A Study To Evaluate The Safety And Efficacy Of Atorvastatin In Patients With Diabetes And High Cholesterol - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00645424

Purpose

The purpose of this study is to evaluate the efficacy and safety of atorvastatin for the treatment of Taiwanese patients with diabetes and high cholesterol.

Condition	Intervention	Phase
Hyperlipidemias	Drug: atorvastatin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, 12-Week, Open Labeled Study To Evaluate The Efficacy And Safety Of Once Daily Atorvastatin In Diabetes Mellitus Type 2 With Hyperlipidemia

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Diabetes

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Percentage change in LDL-C levels from baseline to Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Percentage of subjects with low-density lipoprotein cholesterol (LDL-C) levels of <100 mg/dL (LDL-C responders) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage change from baseline in TC, high-density lipoprotein cholesterol, triglycerides, and high sensitivity C-reactive protein at Weeks 4, 8, and 12 [ Time Frame: Weeks 4, 8, and 12 ] [ Designated as safety issue: No ]
Adverse events at Weeks 4, 8, and 12 [ Time Frame: Baseline and at Weeks 4, 8, and 12 ] [ Designated as safety issue: Yes ]
Clinical laboratory changes at Weeks 4, 8, and 12 [ Time Frame: Screening and at Weeks 4, 8, and 12 ] [ Designated as safety issue: Yes ]
Vital signs at Weeks 4, 8, and 12 [ Time Frame: Screening and at Weeks 4, 8, and 12 ] [ Designated as safety issue: Yes ]
Percentage change in LDL-C levels from baseline at Weeks 4 and 8 [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]
Percentage of LDL-C responders at Weeks 4 and 8 [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]
Percentage of subjects with total cholesterol (TC) levels of <160 mg/dL (TC responders) at Weeks 4, 8, and 12 [ Time Frame: Weeks 4, 8, and 12 ] [ Designated as safety issue: No ]

Enrollment:	155
Study Start Date:	December 2003
Study Completion Date:	October 2004

Arms	Assigned Interventions
Arm A: Experimental	Drug: atorvastatin Atorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks
Arm B: Experimental	Drug: atorvastatin Atorvastatin calcium tablets 20 mg orally once daily in the evening for 12 weeks
Arm C: Experimental	Drug: atorvastatin Atorvastatin calcium tablets 40 mg orally once daily in the evening for 12 weeks

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult Taiwanese outpatients with type 2 diabetes mellitus and high cholesterol
Hemoglobin A1c levels of ≤10%, LDL-C levels of ≥130 mg/dL, and serum triglyceride levels of <400 mg/dL

Exclusion Criteria:

Type I diabetes mellitus
Secondary causes of high cholesterol
Elevated liver enzymes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645424

Locations

Taiwan
Pfizer Investigational Site
Taichung, Taiwan
Pfizer Investigational Site
Kaohsiung Hsien, Taiwan
Pfizer Investigational Site
Kaohsiung, Taiwan
Pfizer Investigational Site
Taoyuan Hsien, Taiwan
Pfizer Investigational Site
Taipei, Taiwan

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:	A2581123
Study First Received:	March 24, 2008
Last Updated:	April 28, 2008
ClinicalTrials.gov Identifier:	NCT00645424 History of Changes
Health Authority:	Taiwan: Department of Health

Study placed in the following topic categories:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Antilipemic Agents
Diabetes Mellitus
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Calcium, Dietary
Diabetes Mellitus, Type 2
Metabolic Disorder
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 10, 2009