Investigational Site
      • Melbourne, Victoria, Australia, 3004
        • Pfizer Investigational Site
      • Prahran, Victoria, Australia, 3181
        • Pfizer Investigational Site
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Pfizer Investigational Site
  • Brazil
    • MG
      • Belo Horizonte, MG, Brazil, 30150-221
        • Pfizer Investigational Site
      • Belo Horizonte, MG, Brazil, 30110-060
        • Pfizer Investigational Site
      • Belo Horizonte, MG, Brazil, 30130-110
        • Pfizer Investigational Site
    • PE
      • Recife, PE, Brazil, 50670-901
        • Pfizer Investigational Site
    • SP
      • Botucatu, SP, Brazil, 18618-000
        • Pfizer Investigational Site
      • Campinas, SP, Brazil, 13012-000
        • Pfizer Investigational Site
      • Ribeirao Preto, SP, Brazil, 14048-900
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brazil, 01244-030
        • Pfizer Investigational Site
      • São Paulo, SP, Brazil, 04038-002
        • Pfizer Investigational Site
  • Chile
    • RM
      • Santiago, RM, Chile
        • Pfizer Investigational Site
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile
        • Pfizer Investigational Site
  • Guatemala
      • Guatemala, Guatemala, 01015
        • Pfizer Investigational Site
  • Hong Kong
      • Pokfulam Road, Hong Kong
        • Pfizer Investigational Site
      • Sai ying Pun, Hong Kong
        • Pfizer Investigational Site
  • India
      • New Delhi, India, 100 025
        • Pfizer Investigational Site
      • New Delhi, India, 110 026
        • Pfizer Investigational Site
      • New Delhi, India, 11050
        • Pfizer Investigational Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 001
        • Pfizer Investigational Site
      • Hyderabad, Andhra Pradesh, India, 500 033
        • Pfizer Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 562158
        • Pfizer Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 007
        • Pfizer Investigational Site
      • Pune, Maharashtra, India, 411 001
        • Pfizer Investigational Site
    • Nagpada Junction
      • Mumbai, Nagpada Junction, India, 400 008
        • Pfizer Investigational Site
  • Indonesia
      • Jakarta, Indonesia, 10430
        • Pfizer Investigational Site
      • Jakarta, Indonesia, 11420
        • Pfizer Investigational Site
      • Surabaya, Indonesia, 60286
        • Pfizer Investigational Site
  • Israel
      • Jerusalem, Israel, 91120
        • Pfizer Investigational Site
      • Jerusalem, Israel, 91240
        • Pfizer Investigational Site
      • Rehovot, Israel, 76100
        • Pfizer Investigational Site
      • Tel Aviv, Israel, 64239
        • Pfizer Investigational Site
      • Tel Hashomer, Israel, 52621
        • Pfizer Investigational Site
  • Jordan
      • Amman, Jordan
        • Pfizer Investigational Site
      • Amman, Jordan, 11942
        • Pfizer Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 152-703
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 136-705
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 110-799
        • Pfizer Investigational Site
    • Busan
      • Seo-gu, Busan, Korea, Republic of, 602-739
        • Pfizer Investigational Site
    • Daegu
      • Jung-gu, Daegu, Korea, Republic of, 700-721
        • Pfizer Investigational Site
    • Kwangji
      • Dong-gu, Kwangji, Korea, Republic of, 501-757
        • Pfizer Investigational Site
    • Kyungki-do
      • Anyang-city, Kyungki-do, Korea, Republic of, 431-070
        • Pfizer Investigational Site
      • Guri-City, Kyungki-do, Korea, Republic of, 471-701
        • Pfizer Investigational Site
    • Seoul
      • Gangnam-gu, Seoul, Korea, Republic of, 135-710
        • Pfizer Investigational Site
      • Yongdeungpo-gu, Seoul, Korea, Republic of, 150-713
        • Pfizer Investigational Site
  • Kuwait
      • Sasat, Kuwait, Zip Code 13110
        • Pfizer Investigational Site
  • Lebanon
      • Beirut, Lebanon
        • Pfizer Investigational Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Pfizer Investigational Site
      • Kuala Lumpur, Malaysia, 59100
        • Pfizer Investigational Site
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • Pfizer Investigational Site
    • Negeri Sembilan
      • Seremban, Negeri Sembilan, Malaysia, 70400
        • Pfizer Investigational Site
    • Sarawak
      • Kuching, Sarawak, Malaysia
        • Pfizer Investigational Site
  • Mexico
      • Aguascalientes, Mexico, C.P. 20230
        • Pfizer Investigational Site
      • Metepec, Mexico, 52140
        • Pfizer Investigational Site
      • Mexico, Mexico, 14000
        • Pfizer Investigational Site
      • Puebla, Mexico, 72000
        • Pfizer Investigational Site
      • San Luis Potosi, Mexico, 78210
        • Pfizer Investigational Site
    • D.F
      • Mexico, D.F, Mexico, 14000
        • Pfizer Investigational Site
  • Morocco
      • Casablanca, Morocco, 20000
        • Pfizer Investigational Site
  • Pakistan
    • N.w.f.p.
      • Peshawar, N.w.f.p., Pakistan
        • Pfizer Investigational Site
    • Punjab
      • Faisalabad, Punjab, Pakistan
        • Pfizer Investigational Site
      • Islamabad, Punjab, Pakistan
        • Pfizer Investigational Site
      • Lahore, Punjab, Pakistan
        • Pfizer Investigational Site
  • Peru
      • Lima, Peru, L27
        • Pfizer Investigational Site
  • Philippines
      • Filinvest, Alabang, Philippines
        • Pfizer Investigational Site
      • Manila, Philippines
        • Pfizer Investigational Site
      • Quezon City, Philippines, 1100
        • Pfizer Investigational Site
      • Quezon City, Philippines
        • Pfizer Investigational Site
    • Metro Manila
      • San Juan, Metro Manila, Philippines
        • Pfizer Investigational Site
    • Taft Avenue, Manila City
      • Phippine General Hospital, Taft Avenue, Manila City, Philippines, Manila
        • Pfizer Investigational Site
  • Saudi Arabia
      • Al-Khobar, Saudi Arabia
        • Pfizer Investigational Site
      • Riyadh, Saudi Arabia, 11426
        • Pfizer Investigational Site
      • Riyadh, Saudi Arabia, 11461
        • Pfizer Investigational Site
  • Singapore
      • Singapore, Singapore, 119074
        • Pfizer Investigational Site
      • Singapore, Singapore, 168752
        • Pfizer Investigational Site
  • South Africa
      • Cape Town, South Africa, 7405
        • Pfizer Investigational Site
      • Cape Town, South Africa
        • Pfizer Investigational Site
      • Cape Town, South Africa, 7129
        • Pfizer Investigational Site
      • Gauteng, South Africa, 2059
        • Pfizer Investigational Site
      • Kwa-Zulu Natal, South Africa
        • Pfizer Investigational Site
    • Cape Province
      • Worcester, Cape Province, South Africa
        • Pfizer Investigational Site
    • Gauteng
      • Arcadia, Pretoria, Gauteng, South Africa, 0083
        • Pfizer Investigational Site
      • Midrand, Johannesburg, Gauteng, South Africa, 1685
        • Pfizer Investigational Site
      • Sunnyside, Pretoria, Gauteng, South Africa, 0002
        • Pfizer Investigational Site
    • Natal
      • Chatsworth, Natal, South Africa, 4092
        • Pfizer Investigational Site
  • Taiwan
      • Changhua City, Taiwan, 500
        • Pfizer Investigational Site
      • Taipei, Taiwan, 100
        • Pfizer Investigational Site
      • Taipei, Taiwan, 112
        • Pfizer Investigational Site
      • Taipei, Taiwan, 114
        • Pfizer Investigational Site
    • Kaohsiung
      • Niao-Sung Hsiang, Kaohsiung, Taiwan, 833
        • Pfizer Investigational Site
    • Tau-Yuan Shian
      • Guei-Shan Shiang, Tau-Yuan Shian, Taiwan, 333
        • Pfizer Investigational Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Pfizer Investigational Site
      • Chiang Mai, Thailand, 50200
        • Pfizer Investigational Site
    • Bangkok
      • KHET Rajathevee, Bangkok, Thailand, 10400
        • Pfizer Investigational Site
  • Tunisia
      • Tunis, Tunisia
        • Pfizer Investigational Site
  • Turkey
      • Adana, Turkey, 01330
        • Pfizer Investigational Site
      • Antalya, Turkey, 07059
        • Pfizer Investigational Site
      • Diyarbakir, Turkey, 21280
        • Pfizer Investigational Site
      • Istanbul, Turkey
        • Pfizer Investigational Site
    • Ankara
      • Cebeci, Ankara, Turkey, 06100
        • Pfizer Investigational Site
      • Sihhiye, Ankara, Turkey, 06100
        • Pfizer Investigational Site
    • Istanbul
      • Haydarpasa, Istanbul, Turkey, 81010
        • Pfizer Investigational Site
    • Izmir
      • Alsancak, Izmir, Turkey
        • Pfizer Investigational Site
    • Kayseri
      • Talas, Kayseri, Turkey, 38039
        • Pfizer Investigational Site
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Pfizer Investigational Site
      • Dubai, United Arab Emirates
        • Pfizer Investigational Site
      • Sharjah, United Arab Emirates
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion

July 1, 2005

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (ESTIMATE)

September 2, 2005

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3841024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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