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
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