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Trial record 1 of 1 for:    NCT00645424
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A Study To Evaluate The Safety And Efficacy Of Atorvastatin In Patients With Diabetes And High Cholesterol

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ClinicalTrials.gov Identifier: NCT00645424
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : May 5, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 24, 2008
First Posted Date  ICMJE March 27, 2008
Last Update Posted Date May 5, 2008
Study Start Date  ICMJE December 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2008)
  • Percentage change in LDL-C levels from baseline to Week 12 [ Time Frame: Week 12 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2008)
  • 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 ]
  • Adverse events at Weeks 4, 8, and 12 [ Time Frame: Baseline and at Weeks 4, 8, and 12 ]
  • Clinical laboratory changes at Weeks 4, 8, and 12 [ Time Frame: Screening and at Weeks 4, 8, and 12 ]
  • Vital signs at Weeks 4, 8, and 12 [ Time Frame: Screening and at Weeks 4, 8, and 12 ]
  • Percentage change in LDL-C levels from baseline at Weeks 4 and 8 [ Time Frame: Weeks 4 and 8 ]
  • Percentage of LDL-C responders at Weeks 4 and 8 [ Time Frame: Weeks 4 and 8 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Safety And Efficacy Of Atorvastatin In Patients With Diabetes And High Cholesterol
Official Title  ICMJE A Randomized, 12-Week, Open Labeled Study To Evaluate The Efficacy And Safety Of Once Daily Atorvastatin In Diabetes Mellitus Type 2 With Hyperlipidemia
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hyperlipidemias
Intervention  ICMJE
  • Drug: atorvastatin
    Atorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks
  • Drug: atorvastatin
    Atorvastatin calcium tablets 20 mg orally once daily in the evening for 12 weeks
  • Drug: atorvastatin
    Atorvastatin calcium tablets 40 mg orally once daily in the evening for 12 weeks
Study Arms  ICMJE
  • Experimental: Arm A
    Intervention: Drug: atorvastatin
  • Experimental: Arm B
    Intervention: Drug: atorvastatin
  • Experimental: Arm C
    Intervention: Drug: atorvastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2008)
155
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00645424
Other Study ID Numbers  ICMJE A2581123
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP