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NCT00143234 Clinical Trial

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

Hypertension Clinical Trial

— GEMINI-AALA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00143234
Other study ID # A3841024
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 2004
Est. completion date July 2005

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 1825
Est. completion date July 2005
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Amlodipine/atorvastatin single pill

Locations
Country Name City State
Pfizer Investigational Site
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Buenos Aires
Australia Pfizer Investigational Site Fremantle Western Australia
Australia Pfizer Investigational Site Heidelberg Victoria
Australia Pfizer Investigational Site Melbourne Victoria
Australia Pfizer Investigational Site Prahran Victoria
Australia Pfizer Investigational Site Southport Queensland
Australia Pfizer Investigational Site St. Leonards New South Wales
Australia Pfizer Investigational Site Woolloongabba Queensland
Brazil Pfizer Investigational Site Belo Horizonte MG
Brazil Pfizer Investigational Site Belo Horizonte MG
Brazil Pfizer Investigational Site Belo Horizonte MG
Brazil Pfizer Investigational Site Botucatu SP
Brazil Pfizer Investigational Site Campinas SP
Brazil Pfizer Investigational Site Recife PE
Brazil Pfizer Investigational Site Ribeirao Preto SP
Brazil Pfizer Investigational Site São Paulo SP
Brazil Pfizer Investigational Site Sao Paulo SP
Chile Pfizer Investigational Site Santiago Región Metropolitana
Chile Pfizer Investigational Site Santiago RM
Guatemala Pfizer Investigational Site Guatemala
Hong Kong Pfizer Investigational Site Pokfulam Road
Hong Kong Pfizer Investigational Site Sai ying Pun
India Pfizer Investigational Site Bangalore Karnataka
India Pfizer Investigational Site Hyderabad Andhra Pradesh
India Pfizer Investigational Site Hyderabad Andhra Pradesh
India Pfizer Investigational Site Mumbai Nagpada Junction
India Pfizer Investigational Site Mumbai Maharashtra
India Pfizer Investigational Site New Delhi
India Pfizer Investigational Site New Delhi
India Pfizer Investigational Site New Delhi
India Pfizer Investigational Site Pune Maharashtra
Indonesia Pfizer Investigational Site Jakarta
Indonesia Pfizer Investigational Site Jakarta
Indonesia Pfizer Investigational Site Surabaya
Israel Pfizer Investigational Site Jerusalem
Israel Pfizer Investigational Site Jerusalem
Israel Pfizer Investigational Site Rehovot
Israel Pfizer Investigational Site Tel Aviv
Israel Pfizer Investigational Site Tel Hashomer
Jordan Pfizer Investigational Site Amman
Jordan Pfizer Investigational Site Amman
Korea, Republic of Pfizer Investigational Site Anyang-city Kyungki-do
Korea, Republic of Pfizer Investigational Site Dong-gu Kwangji
Korea, Republic of Pfizer Investigational Site Gangnam-gu Seoul
Korea, Republic of Pfizer Investigational Site Guri-City Kyungki-do
Korea, Republic of Pfizer Investigational Site Jung-gu Daegu
Korea, Republic of Pfizer Investigational Site Seo-gu Busan
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Yongdeungpo-gu Seoul
Kuwait Pfizer Investigational Site Sasat
Lebanon Pfizer Investigational Site Beirut
Malaysia Pfizer Investigational Site Kuala Lumpur
Malaysia Pfizer Investigational Site Kuala Lumpur
Malaysia Pfizer Investigational Site Kubang Kerian Kelantan
Malaysia Pfizer Investigational Site Kuching Sarawak
Malaysia Pfizer Investigational Site Seremban Negeri Sembilan
Mexico Pfizer Investigational Site Aguascalientes
Mexico Pfizer Investigational Site Metepec
Mexico Pfizer Investigational Site Mexico
Mexico Pfizer Investigational Site Mexico D.F
Mexico Pfizer Investigational Site Puebla
Mexico Pfizer Investigational Site San Luis Potosi
Morocco Pfizer Investigational Site Casablanca
Pakistan Pfizer Investigational Site Faisalabad Punjab
Pakistan Pfizer Investigational Site Islamabad Punjab
Pakistan Pfizer Investigational Site Lahore Punjab
Pakistan Pfizer Investigational Site Peshawar N.w.f.p.
Peru Pfizer Investigational Site Lima
Philippines Pfizer Investigational Site Filinvest, Alabang
Philippines Pfizer Investigational Site Manila
Philippines Pfizer Investigational Site Phippine General Hospital Taft Avenue, Manila City
Philippines Pfizer Investigational Site Quezon City
Philippines Pfizer Investigational Site Quezon City
Philippines Pfizer Investigational Site San Juan Metro Manila
Saudi Arabia Pfizer Investigational Site Al-Khobar
Saudi Arabia Pfizer Investigational Site Riyadh
Saudi Arabia Pfizer Investigational Site Riyadh
Singapore Pfizer Investigational Site Singapore
Singapore Pfizer Investigational Site Singapore
South Africa Pfizer Investigational Site Arcadia, Pretoria Gauteng
South Africa Pfizer Investigational Site Cape Town
South Africa Pfizer Investigational Site Cape Town
South Africa Pfizer Investigational Site Cape Town
South Africa Pfizer Investigational Site Chatsworth Natal
South Africa Pfizer Investigational Site Gauteng
South Africa Pfizer Investigational Site Kwa-Zulu Natal
South Africa Pfizer Investigational Site Midrand, Johannesburg Gauteng
South Africa Pfizer Investigational Site Sunnyside, Pretoria Gauteng
South Africa Pfizer Investigational Site Worcester Cape Province
Taiwan Pfizer Investigational Site Changhua City
Taiwan Pfizer Investigational Site Guei-Shan Shiang Tau-Yuan Shian
Taiwan Pfizer Investigational Site Niao-Sung Hsiang Kaohsiung
Taiwan Pfizer Investigational Site Taipei
Taiwan Pfizer Investigational Site Taipei
Taiwan Pfizer Investigational Site Taipei
Thailand Pfizer Investigational Site Bangkok
Thailand Pfizer Investigational Site Chiang Mai
Thailand Pfizer Investigational Site KHET Rajathevee Bangkok
Tunisia Pfizer Investigational Site Tunis
Turkey Pfizer Investigational Site Adana
Turkey Pfizer Investigational Site Alsancak Izmir
Turkey Pfizer Investigational Site Antalya
Turkey Pfizer Investigational Site Cebeci Ankara
Turkey Pfizer Investigational Site Diyarbakir
Turkey Pfizer Investigational Site Haydarpasa Istanbul
Turkey Pfizer Investigational Site Istanbul
Turkey Pfizer Investigational Site Sihhiye Ankara
Turkey Pfizer Investigational Site Talas Kayseri
United Arab Emirates Pfizer Investigational Site Abu Dhabi
United Arab Emirates Pfizer Investigational Site Dubai
United Arab Emirates Pfizer Investigational Site Sharjah

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

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, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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