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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00530946
First received: September 13, 2007
Last updated: April 28, 2009
Last verified: March 2009
  Purpose

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


Condition Intervention Phase
Hypertension
Hypercholesterolemia
Drug: Amlodipine 2.5mg/Atorvastatin 5mg
Drug: Amlodipine 2.5mg/Atorvastatin 10mg
Drug: Amlodipine 5mg/Atorvastatin 5mg
Drug: Amlodipine 5mg/Atorvastatin 10mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change in Systolic Blood Pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Percent Change in Low Density Lipoprotein-Cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Systolic Blood Pressure From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks, and 8 weeks ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
  • Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
  • Percent Change in Total Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
  • Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
  • Percent Change in Triglycerides From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
  • Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks, and 8 weeks ] [ Designated as safety issue: No ]
  • Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
  • Change in Apolipoprotein B From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks, and 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 165
Study Start Date: September 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530946

Locations
Japan
Pfizer Investigational Site
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
Annaka, Gunma, Japan
Pfizer Investigational Site
Sapporo-shi, Hokkaido, Japan
Pfizer Investigational Site
Teine, Hokkaido, Japan
Pfizer Investigational Site
Yokohama-shi, Kanagawa-ken, Japan
Pfizer Investigational Site
Yamashita-cho, Naka-ku, Kanagawa-ken, Japan
Pfizer Investigational Site
Kita-ku, Osaka-fu, Japan
Pfizer Investigational Site
Koshigaya-shi, Saitama-ken, Japan
Pfizer Investigational Site
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
Osaka, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00530946     History of Changes
Other Study ID Numbers: A3841058
Study First Received: September 13, 2007
Results First Received: March 10, 2009
Last Updated: April 28, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hypertension
Hypercholesterolemia
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Amlodipine, atorvastatin drug combination
Amlodipine
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents

ClinicalTrials.gov processed this record on September 16, 2014