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

Primary Purpose

Hypertension, Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Amlodipine/atorvastatin single pill
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
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Outcomes

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

Full Information

First Posted
August 31, 2005
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00143234
Brief Title
Amlodipine/Atorvastatin Combination to Reduce the Health Risk of High Blood Pressure and High Cholesterol Levels
Acronym
GEMINI-AALA
Official Title
Clinical Utility of Amlodipine/Atorvastatin to Improve Concomitant Cardiovascular Risk Factors of Hypertension and Dyslipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1825 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Amlodipine/atorvastatin single pill
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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