HypertensionPhase 3GEMINI-AALANCT00143234
Amlodipine/Atorvastatin Combination to Reduce the Health Risk of High Blood Pressure and High Cholesterol Levels
A Phase 3 study testing Amlodipine/atorvastatin single pill in people with Hypertension and Hyperlipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 118 sites in 28 countries.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Hyperlipidemia
- What is being tested?
- Amlodipine/atorvastatin single pill
- Type of treatment
- Pill or oral medicine
- How many people
- 1,825 participants
- Where
- 118 sitesin 28 countries
- Study dates
- May 2004to Jul 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of both elevated blood pressure and low density lipoprotein cholesterol levels, requiring medication
Who cannot join
- 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
Trial locations and contacts
118 sites in 28 countries.
118 sites in 28 countries
South Africa10 sites
Pfizer Investigational Site
Arcadia, Pretoria, Gauteng, 0083
Pfizer Investigational Site
Cape Town, 7129
Pfizer Investigational Site
Cape Town, 7405
Pfizer Investigational Site
Cape Town
Pfizer Investigational Site
Chatsworth, KwaZulu-Natal, 4092
Pfizer Investigational Site
Gauteng, 2059
Pfizer Investigational Site
Kwa-Zulu Natal, KwaZulu-Natal
Pfizer Investigational Site
Midrand, Johannesburg, Gauteng, 1685
Pfizer Investigational Site
Sunnyside, Pretoria, Gauteng, 0002
Pfizer Investigational Site
Worcester, Cape Province
South Korea10 sites
Pfizer Investigational Site
Anyang-si, Gyeonggi-do, 431-070
Pfizer Investigational Site
Donggu, Kwangji, 501-757
Pfizer Investigational Site
Gangnam-gu, Seoul, 135-710
Pfizer Investigational Site
Guri-si, Gyeonggi-do, 471-701
Pfizer Investigational Site
Jung-gu, Daegu, 700-721
Pfizer Investigational Site
Seo-gu, Busan, 602-739
Pfizer Investigational Site
Seoul, 110-799
Pfizer Investigational Site
Seoul, 136-705
Pfizer Investigational Site
Seoul, 152-703
Pfizer Investigational Site
Yongdeungpo-gu, Seoul, 150-713
Brazil9 sites
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, 30110-060
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, 30130-110
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, 30150-221
Pfizer Investigational Site
Botucatu, São Paulo, 18618-000
Pfizer Investigational Site
Campinas, São Paulo, 13012-000
Pfizer Investigational Site
Recife, Pernambuco, 50670-901
Pfizer Investigational Site
Ribeirão Preto, São Paulo, 14048-900
Pfizer Investigational Site
São Paulo, São Paulo, 04038-002
Pfizer Investigational Site
São Paulo, São Paulo, 01244-030
India9 sites
Pfizer Investigational Site
Bangalore, Karnataka, 562158
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 001
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 033
Pfizer Investigational Site
Mumbai, Maharashtra, 400 007
Pfizer Investigational Site
Mumbai, Nagpada Junction, 400 008
Pfizer Investigational Site
New Delhi, 100 025
Pfizer Investigational Site
New Delhi, 110 026
Pfizer Investigational Site
New Delhi, 11050
Pfizer Investigational Site
Pune, Maharashtra, 411 001
Turkey (Türkiye)9 sites
Pfizer Investigational Site
Adana, 01330
Pfizer Investigational Site
Alsancak, İzmir
Pfizer Investigational Site
Antalya, 07059
Pfizer Investigational Site
Cebeci, Ankara, 06100
Pfizer Investigational Site
Diyarbakır, 21280
Pfizer Investigational Site
Haydarpaşa, Istanbul, 81010
Pfizer Investigational Site
Istanbul
Pfizer Investigational Site
Sihhiye, Ankara, 06100
Pfizer Investigational Site
Talas, Kayseri, 38039
Australia7 sites
Pfizer Investigational Site
Fremantle, Western Australia, 6160
Pfizer Investigational Site
Heidelberg, Victoria, 3084
Pfizer Investigational Site
Melbourne, Victoria, 3004
Pfizer Investigational Site
Prahran, Victoria, 3181
Pfizer Investigational Site
Southport, Queensland, 4215
Pfizer Investigational Site
St Leonards, New South Wales, 2065
Pfizer Investigational Site
Woolloongabba, Queensland, 4102
Mexico6 sites
Pfizer Investigational Site
Aguascalientes, C.P. 20230
Pfizer Investigational Site
Metepec, 52140
Pfizer Investigational Site
México, D.F, 14000
Pfizer Investigational Site
México, 14000
Pfizer Investigational Site
Puebla City, 72000
Pfizer Investigational Site
San Luis Potosí City, 78210
Philippines6 sites
Pfizer Investigational Site
Filinvest, Alabang
Pfizer Investigational Site
Manila
Pfizer Investigational Site
Phippine General Hospital, Taft Avenue, Manila City, Manila
Pfizer Investigational Site
Quezon City, 1100
Pfizer Investigational Site
Quezon City
Pfizer Investigational Site
San Juan City, National Capital Region
Taiwan6 sites
Pfizer Investigational Site
Changhua, 500
Pfizer Investigational Site
Guei-Shan Shiang, Tau-Yuan Shian, 333
Pfizer Investigational Site
Niao-Sung Hsiang, Kaohsiung, 833
Pfizer Investigational Site
Taipei, 100
Pfizer Investigational Site
Taipei, 112
Pfizer Investigational Site
Taipei, 114
Argentina5 sites
Pfizer Investigational Site
Buenos Aires, C1181ACH
Pfizer Investigational Site
Buenos Aires, C1425ASS
Pfizer Investigational Site
Buenos Aires, C1428DCO
Pfizer Investigational Site
Buenos Aires, C1431FWO
Pfizer Investigational Site
Buenos Aires, C1437JCP
Israel5 sites
Pfizer Investigational Site
Jerusalem, 91120
Pfizer Investigational Site
Jerusalem, 91240
Pfizer Investigational Site
Rehovot, 76100
Pfizer Investigational Site
Tel Aviv, 64239
Pfizer Investigational Site
Tel HaShomer, 52621
Malaysia5 sites
Pfizer Investigational Site
Kuala Lumpur, 50586
Pfizer Investigational Site
Kuala Lumpur, 59100
Pfizer Investigational Site
Kubang Kerian, Kelantan, 16150
Pfizer Investigational Site
Kuching, Sarawak
Pfizer Investigational Site
Seremban, Negeri Sembilan, 70400
Pakistan4 sites
Pfizer Investigational Site
Faisalabad, Punjab Province
Pfizer Investigational Site
Islamabad, Punjab Province
Pfizer Investigational Site
Lahore, Punjab Province
Pfizer Investigational Site
Peshawar, Khyber Pakhtunkhwa
Indonesia3 sites
Pfizer Investigational Site
Jakarta, 10430
Pfizer Investigational Site
Jakarta, 11420
Pfizer Investigational Site
Surabaya, 60286
Saudi Arabia3 sites
Pfizer Investigational Site
Khobar
Pfizer Investigational Site
Riyadh, 11426
Pfizer Investigational Site
Riyadh, 11461
Thailand3 sites
Pfizer Investigational Site
Bangkok, 10400
Pfizer Investigational Site
Chiang Mai, 50200
Pfizer Investigational Site
KHET Rajathevee, Bangkok, 10400
United Arab Emirates3 sites
Pfizer Investigational Site
Abu Dhabi
Pfizer Investigational Site
Dubai
Pfizer Investigational Site
Sharjah city
Chile2 sites
Pfizer Investigational Site
Santiago, Región Metropolitana
Pfizer Investigational Site
Santiago, RM
Hong Kong2 sites
Pfizer Investigational Site
Pokfulam Road
Pfizer Investigational Site
Sai Ying Pun
Jordan2 sites
Pfizer Investigational Site
Amman, 11942
Pfizer Investigational Site
Amman
Singapore2 sites
Pfizer Investigational Site
Singapore, 119074
Pfizer Investigational Site
Singapore, 168752
Location not given1 site
Pfizer Investigational Site
About this study
Official title: Clinical Utility of Amlodipine/Atorvastatin to Improve Concomitant Cardiovascular Risk Factors of Hypertension and Dyslipidemia
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
- Conditions
- Hypertension, Hyperlipidemia
- Being tested
- Amlodipine/atorvastatin single pill
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine/atorvastatin single pillDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startMay 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,825 participants
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143234
- Sponsor's protocol ID
- A3841024
- Acronym
- GEMINI-AALA
- Status last verified
- Jan 2021
- First submitted
- 31 Aug 2005
- Last updated
- 27 Jan 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Amlodipine/Atorvastatin to Improve Concomitant Cardiovascular Risk Factors of Hypertension and Dyslipidemia
- ClinicalTrials.gov ID
- NCT00143234
- Acronym / sponsor ID
- GEMINI-AALA / A3841024
- Conditions
- Hypertension, Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,825 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- May 2004
- Study completion
- Jul 2005
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of both elevated blood pressure and low density lipoprotein cholesterol levels, requiring medication
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amlodipine/atorvastatin single pill | Drug | – |
Primary outcome
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
118 sites in 28 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amlodipine/atorvastatin single pill in people with Hypertension and Hyperlipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 118 sites in 28 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 118 sites in South Africa, South Korea, Brazil, India, Turkey (Türkiye) and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.