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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00530946
First Posted: September 18, 2007
Last Update Posted: July 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
  • Percent Change in Low Density Lipoprotein-Cholesterol [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Change in Systolic Blood Pressure From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks, and 8 weeks ]
  • Change in Diastolic Blood Pressure From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ]
  • Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ]
  • Percent Change in Total Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ]
  • Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ]
  • Percent Change in Triglycerides From Baseline to Each Observation Point [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ]
  • Change in Apolipoprotein B From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks, and 8 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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-Ku, Tokyo, Japan
Pfizer Investigational Site
Shinagawa, Tokyo, Japan
Pfizer Investigational Site
Osaka, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00530946     History of Changes
Other Study ID Numbers: A3841058
First Submitted: September 13, 2007
First Posted: September 18, 2007
Results First Submitted: March 10, 2009
Results First Posted: April 13, 2009
Last Update Posted: July 29, 2009
Last Verified: March 2009

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