- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00174330
Comparing Amlodipine/Atorvastatin Co-Administration To Amlodipine Alone In Patients With Hypertension And Dyslipidemia
January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
A Multi-Center, Randomized, Open-Label Study To Evaluate Efficacy And Safety Of Dual Therapy With Atorvastatin Plus Amlodipine When Compared Amlodipine Therapy Alone In The Treatment Of Subjects With Concurrent Hyperlipidemia And Hypertension.
To evaluate efficacy of the dual therapy of atorvastatin + amlodipine vs. amlodipine alone .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
330
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100083
- Pfizer Investigational Site
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Beijing, China
- Pfizer Investigational Site
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Beijing, China, 100029
- Pfizer Investigational Site
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Shanghai, China, 200025
- Pfizer Investigational Site
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Shanghai, China, 200003
- Pfizer Investigational Site
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Shanghai, China, 200233
- Pfizer Investigational Site
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Tianjin, China, 300211
- Pfizer Investigational Site
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Beijing
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Beijing, Beijing, China, 100044
- Pfizer Investigational Site
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Guangdong
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Guangzhou, Guangdong, China, 510080
- Pfizer Investigational Site
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Guangzhou, Guangdong, China, 510100
- Pfizer Investigational Site
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Guangzhou, Guangdong, China, 510515
- Pfizer Investigational Site
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Jiangsu
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Nanjing, Jiangsu, China, 210029
- Pfizer Investigational Site
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Liaoning
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Shen Yang, Liaoning, China, 110016
- Pfizer Investigational Site
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Shanghai
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Shanghai, Shanghai, China, 200032
- Pfizer Investigational Site
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Zhejiang
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Hangzhou, Zhejiang, China, 310016
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects with a diagnosis of both hyperlipidemia and hypertension.
Exclusion Criteria:
- Subjects with Type 1 diabetes mellitus or Type 2 diabetes mellitus.
- Subjects with other atherosclerotic disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To evaluate efficacy of the dual therapy of atorvastatin 10mg or 20mg + amlodipine 5mg or 10mg vs. amlodipine 5mg or 10mg alone
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Secondary Outcome Measures
Outcome Measure |
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To provide comparative evaluation of the safety profile of the dual therapy with atorvastatin + amlodipine versus amlodipine alone.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Study Completion
February 1, 2006
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Actual)
January 27, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Lipid Metabolism Disorders
- Dyslipidemias
- Hypertension
- Hyperlipidemias
- Hyperlipoproteinemias
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Atorvastatin
- Amlodipine
Other Study ID Numbers
- A3841026
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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