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

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00174330

Collaborator

(none)

330

Enrollment

Locations

9.1

Duration (Months)

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypertension Hyperlipidemia	Drug: atorvastatin Drug: amlodipine	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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.

Study Start Date :

May 1, 2005

Study Completion Date :

Feb 1, 2006

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Beijing	Beijing	China	100044
2	Pfizer Investigational Site	Guangzhou	Guangdong	China	510080
3	Pfizer Investigational Site	Guangzhou	Guangdong	China	510100
4	Pfizer Investigational Site	Guangzhou	Guangdong	China	510515
5	Pfizer Investigational Site	Nanjing	Jiangsu	China	210029
6	Pfizer Investigational Site	Shen Yang	Liaoning	China	110016
7	Pfizer Investigational Site	Shanghai	Shanghai	China	200032
8	Pfizer Investigational Site	Hangzhou	Zhejiang	China	310016
9	Pfizer Investigational Site	Beijing		China	100029
10	Pfizer Investigational Site	Beijing		China	100083
11	Pfizer Investigational Site	Beijing		China
12	Pfizer Investigational Site	Shanghai		China	200003
13	Pfizer Investigational Site	Shanghai		China	200025
14	Pfizer Investigational Site	Shanghai		China	200233
15	Pfizer Investigational Site	Tianjin		China	300211