Comparing Amlodipine/Atorvastatin Co-Administration To Amlodipine Alone In Patients With Hypertension And Dyslipidemia
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.
1 other identifier
interventional
330
1 country
15
Brief Summary
To evaluate efficacy of the dual therapy of atorvastatin + amlodipine vs. amlodipine alone .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hypertension
Started May 2005
Shorter than P25 for phase_4 hypertension
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedJanuary 27, 2021
January 1, 2021
September 9, 2005
January 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate efficacy of the dual therapy of atorvastatin 10mg or 20mg + amlodipine 5mg or 10mg vs. amlodipine 5mg or 10mg alone
Secondary Outcomes (1)
To provide comparative evaluation of the safety profile of the dual therapy with atorvastatin + amlodipine versus amlodipine alone.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with a diagnosis of both hyperlipidemia and hypertension.
You may not qualify if:
- Subjects with Type 1 diabetes mellitus or Type 2 diabetes mellitus.
- Subjects with other atherosclerotic disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Pfizer Investigational Site
Beijing, Beijing Municipality, 100044, China
Pfizer Investigational Site
Guangzhou, Guangdong, 510080, China
Pfizer Investigational Site
Guangzhou, Guangdong, 510100, China
Pfizer Investigational Site
Guangzhou, Guangdong, 510515, China
Pfizer Investigational Site
Nanjing, Jiangsu, 210029, China
Pfizer Investigational Site
Shenyang, Liaoning, 110016, China
Pfizer Investigational Site
Shanghai, Shanghai Municipality, 200032, China
Pfizer Investigational Site
Hangzhou, Zhejiang, 310016, China
Pfizer Investigational Site
Beijing, 100029, China
Pfizer Investigational Site
Beijing, 100083, China
Pfizer Investigational Site
Beijing, China
Pfizer Investigational Site
Shanghai, 200003, China
Pfizer Investigational Site
Shanghai, 200025, China
Pfizer Investigational Site
Shanghai, 200233, China
Pfizer Investigational Site
Tianjin, 300211, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
May 1, 2005
Study Completion
February 1, 2006
Last Updated
January 27, 2021
Record last verified: 2021-01