CClinicalTrials.gg
CompletedNCT00143234GEMINI-AALAUpdated Jan 27, 2021

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

A Phase 3 interventional study of Amlodipine/atorvastatin single pill in Hypertension and Hyperlipidemia, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 118 sites in 27 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-27.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,825
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

02

Conditions studied

  • Hypertension
  • Hyperlipidemia
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 1,825 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical diagnosis of both elevated blood pressure and low density lipoprotein cholesterol levels, requiring medication

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
1,825 participants

Interventions

  • DrugAmlodipine/atorvastatin single pill
06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

118 sites
  • Pfizer Investigational Site
    Buenos Aires, C1181ACH, Argentina
  • Pfizer Investigational Site
    Buenos Aires, C1425ASS, Argentina
  • Pfizer Investigational Site
    Buenos Aires, C1428DCO, Argentina
  • Pfizer Investigational Site
    Buenos Aires, C1431FWO, Argentina
  • Pfizer Investigational Site
    Buenos Aires, C1437JCP, Argentina
  • Pfizer Investigational Site
    St. Leonards, New South Wales 2065, Australia
  • Pfizer Investigational Site
    Southport, Queensland 4215, Australia
  • Pfizer Investigational Site
    Woolloongabba, Queensland 4102, Australia
  • Pfizer Investigational Site
    Heidelberg, Victoria 3084, Australia
  • Pfizer Investigational Site
    Melbourne, Victoria 3004, Australia
  • Pfizer Investigational Site
    Prahran, Victoria 3181, Australia
  • Pfizer Investigational Site
    Fremantle, Western Australia 6160, Australia
  • Pfizer Investigational Site
    Belo Horizonte, MG 30110-060, Brazil
  • Pfizer Investigational Site
    Belo Horizonte, MG 30130-110, Brazil
  • Pfizer Investigational Site
    Belo Horizonte, MG 30150-221, Brazil
  • Pfizer Investigational Site
    Recife, PE 50670-901, Brazil
  • Pfizer Investigational Site
    Botucatu, SP 18618-000, Brazil
  • Pfizer Investigational Site
    Campinas, SP 13012-000, Brazil
  • Pfizer Investigational Site
    Ribeirao Preto, SP 14048-900, Brazil
  • Pfizer Investigational Site
    Sao Paulo, SP 01244-030, Brazil
  • Pfizer Investigational Site
    São Paulo, SP 04038-002, Brazil
  • Pfizer Investigational Site
    Santiago, Región Metropolitana, Chile
  • Pfizer Investigational Site
    Santiago, RM, Chile
  • Pfizer Investigational Site
    Guatemala, 01015, Guatemala
  • Pfizer Investigational Site
    Pokfulam Road, Hong Kong
  • Pfizer Investigational Site
    Sai ying Pun, Hong Kong
  • Pfizer Investigational Site
    Hyderabad, Andhra Pradesh 500 001, India
  • Pfizer Investigational Site
    Hyderabad, Andhra Pradesh 500 033, India
  • Pfizer Investigational Site
    Bangalore, Karnataka 562158, India
  • Pfizer Investigational Site
    Mumbai, Maharashtra 400 007, India
  • Pfizer Investigational Site
    Pune, Maharashtra 411 001, India
  • Pfizer Investigational Site
    Mumbai, Nagpada Junction 400 008, India
  • Pfizer Investigational Site
    New Delhi, 100 025, India
  • Pfizer Investigational Site
    New Delhi, 110 026, India
  • Pfizer Investigational Site
    New Delhi, 11050, India
  • Pfizer Investigational Site
    Jakarta, 10430, Indonesia
  • Pfizer Investigational Site
    Jakarta, 11420, Indonesia
  • Pfizer Investigational Site
    Surabaya, 60286, Indonesia
  • Pfizer Investigational Site
    Jerusalem, 91120, Israel
  • Pfizer Investigational Site
    Jerusalem, 91240, Israel
  • Pfizer Investigational Site
    Rehovot, 76100, Israel
  • Pfizer Investigational Site
    Tel Aviv, 64239, Israel
  • Pfizer Investigational Site
    Tel Hashomer, 52621, Israel
  • Pfizer Investigational Site
    Amman, 11942, Jordan
  • Pfizer Investigational Site
    Amman, Jordan
  • Pfizer Investigational Site
    Seo-gu, Busan 602-739, Korea, Republic of
  • Pfizer Investigational Site
    Jung-gu, Daegu 700-721, Korea, Republic of
  • Pfizer Investigational Site
    Dong-gu, Kwangji 501-757, Korea, Republic of
  • Pfizer Investigational Site
    Anyang-city, Kyungki-do 431-070, Korea, Republic of
  • Pfizer Investigational Site
    Guri-City, Kyungki-do 471-701, Korea, Republic of
  • Pfizer Investigational Site
    Gangnam-gu, Seoul 135-710, Korea, Republic of
  • Pfizer Investigational Site
    Yongdeungpo-gu, Seoul 150-713, Korea, Republic of
  • Pfizer Investigational Site
    Seoul, 110-799, Korea, Republic of
  • Pfizer Investigational Site
    Seoul, 136-705, Korea, Republic of
  • Pfizer Investigational Site
    Seoul, 152-703, Korea, Republic of
  • Pfizer Investigational Site
    Sasat, Zip Code 13110, Kuwait
  • Pfizer Investigational Site
    Beirut, Lebanon
  • Pfizer Investigational Site
    Kubang Kerian, Kelantan 16150, Malaysia
  • Pfizer Investigational Site
    Seremban, Negeri Sembilan 70400, Malaysia
  • Pfizer Investigational Site
    Kuching, Sarawak, Malaysia
  • Pfizer Investigational Site
    Kuala Lumpur, 50586, Malaysia
  • Pfizer Investigational Site
    Kuala Lumpur, 59100, Malaysia
  • Pfizer Investigational Site
    Mexico, D.F 14000, Mexico
  • Pfizer Investigational Site
    Aguascalientes, C.P. 20230, Mexico
  • Pfizer Investigational Site
    Metepec, 52140, Mexico
  • Pfizer Investigational Site
    Mexico, 14000, Mexico
  • Pfizer Investigational Site
    Puebla, 72000, Mexico
  • Pfizer Investigational Site
    San Luis Potosi, 78210, Mexico
  • Pfizer Investigational Site
    Casablanca, 20000, Morocco
  • Pfizer Investigational Site
    Peshawar, N.w.f.p., Pakistan
  • Pfizer Investigational Site
    Faisalabad, Punjab, Pakistan
  • Pfizer Investigational Site
    Islamabad, Punjab, Pakistan
  • Pfizer Investigational Site
    Lahore, Punjab, Pakistan
  • Pfizer Investigational Site
    Lima, L27, Peru
  • Pfizer Investigational Site
    San Juan, Metro Manila, Philippines
  • Pfizer Investigational Site
    Phippine General Hospital, Taft Avenue, Manila City Manila, Philippines
  • Pfizer Investigational Site
    Filinvest, Alabang, Philippines
  • Pfizer Investigational Site
    Manila, Philippines
  • Pfizer Investigational Site
    Quezon City, 1100, Philippines
  • Pfizer Investigational Site
    Quezon City, Philippines
  • Pfizer Investigational Site
    Al-Khobar, Saudi Arabia
  • Pfizer Investigational Site
    Riyadh, 11426, Saudi Arabia
  • Pfizer Investigational Site
    Riyadh, 11461, Saudi Arabia
  • Pfizer Investigational Site
    Singapore, 119074, Singapore
  • Pfizer Investigational Site
    Singapore, 168752, Singapore
  • Pfizer Investigational Site
    Worcester, Cape Province, South Africa
  • Pfizer Investigational Site
    Arcadia, Pretoria, Gauteng 0083, South Africa
  • Pfizer Investigational Site
    Midrand, Johannesburg, Gauteng 1685, South Africa
  • Pfizer Investigational Site
    Sunnyside, Pretoria, Gauteng 0002, South Africa
  • Pfizer Investigational Site
    Chatsworth, Natal 4092, South Africa
  • Pfizer Investigational Site
    Cape Town, 7129, South Africa
  • Pfizer Investigational Site
    Cape Town, 7405, South Africa
  • Pfizer Investigational Site
    Cape Town, South Africa
  • Pfizer Investigational Site
    Gauteng, 2059, South Africa
  • Pfizer Investigational Site
    Kwa-Zulu Natal, South Africa
  • Pfizer Investigational Site
    Niao-Sung Hsiang, Kaohsiung 833, Taiwan
  • Pfizer Investigational Site
    Guei-Shan Shiang, Tau-Yuan Shian 333, Taiwan
  • Pfizer Investigational Site
    Changhua City, 500, Taiwan
  • Pfizer Investigational Site
    Taipei, 100, Taiwan
  • Pfizer Investigational Site
    Taipei, 112, Taiwan

Showing the first 100 of 118 sites across 27 countries.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00143234
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
First posted
Sep 2, 2005
Start date
May 2004
Completion
Jul 2005
Last update
Jan 27, 2021

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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