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

NCT00143234 | Completed Phase 3

• 1 other identifier: A3841024
• Study Type: interventional
• Target: 1,825
• Locations: 26 countries
• Sites: 116

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

Conditions

Hypertension; Hyperlipidemia

Outcome Measures

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

Interventions

Amlodipine/atorvastatin single pill DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (118)

Pfizer Investigational Site

Buenos Aires, C1181ACH, Argentina

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Buenos Aires, C1425ASS, Argentina

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Buenos Aires, C1428DCO, Argentina

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Buenos Aires, C1431FWO, Argentina

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Buenos Aires, C1437JCP, Argentina

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St Leonards, New South Wales, 2065, Australia

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Southport, Queensland, 4215, Australia

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Woolloongabba, Queensland, 4102, Australia

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Heidelberg, Victoria, 3084, Australia

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Melbourne, Victoria, 3004, Australia

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Prahran, Victoria, 3181, Australia

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Fremantle, Western Australia, 6160, Australia

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Belo Horizonte, Minas Gerais, 30110-060, Brazil

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Belo Horizonte, Minas Gerais, 30130-110, Brazil

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Belo Horizonte, Minas Gerais, 30150-221, Brazil

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Recife, Pernambuco, 50670-901, Brazil

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Botucatu, São Paulo, 18618-000, Brazil

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Campinas, São Paulo, 13012-000, Brazil

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Ribeirão Preto, São Paulo, 14048-900, Brazil

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São Paulo, São Paulo, 01244-030, Brazil

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São Paulo, São Paulo, 04038-002, Brazil

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Santiago, Región Metropolitana, Chile

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Santiago, RM, Chile

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Guatemala City, 01015, Guatemala

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Pokfulam Road, Hong Kong

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Sai Ying Pun, Hong Kong

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Hyderabad, Andhra Pradesh, 500 001, India

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Hyderabad, Andhra Pradesh, 500 033, India

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Bangalore, Karnataka, 562158, India

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Mumbai, Maharashtra, 400 007, India

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Pune, Maharashtra, 411 001, India

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Mumbai, Nagpada Junction, 400 008, India

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New Delhi, 100 025, India

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New Delhi, 110 026, India

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New Delhi, 11050, India

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Jakarta, 10430, Indonesia

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Jakarta, 11420, Indonesia

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Surabaya, 60286, Indonesia

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Jerusalem, 91120, Israel

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Jerusalem, 91240, Israel

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Rehovot, 76100, Israel

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Tel Aviv, 64239, Israel

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Tel Litwinsky, 52621, Israel

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Amman, 11942, Jordan

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Amman, Jordan

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Sasat, Zip Code 13110, Kuwait

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Beirut, Lebanon

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Kubang Kerian, Kelantan, 16150, Malaysia

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Seremban, Negeri Sembilan, 70400, Malaysia

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Kuching, Sarawak, Malaysia

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Kuala Lumpur, 50586, Malaysia

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Kuala Lumpur, 59100, Malaysia

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México, D.F, 14000, Mexico

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Aguascalientes, C.P. 20230, Mexico

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Metepec, 52140, Mexico

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México, 14000, Mexico

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Puebla City, 72000, Mexico

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San Luis Potosí City, 78210, Mexico

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Casablanca, 20000, Morocco

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Peshawar, Khyber Pakhtunkhwa, Pakistan

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Faisalabad, Punjab Province, Pakistan

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Islamabad, Punjab Province, Pakistan

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Lahore, Punjab Province, Pakistan

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Lima, L27, Peru

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San Juan City, National Capital Region, Philippines

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Phippine General Hospital, Taft Avenue, Manila City, Manila, Philippines

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Filinvest, Alabang, Philippines

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Manila, Philippines

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Quezon City, 1100, Philippines

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Quezon City, Philippines

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Khobar, Saudi Arabia

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Riyadh, 11426, Saudi Arabia

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Riyadh, 11461, Saudi Arabia

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Singapore, 119074, Singapore

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Singapore, 168752, Singapore

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Worcester, Cape Province, South Africa

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Arcadia, Pretoria, Gauteng, 0083, South Africa

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Midrand, Johannesburg, Gauteng, 1685, South Africa

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Sunnyside, Pretoria, Gauteng, 0002, South Africa

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Chatsworth, KwaZulu-Natal, 4092, South Africa

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Kwa-Zulu Natal, KwaZulu-Natal, South Africa

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Cape Town, 7129, South Africa

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Cape Town, 7405, South Africa

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Cape Town, South Africa

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Gauteng, 2059, South Africa

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Seo-gu, Busan, 602-739, South Korea

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Jung-gu, Daegu, 700-721, South Korea

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Anyang-si, Gyeonggi-do, 431-070, South Korea

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Guri-si, Gyeonggi-do, 471-701, South Korea

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Donggu, Kwangji, 501-757, South Korea

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Gangnam-gu, Seoul, 135-710, South Korea

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Yongdeungpo-gu, Seoul, 150-713, South Korea

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Seoul, 110-799, South Korea

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Seoul, 136-705, South Korea

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Seoul, 152-703, South Korea

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Niao-Sung Hsiang, Kaohsiung, 833, Taiwan

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Guei-Shan Shiang, Tau-Yuan Shian, 333, Taiwan

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Changhua, 500, Taiwan

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Taipei, 100, Taiwan

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Taipei, 112, Taiwan

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Taipei, 114, Taiwan

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KHET Rajathevee, Bangkok, 10400, Thailand

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Bangkok, 10400, Thailand

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Chiang Mai, 50200, Thailand

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Tunis, Tunisia

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Cebeci, Ankara, 06100, Turkey (Türkiye)

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Sihhiye, Ankara, 06100, Turkey (Türkiye)

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Haydarpaşa, Istanbul, 81010, Turkey (Türkiye)

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Alsancak, İzmir, Turkey (Türkiye)

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Talas, Kayseri, 38039, Turkey (Türkiye)

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Adana, 01330, Turkey (Türkiye)

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Antalya, 07059, Turkey (Türkiye)

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Diyarbakır, 21280, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Abu Dhabi, United Arab Emirates

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Dubai, United Arab Emirates

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Sharjah city, United Arab Emirates

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MeSH Terms

Conditions

Hypertension; Hyperlipidemias

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 2, 2005
• Study Start: May 1, 2004
• Study Completion: July 1, 2005
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

SG (2); LE (1); CL (2); ME (6); TH (3); GU (1); MO (1); BR (9); JO (2); SA (3); ZA (10); TU (9); MY (5); AU (7); HK (2); PA (4); PE (1); KR (10); TW (6); AE (3); AR (5); KU (1); IN (9); IL (5); ID (3); PH (6)