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

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00645424
Collaborator
(none)
155
Enrollment
5
Locations
3
Arms
10
Duration (Months)
31
Patients Per Site
3.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
155 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Dec 1, 2003
Actual Study Completion Date :
Oct 1, 2004

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Percentage change in LDL-C levels from baseline to Week 12 [Week 12]

  2. Percentage of subjects with low-density lipoprotein cholesterol (LDL-C) levels of <100 mg/dL (LDL-C responders) at Week 12 [Week 12]

Secondary Outcome Measures

  1. Percentage change from baseline in TC, high-density lipoprotein cholesterol, triglycerides, and high sensitivity C-reactive protein at Weeks 4, 8, and 12 [Weeks 4, 8, and 12]

  2. Adverse events at Weeks 4, 8, and 12 [Baseline and at Weeks 4, 8, and 12]

  3. Clinical laboratory changes at Weeks 4, 8, and 12 [Screening and at Weeks 4, 8, and 12]

  4. Vital signs at Weeks 4, 8, and 12 [Screening and at Weeks 4, 8, and 12]

  5. Percentage change in LDL-C levels from baseline at Weeks 4 and 8 [Weeks 4 and 8]

  6. Percentage of LDL-C responders at Weeks 4 and 8 [Weeks 4 and 8]

  7. Percentage of subjects with total cholesterol (TC) levels of <160 mg/dL (TC responders) at Weeks 4, 8, and 12 [Weeks 4, 8, and 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Kaohsiung Hsien Taiwan
2 Pfizer Investigational Site Kaohsiung Taiwan
3 Pfizer Investigational Site Taichung Taiwan
4 Pfizer Investigational Site Taipei Taiwan
5 Pfizer Investigational Site Taoyuan Hsien Taiwan

Sponsors and Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00645424
Other Study ID Numbers:
  • A2581123
First Posted:
Mar 27, 2008
Last Update Posted:
Feb 18, 2021
Last Verified:
Feb 1, 2021
Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Atorvastatin

Study Results

No Results Posted as of Feb 18, 2021