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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
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Scientific title
Clinical Utility of Amlodipine/Atorvastatin to Improve Concomitant Cardiovascular Risk Factors of Hypertension and Dyslipidemia
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Secondary ID [1]
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A3841024
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Universal Trial Number (UTN)
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Trial acronym
GEMINI-AALA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypertension
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Hyperlipidemia
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Condition category
Condition code
Cardiovascular
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Hypertension
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Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Amlodipine/atorvastatin single pill
Treatment: Drugs: Amlodipine/atorvastatin single pill
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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)
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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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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Assessment method [1]
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Timepoint [1]
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Eligibility
Key inclusion criteria
- Clinical diagnosis of both elevated blood pressure and low density lipoprotein
cholesterol levels, requiring medication
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Pfizer Investigational Site - St. Leonards
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Recruitment hospital [2]
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Pfizer Investigational Site - Southport
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Recruitment hospital [3]
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Pfizer Investigational Site - Woolloongabba
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Recruitment hospital [4]
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Pfizer Investigational Site - Heidelberg
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Recruitment hospital [5]
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Pfizer Investigational Site - Melbourne
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Recruitment hospital [6]
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Pfizer Investigational Site - Prahran
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Recruitment hospital [7]
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Pfizer Investigational Site - Fremantle
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Recruitment postcode(s) [1]
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2065 - St. Leonards
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Recruitment postcode(s) [2]
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4215 - Southport
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment postcode(s) [6]
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3181 - Prahran
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Recruitment postcode(s) [7]
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6160 - Fremantle
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Recruitment outside Australia
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Argentina
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Buenos Aires
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Brazil
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MG
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Brazil
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PE
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Brazil
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SP
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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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New Delhi
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Indonesia
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Jakarta
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Indonesia
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Rehovot
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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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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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Istanbul
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Izmir
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Kayseri
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Adana
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United Arab Emirates
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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Address
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Country
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Ethics approval
Ethics application status
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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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00143234
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Phone
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00143234
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