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

Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Hyperlipidemia

Intervention: atorvastatin (Drug); amlodipine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

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.

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Pfizer Investigational Site, Shanghai 200025, China

Pfizer Investigational Site, Shanghai 200003, China

Pfizer Investigational Site, Shanghai 200233, China

Pfizer Investigational Site, Beijing, China

Pfizer Investigational Site, Beijing 100083, China

Pfizer Investigational Site, Beijing 100029, China

Pfizer Investigational Site, Tianjin 300211, China

Pfizer Investigational Site, Beijing 100044, China

Pfizer Investigational Site, Shanghai 200032, China

Pfizer Investigational Site, Guangzhou, Guangdong 510080, China

Pfizer Investigational Site, Guangzhou, Guangdong 510515, China

Pfizer Investigational Site, Guangzhou, Guangdong 510100, China

Pfizer Investigational Site, Nanjing, Jiangsu 210029, China

Pfizer Investigational Site, Shen Yang, Liaoning Province 110016, China

Pfizer Investigational Site, Hangzhou, Zhejiang 310016, China

Additional Information

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org Posting:

Starting date: May 2005
Ending date: February 2006
Last updated: February 20, 2007

Page last updated: June 20, 2008

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