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NCT00174330 Clinical Trial

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

Hypertension Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00174330
Other study ID # A3841026
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 2005
Est. completion date February 2006

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate efficacy of the dual therapy of atorvastatin + amlodipine vs. amlodipine alone .

Recruitment information / eligibility
Status Completed
Enrollment 330
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• atorvastatin

• amlodipine

Locations
Country Name City State
China Pfizer Investigational Site Beijing Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Guangzhou Guangdong
China Pfizer Investigational Site Guangzhou Guangdong
China Pfizer Investigational Site Guangzhou Guangdong
China Pfizer Investigational Site Hangzhou Zhejiang
China Pfizer Investigational Site Nanjing Jiangsu
China Pfizer Investigational Site Shanghai
China Pfizer Investigational Site Shanghai
China Pfizer Investigational Site Shanghai
China Pfizer Investigational Site Shanghai Shanghai
China Pfizer Investigational Site Shen Yang Liaoning
China Pfizer Investigational Site Tianjin

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate efficacy of the dual therapy of atorvastatin 10mg or 20mg + amlodipine 5mg or 10mg vs. amlodipine 5mg or 10mg alone
Secondary To provide comparative evaluation of the safety profile of the dual therapy with atorvastatin + amlodipine versus amlodipine alone.
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