Comparing Amlodipine/Atorvastatin Co-Administration To Amlodipine Alone In Patients With Hypertension And Dyslipidemia

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 9, 2005
Last updated: February 20, 2007
Last verified: February 2007
To evaluate efficacy of the dual therapy of atorvastatin + amlodipine vs. amlodipine alone .

Condition Intervention Phase
Drug: atorvastatin
Drug: amlodipine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To evaluate efficacy of the dual therapy of atorvastatin 10mg or 20mg + amlodipine 5mg or 10mg vs. amlodipine 5mg or 10mg alone

Secondary Outcome Measures:
  • To provide comparative evaluation of the safety profile of the dual therapy with atorvastatin + amlodipine versus amlodipine alone.

Estimated Enrollment: 330
Study Start Date: May 2005
Estimated Study Completion Date: February 2006

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00174330

China, Beijing
Pfizer Investigational Site
Beijing, Beijing, China, 100044
China, Guangdong
Pfizer Investigational Site
Guangzhou, Guangdong, China, 510080
Pfizer Investigational Site
Guangzhou, Guangdong, China, 510100
Pfizer Investigational Site
Guangzhou, Guangdong, China, 510515
China, Jiangsu
Pfizer Investigational Site
Nanjing, Jiangsu, China, 210029
China, Liaoning
Pfizer Investigational Site
Shen Yang, Liaoning, China, 110016
China, Shanghai
Pfizer Investigational Site
Shanghai, Shanghai, China, 200032
China, Zhejiang
Pfizer Investigational Site
Hangzhou, Zhejiang, China, 310016
Pfizer Investigational Site
Beijing, China
Pfizer Investigational Site
Beijing, China, 100083
Pfizer Investigational Site
Beijing, China, 100029
Pfizer Investigational Site
Shanghai, China, 200003
Pfizer Investigational Site
Shanghai, China, 200025
Pfizer Investigational Site
Shanghai, China, 200233
Pfizer Investigational Site
Tianjin, China, 300211
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided Identifier: NCT00174330     History of Changes
Other Study ID Numbers: A3841026 
Study First Received: September 9, 2005
Last Updated: February 20, 2007
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Anticholesteremic Agents
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents processed this record on February 04, 2016