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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00143234




Registration number
NCT00143234
Ethics application status
Date submitted
31/08/2005
Date registered
2/09/2005
Date last updated
27/01/2021

Titles & IDs
Public title
Amlodipine/Atorvastatin Combination to Reduce the Health Risk of High Blood Pressure and High Cholesterol Levels
Scientific title
Clinical Utility of Amlodipine/Atorvastatin to Improve Concomitant Cardiovascular Risk Factors of Hypertension and Dyslipidemia
Secondary ID [1] 0 0
A3841024
Universal Trial Number (UTN)
Trial acronym
GEMINI-AALA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Hyperlipidemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Amlodipine/atorvastatin single pill

Treatment: Drugs: Amlodipine/atorvastatin single pill
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Clinical diagnosis of both elevated blood pressure and low density lipoprotein
cholesterol levels, requiring medication
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - St. Leonards
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Southport
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Woolloongabba
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Heidelberg
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Melbourne
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Prahran
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Fremantle
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
3181 - Prahran
Recruitment postcode(s) [7] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
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Brazil
State/province [2] 0 0
MG
Country [3] 0 0
Brazil
State/province [3] 0 0
PE
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Brazil
State/province [4] 0 0
SP
Country [5] 0 0
Chile
State/province [5] 0 0
Región Metropolitana
Country [6] 0 0
Chile
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RM
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Guatemala
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Guatemala
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Hong Kong
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Pokfulam Road
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Hong Kong
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Sai ying Pun
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India
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Andhra Pradesh
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India
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Karnataka
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India
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Maharashtra
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India
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Nagpada Junction
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India
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New Delhi
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Indonesia
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Jakarta
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Indonesia
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Surabaya
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Israel
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Jerusalem
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Israel
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Rehovot
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Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Jordan
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Amman
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Kwangji
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Korea, Republic of
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Kyungki-do
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Korea, Republic of
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Seoul
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Kuwait
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Sasat
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Lebanon
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Beirut
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Malaysia
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Kelantan
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Malaysia
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Negeri Sembilan
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Malaysia
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Sarawak
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Malaysia
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Kuala Lumpur
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Mexico
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D.F
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Mexico
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Aguascalientes
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Metepec
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Mexico
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Mexico
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Puebla
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San Luis Potosi
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Morocco
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Casablanca
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Punjab
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Peru
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Lima
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Metro Manila
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Philippines
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Taft Avenue, Manila City
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Philippines
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Filinvest, Alabang
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Manila
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Philippines
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Quezon City
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Saudi Arabia
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Al-Khobar
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Saudi Arabia
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Riyadh
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Singapore
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Singapore
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Cape Province
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South Africa
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Gauteng
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Natal
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South Africa
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Cape Town
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South Africa
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Kwa-Zulu Natal
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Taiwan
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Kaohsiung
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Taiwan
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Tau-Yuan Shian
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Taiwan
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Changhua City
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Taiwan
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Taipei
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Tunisia
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Tunis
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Ankara
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Istanbul
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Izmir
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Kayseri
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Adana
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Antalya
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Diyarbakir
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United Arab Emirates
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Abu Dhabi
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United Arab Emirates
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Dubai
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United Arab Emirates
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Sharjah
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00143234
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries