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
  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:


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
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 ClinicalTrials.gov identifier: NCT00143234

  Hide Study Locations
Locations
Argentina
Pfizer Investigational Site
Unknown, Buenos Aires, Argentina, C1221ACI
Pfizer Investigational Site
Buenos Aires, Argentina, C1437JCP
Pfizer Investigational Site
Buenos Aires, Argentina, C1181ACH
Pfizer Investigational Site
Buenos Aires, Argentina, C1425ASS
Pfizer Investigational Site
Buenos Aires, Argentina, C1428DCO
Pfizer Investigational Site
Buenos Aires, Argentina, C1431FWO
Australia, New South Wales
Pfizer Investigational Site
St. Leonards, New South Wales, Australia, 2065
Australia, Queensland
Pfizer Investigational Site
Southport, Queensland, Australia, 4215
Pfizer Investigational Site
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Pfizer Investigational Site
Heidelberg, Victoria, Australia, 3084
Pfizer Investigational Site
Melbourne, Victoria, Australia, 3004
Pfizer Investigational Site
Prahran, Victoria, Australia, 3181
Australia, Western Australia
Pfizer Investigational Site
Fremantle, Western Australia, Australia, 6160
Brazil
Pfizer Investigational Site
Belo Horizonte, MG, Brazil, 30150-221
Pfizer Investigational Site
Belo Horizonte, MG, Brazil, 30130-110
Pfizer Investigational Site
Belo Horizonte, MG, Brazil, 30110-060
Pfizer Investigational Site
Recife, PE, Brazil, 50670-901
Pfizer Investigational Site
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
Chile
Pfizer Investigational Site
Santiago, Región Metropolitana, Chile
Pfizer Investigational Site
Santiago, RM, Chile
Guatemala
Pfizer Investigational Site
Guatemala, Guatemala, 01015
Hong Kong
Pfizer Investigational Site
Pokfulam Road, Hong Kong
Pfizer Investigational Site
Sai ying Pun, Hong Kong
Pfizer Investigational Site
Unknown, Hong Kong
India
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500 033
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500 001
Pfizer Investigational Site
Bangalore, Karnataka, India, 562158
Pfizer Investigational Site
Mumbai, Maharashtra, India, 400 007
Pfizer Investigational Site
Pune, Maharashtra, India, 411 001
Pfizer Investigational Site
Mumbai, Nagpada Junction, India, 400 008
Pfizer Investigational Site
New Delhi, India, 110 026
Pfizer Investigational Site
New Delhi, India, 11050
Pfizer Investigational Site
New Delhi, India, 100 025
Indonesia
Pfizer Investigational Site
Jakarta, Indonesia, 10430
Pfizer Investigational Site
Jakarta, Indonesia, 11420
Pfizer Investigational Site
Surabaya, Indonesia, 60286
Israel
Pfizer Investigational Site
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
Jordan
Pfizer Investigational Site
Amman, Jordan, 11942
Pfizer Investigational Site
Amman, Jordan
Korea, Republic of
Pfizer Investigational Site
Seo-gu, Busan, Korea, Republic of, 602-739
Pfizer Investigational Site
Jung-gu, Daegu, Korea, Republic of, 700-721
Pfizer Investigational Site
Dong-gu, Kwangji, Korea, Republic of, 501-757
Pfizer Investigational Site
Anyang-city, Kyungki-do, Korea, Republic of, 431-070
Pfizer Investigational Site
Guri-City, Kyungki-do, Korea, Republic of, 471-701
Pfizer Investigational Site
Gangnam-gu, Seoul, Korea, Republic of, 135-710
Pfizer Investigational Site
Yongdeungpo-gu, Seoul, Korea, Republic of, 150-713
Pfizer Investigational Site
Seoul, Korea, Republic of, 136-705
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-799
Pfizer Investigational Site
Seoul, Korea, Republic of, 152-703
Kuwait
Pfizer Investigational Site
Sasat, Kuwait, Zip Code 13110
Lebanon
Pfizer Investigational Site
Beirut, Lebanon
Pfizer Investigational Site
Unknown, Lebanon
Malaysia
Pfizer Investigational Site
Kubang Kerian, Kelantan, Malaysia, 16150
Pfizer Investigational Site
Seremban, Negeri Sembilan, Malaysia, 70400
Pfizer Investigational Site
Kuching, Sarawak, Malaysia
Pfizer Investigational Site
Kuala Lumpur, Malaysia, 59100
Pfizer Investigational Site
Kuala Lumpur, Malaysia, 50586
Mexico
Pfizer Investigational Site
Mexico, D.F, Mexico, 14000
Pfizer Investigational Site
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
Morocco
Pfizer Investigational Site
Casablanca, Morocco, 20000
Pakistan
Pfizer Investigational Site
Peshawar, N.w.f.p., Pakistan
Pfizer Investigational Site
Faisalabad, Punjab, Pakistan
Pfizer Investigational Site
Islamabad, Punjab, Pakistan
Pfizer Investigational Site
Lahore, Punjab, Pakistan
Peru
Pfizer Investigational Site
Lima, Peru, L27
Philippines
Pfizer Investigational Site
San Juan, Metro Manila, Philippines
Pfizer Investigational Site
Phippine General Hospital, Taft Avenue, Manila City, Philippines, Manila
Pfizer Investigational Site
Filinvest, Alabang, Philippines
Pfizer Investigational Site
Manila, Philippines
Pfizer Investigational Site
Quezon City, Philippines, 1100
Pfizer Investigational Site
Quezon City, Philippines
Saudi Arabia
Pfizer Investigational Site
Al-Khobar, Saudi Arabia
Pfizer Investigational Site
Riyadh, Saudi Arabia, 11461
Pfizer Investigational Site
Riyadh, Saudi Arabia, 11426
Singapore
Pfizer Investigational Site
Singapore, Singapore, 168752
Pfizer Investigational Site
Singapore, Singapore, 119074
South Africa
Pfizer Investigational Site
Worcester, Cape Province, South Africa
Pfizer Investigational Site
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
4091, Kwa-Zulu Natal, South Africa
Pfizer Investigational Site
Chatsworth, Natal, South Africa, 4092
Pfizer Investigational Site
Cape Town, South Africa
Pfizer Investigational Site
Cape Town, South Africa, 7405
Pfizer Investigational Site
Cape Town, South Africa, 7129
Pfizer Investigational Site
Gauteng, South Africa, 2059
Taiwan
Pfizer Investigational Site
Niao-Sung Hsiang, Kaohsiung, Taiwan, 833
Pfizer Investigational Site
Guei-Shan Shiang, Tau-Yuan Shian, Taiwan, 333
Pfizer Investigational Site
Changhua City, Taiwan, 500
Pfizer Investigational Site
Taipei, Taiwan, 112
Pfizer Investigational Site
Taipei, Taiwan, 114
Pfizer Investigational Site
Taipei, Taiwan, 100
Thailand
Pfizer Investigational Site
Khet Rajathevee, Bangkok, Thailand, 10400
Pfizer Investigational Site
Bangkok, Thailand, 10400
Pfizer Investigational Site
Chiang Mai, Thailand, 50200
Tunisia
Pfizer Investigational Site
Tunis, Tunisia
Turkey
Pfizer Investigational Site
Cebeci, Ankara, Turkey, 06100
Pfizer Investigational Site
Sihhiye, Ankara, Turkey, 06100
Pfizer Investigational Site
Unknown, Gaziantep, Turkey
Pfizer Investigational Site
Haydarpasa, Istanbul, Turkey, 81010
Pfizer Investigational Site
Alsancak, Izmir, Turkey
Pfizer Investigational Site
Talas, Kayseri, Turkey, 38039
Pfizer Investigational Site
Adana, Turkey, 01330
Pfizer Investigational Site
Antalya, Turkey, 07059
Pfizer Investigational Site
Diyarbakir, Turkey, 21280
Pfizer Investigational Site
Istanbul, Turkey
United Arab Emirates
Pfizer Investigational Site
Abu Dhabi, United Arab Emirates
Pfizer Investigational Site
Dubai, United Arab Emirates
Pfizer Investigational Site
Sharjah, United Arab Emirates
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:
Hypertension
Hyperlipidemias
Vascular Diseases
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine, atorvastatin drug combination
Amlodipine
Atorvastatin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014