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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00645424
First received: March 24, 2008
Last updated: April 28, 2008
Last verified: April 2008
  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 4

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 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:


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
Experimental: Arm A Drug: atorvastatin
Atorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks
Experimental: Arm B Drug: atorvastatin
Atorvastatin calcium tablets 20 mg orally once daily in the evening for 12 weeks
Experimental: Arm C 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
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: NCT00645424

Locations
Taiwan
Pfizer Investigational Site
Kaohsiung, Taiwan
Pfizer Investigational Site
Kaohsiung Hsien, Taiwan
Pfizer Investigational Site
Taichung, Taiwan
Pfizer Investigational Site
Taipei, Taiwan
Pfizer Investigational Site
Taoyuan Hsien, Taiwan
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: NCT00645424     History of Changes
Other Study ID Numbers: A2581123
Study First Received: March 24, 2008
Last Updated: April 28, 2008
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014