Amlodipine/Atorvastatin Combination to Reduce the Health Risk of High Blood Pressure and High Cholesterol Levels (GEMINI-AALA)
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00143234
First received: August 31, 2005
Last updated: October 2, 2008
Last verified: October 2008
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143234
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| 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:
|
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 23, 2013