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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00530946

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Atorvastatin 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
CI-1038 2.5mg/5mg: Active Comparator	Drug: Amlodipine 2.5mg/Atorvastatin 5mg Single pill combination, dosed once daily for 8 weeks
CI-1038 2.5mg/10mg: Active Comparator	Drug: Amlodipine 2.5mg/Atorvastatin 10mg Single pill combination, dosed once daily for 8 weeks
CI-1038 5mg/5mg: Active Comparator	Drug: Amlodipine 5mg/Atorvastatin 5mg Single pill combination, dosed once daily for 8 weeks
CI-1038 5mg/10mg: Active Comparator	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
Osaka, Japan
Japan, Fukuoka-ken
Pfizer Investigational Site
Kitakyushu-shi, Fukuoka-ken, Japan
Pfizer Investigational Site
Fukuoka-shi, Fukuoka-ken, Japan
Pfizer Investigational Site
Maebaru-shi, Fukuoka-ken, Japan
Pfizer Investigational Site
Kurume-shi, Fukuoka-ken, Japan
Japan, Gunma
Pfizer Investigational Site
Annaka, Gunma, Japan
Japan, Hokkaido
Pfizer Investigational Site
Teine, Hokkaido, Japan
Pfizer Investigational Site
Sapporo-shi, Hokkaido, Japan
Japan, Kanagawa-ken
Pfizer Investigational Site
Yokohama-shi, Kanagawa-ken, Japan
Japan, Naka-ku, Kanagawa-ken
Pfizer Investigational Site
Yamashita-cho, Naka-ku, Kanagawa-ken, Japan
Japan, Osaka-fu
Pfizer Investigational Site
Kita-ku, Osaka-fu, Japan
Japan, Saitama-ken
Pfizer Investigational Site
Koshigaya-shi, Saitama-ken, Japan
Japan, Tokyo
Pfizer Investigational Site
Shinagawa-Ku, Tokyo, Japan
Pfizer Investigational Site
Setagaya-ku, Tokyo, Japan
Pfizer Investigational Site
Shinagawa, Tokyo, Japan
Pfizer Investigational Site
Chofu, Tokyo, Japan
Pfizer Investigational Site
Kiyose, Tokyo, 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

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

No publications provided

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

Additional relevant MeSH terms:

Antimetabolites
Vasodilator Agents
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Vascular Diseases
Calcium Channel Blockers
Enzyme Inhibitors
Anticholesteremic Agents
Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Antihypertensive Agents
Pharmacologic Actions
Amlodipine
Membrane Transport Modulators
Therapeutic Uses
Cardiovascular Diseases
Hypercholesterolemia
Dyslipidemias
Atorvastatin
Hypertension
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 25, 2009