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Register:	ClinicalTrials.gov
Last refreshed on:	1 March 2021
Main ID:	NCT00645424
Date of registration:	24/03/2008
Prospective Registration:	No
Primary sponsor:	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Public title:	A Study To Evaluate The Safety And Efficacy Of Atorvastatin In Patients With Diabetes And High Cholesterol
Scientific 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
Date of first enrolment:	December 2003
Target sample size:	155
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00645424
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 4

Countries of recruitment
Taiwan

Contacts

Name:	Pfizer CT.gov Call Center
Address:
Telephone:
Email:
Affiliation:	Pfizer

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hyperlipidemias

Intervention(s)

Drug: atorvastatin

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

Clinical laboratory changes at Weeks 4, 8, and 12 [Time Frame: Screening and at Weeks 4, 8, and 12]

Percentage of LDL-C responders at Weeks 4 and 8 [Time Frame: Weeks 4 and 8]

Adverse events at Weeks 4, 8, and 12 [Time Frame: Baseline 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]

Vital signs at Weeks 4, 8, and 12 [Time Frame: Screening and at Weeks 4, 8, and 12]

Secondary ID(s)

A2581123

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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