search
Back to results

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

Primary Purpose

Hypertension, Hyperlipidemia

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
atorvastatin
amlodipine
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

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.

Full Information

First Posted
September 9, 2005
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00174330
Brief Title
Comparing Amlodipine/Atorvastatin Co-Administration To Amlodipine Alone In Patients With Hypertension And Dyslipidemia
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 Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
atorvastatin
Intervention Type
Drug
Intervention Name(s)
amlodipine
Primary Outcome Measure Information:
Title
To evaluate efficacy of the dual therapy of atorvastatin 10mg or 20mg + amlodipine 5mg or 10mg vs. amlodipine 5mg or 10mg alone
Secondary Outcome Measure Information:
Title
To provide comparative evaluation of the safety profile of the dual therapy with atorvastatin + amlodipine versus amlodipine alone.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Pfizer Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Pfizer Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510100
Country
China
Facility Name
Pfizer Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Pfizer Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Pfizer Investigational Site
City
Shen Yang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Pfizer Investigational Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100083
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
200233
Country
China
Facility Name
Pfizer Investigational Site
City
Tianjin
ZIP/Postal Code
300211
Country
China

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3841026&StudyName=Comparing+Amlodipine%2FAtorvastatin+Co%2DAdministration+To+Amlodipine+Alone+In+Patients+With++Hypertension+And+Dyslipidemia+
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs