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A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin

Primary Purpose

Hypertension, Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Amlodipine 2.5mg/Atorvastatin 5mg
Amlodipine 2.5mg/Atorvastatin 10mg
Amlodipine 5mg/Atorvastatin 5mg
Amlodipine 5mg/Atorvastatin 10mg
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male or female >=20 to <80 years of age at Visit 1.
  • The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP >=140 mmHg and <180 mmHg,
  • LDL-C >=140 mg/dL and <250 mg/dL at Visit 3 (Week -2) and 4 (Week -1).

Exclusion Criteria:

  • Subjects who had experienced the following coronary artery disease within the past 3 months.
  • Myocardial infarction
  • Receiving PCI（percutaneous coronary intervention）or CABG (coronary artery bypass grafting)
  • Any clinically meaningful valvular disease
  • Subjects with a history of cerebrovascular diseases such as stroke or transient ischemic attack within the past 3 months.

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
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

CI-1038 2.5mg/5mg

CI-1038 2.5mg/10mg

CI-1038 5mg/5mg

CI-1038 5mg/10mg

Arm Description

Outcomes

Primary Outcome Measures

Change in Systolic Blood Pressure
Value at Week 8 minus value at baseline
Percent Change in Low Density Lipoprotein-Cholesterol
Percent of "value at Week 8 minus value at baseline" over value at baseline

Secondary Outcome Measures

Change in Systolic Blood Pressure From Baseline to Each Observation Point
Value at Week 2, Week 4, or Week 8 minus value at baseline
Change in Diastolic Blood Pressure From Baseline to Each Observation Point
Value at Week 2, Week 4, or Week 8 minus value at baseline
Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline
Percent Change in Total Cholesterol From Baseline to Each Observation Point
Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline
Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline
Percent Change in Triglycerides From Baseline to Each Observation Point
Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline
Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point
Value at Week 2, Week 4, or Week 8 minus value at baseline
Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point
Value at Week 2, Week 4, or Week 8 minus value at baseline
Change in Apolipoprotein B From Baseline to Each Observation Point
Value at Week 2, Week 4, or Week 8 minus value at baseline

Full Information

First Posted
September 13, 2007
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00530946
Brief Title
A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin
Official Title
A Multi-Center, Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin In The Treatment Of Concurrent Hypertension And Hyper-LDL-Cholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CI-1038 2.5mg/5mg
Arm Type
Active Comparator
Arm Title
CI-1038 2.5mg/10mg
Arm Type
Active Comparator
Arm Title
CI-1038 5mg/5mg
Arm Type
Active Comparator
Arm Title
CI-1038 5mg/10mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Amlodipine 2.5mg/Atorvastatin 5mg
Intervention Description
Single pill combination, dosed once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Amlodipine 2.5mg/Atorvastatin 10mg
Intervention Description
Single pill combination, dosed once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Amlodipine 5mg/Atorvastatin 5mg
Intervention Description
Single pill combination, dosed once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Amlodipine 5mg/Atorvastatin 10mg
Intervention Description
Single pill combination, dosed once daily for 8 weeks
Primary Outcome Measure Information:
Title
Change in Systolic Blood Pressure
Description
Value at Week 8 minus value at baseline
Time Frame
8 weeks
Title
Percent Change in Low Density Lipoprotein-Cholesterol
Description
Percent of "value at Week 8 minus value at baseline" over value at baseline
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in Systolic Blood Pressure From Baseline to Each Observation Point
Description
Value at Week 2, Week 4, or Week 8 minus value at baseline
Time Frame
2 weeks, 4 weeks, and 8 weeks
Title
Change in Diastolic Blood Pressure From Baseline to Each Observation Point
Description
Value at Week 2, Week 4, or Week 8 minus value at baseline
Time Frame
2 weeks, 4 weeks , and 8 weeks
Title
Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
Description
Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline
Time Frame
2 weeks, 4 weeks , and 8 weeks
Title
Percent Change in Total Cholesterol From Baseline to Each Observation Point
Description
Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline
Time Frame
2 weeks, 4 weeks , and 8 weeks
Title
Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
Description
Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline
Time Frame
2 weeks, 4 weeks , and 8 weeks
Title
Percent Change in Triglycerides From Baseline to Each Observation Point
Description
Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline
Time Frame
2 weeks, 4 weeks , and 8 weeks
Title
Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point
Description
Value at Week 2, Week 4, or Week 8 minus value at baseline
Time Frame
2 weeks, 4 weeks, and 8 weeks
Title
Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point
Description
Value at Week 2, Week 4, or Week 8 minus value at baseline
Time Frame
2 weeks, 4 weeks , and 8 weeks
Title
Change in Apolipoprotein B From Baseline to Each Observation Point
Description
Value at Week 2, Week 4, or Week 8 minus value at baseline
Time Frame
2 weeks, 4 weeks, and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male or female >=20 to <80 years of age at Visit 1. The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP >=140 mmHg and <180 mmHg, LDL-C >=140 mg/dL and <250 mg/dL at Visit 3 (Week -2) and 4 (Week -1). Exclusion Criteria: Subjects who had experienced the following coronary artery disease within the past 3 months. Myocardial infarction Receiving PCI（percutaneous coronary intervention）or CABG (coronary artery bypass grafting) Any clinically meaningful valvular disease Subjects with a history of cerebrovascular diseases such as stroke or transient ischemic attack within the past 3 months.
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
Fukuoka-shi
State/Province
Fukuoka-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kitakyushu-shi
State/Province
Fukuoka-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kurume-shi
State/Province
Fukuoka-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Maebaru-shi
State/Province
Fukuoka-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Annaka
State/Province
Gunma
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Teine
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yokohama-shi
State/Province
Kanagawa-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yamashita-cho
State/Province
Naka-ku, Kanagawa-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kita-ku
State/Province
Osaka-fu
Country
Japan
Facility Name
Pfizer Investigational Site
City
Koshigaya-shi
State/Province
Saitama-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chofu
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kiyose
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinagawa-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinagawa
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Osaka
Country
Japan

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3841058&StudyName=A%20Randomized%20Study%20To%20Evaluate%20Efficacy%20And%20Safety%20Of%20A%20Fixed%20Combination%20Therapy%20Of%20Amlodipine%20And%20Atorvastatin
Description
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A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin

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