A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin - Full Text View

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:

MedlinePlus related topics: Cholesterol High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Atorvastatin calcium

U.S. FDA Resources

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

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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:

Hypercholesterolemia
Hypertension
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Amlodipine, atorvastatin drug combination
Atorvastatin
Calcium Channel Blockers
Membrane Transport Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on May 23, 2013