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

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension; Hypercholesterolemia
• Intervention / Treatment: Drug: Amlodipine 2.5mg/Atorvastatin 5mg; Drug: Amlodipine 2.5mg/Atorvastatin 10mg; Drug: Amlodipine 5mg/Atorvastatin 5mg; Drug: Amlodipine 5mg/Atorvastatin 10mg

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan
    • Pfizer Investigational Site
  • Fukuoka-ken
    • Fukuoka-shi, Fukuoka-ken, Japan
      • Pfizer Investigational Site
    • Kitakyushu-shi, Fukuoka-ken, Japan
      • Pfizer Investigational Site
    • Kurume-shi, Fukuoka-ken, Japan
      • Pfizer Investigational Site
    • Maebaru-shi, Fukuoka-ken, Japan
      • Pfizer Investigational Site
  • Gunma
    • Annaka, Gunma, Japan
      • Pfizer Investigational Site
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan
      • Pfizer Investigational Site
    • Teine, Hokkaido, Japan
      • Pfizer Investigational Site
  • Kanagawa-ken
    • Yokohama-shi, Kanagawa-ken, Japan
      • Pfizer Investigational Site
  • Naka-ku, Kanagawa-ken
    • Yamashita-cho, Naka-ku, Kanagawa-ken, Japan
      • Pfizer Investigational Site
  • Osaka-fu
    • Kita-ku, Osaka-fu, Japan
      • Pfizer Investigational Site
  • Saitama-ken
    • Koshigaya-shi, Saitama-ken, Japan
      • Pfizer Investigational Site
  • Tokyo
    • Chofu, Tokyo, Japan
      • Pfizer Investigational Site
    • Kiyose, Tokyo, Japan
      • Pfizer Investigational Site
    • Setagaya-ku, Tokyo, Japan
      • Pfizer Investigational Site
    • Shinagawa, Tokyo, Japan
      • Pfizer Investigational Site
    • Shinagawa-Ku, Tokyo, Japan
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CI-1038 2.5mg/5mg	Drug: Amlodipine 2.5mg/Atorvastatin 5mg; Single pill combination, dosed once daily for 8 weeks
Active Comparator: CI-1038 2.5mg/10mg	Drug: Amlodipine 2.5mg/Atorvastatin 10mg; Single pill combination, dosed once daily for 8 weeks
Active Comparator: CI-1038 5mg/5mg	Drug: Amlodipine 5mg/Atorvastatin 5mg; Single pill combination, dosed once daily for 8 weeks
Active Comparator: CI-1038 5mg/10mg	Drug: Amlodipine 5mg/Atorvastatin 10mg; Single pill combination, dosed once daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Systolic Blood Pressure	Value at Week 8 minus value at baseline	8 weeks
Percent Change in Low Density Lipoprotein-Cholesterol	Percent of "value at Week 8 minus value at baseline" over value at baseline	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Systolic Blood Pressure From Baseline to Each Observation Point	Value at Week 2, Week 4, or Week 8 minus value at baseline	2 weeks, 4 weeks, and 8 weeks
Change in Diastolic Blood Pressure From Baseline to Each Observation Point	Value at Week 2, Week 4, or Week 8 minus value at baseline	2 weeks, 4 weeks , and 8 weeks
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	2 weeks, 4 weeks , and 8 weeks
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	2 weeks, 4 weeks , and 8 weeks
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	2 weeks, 4 weeks , and 8 weeks
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	2 weeks, 4 weeks , and 8 weeks
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	2 weeks, 4 weeks, and 8 weeks
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	2 weeks, 4 weeks , and 8 weeks
Change in Apolipoprotein B From Baseline to Each Observation Point	Value at Week 2, Week 4, or Week 8 minus value at baseline	2 weeks, 4 weeks, and 8 weeks

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: September 13, 2007
• First Submitted That Met QC Criteria: September 14, 2007
• First Posted (Estimate): September 18, 2007

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertension; Hypercholesterolemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Atorvastatin; Amlodipine
• Other Study ID Numbers: A3841058