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

NCT ID: NCT00645424

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2004-10-31

Brief Summary

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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

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Conditions

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Hyperlipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Group Type EXPERIMENTAL

atorvastatin

Intervention Type DRUG

Atorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks

Arm B

Group Type EXPERIMENTAL

atorvastatin

Intervention Type DRUG

Atorvastatin calcium tablets 20 mg orally once daily in the evening for 12 weeks

Arm C

Group Type EXPERIMENTAL

atorvastatin

Intervention Type DRUG

Atorvastatin calcium tablets 40 mg orally once daily in the evening for 12 weeks

Interventions

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atorvastatin

Atorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks

Intervention Type DRUG

atorvastatin

Atorvastatin calcium tablets 20 mg orally once daily in the evening for 12 weeks

Intervention Type DRUG

atorvastatin

Atorvastatin calcium tablets 40 mg orally once daily in the evening for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Kaohsiung City, , Taiwan

Site Status

Pfizer Investigational Site

Kaohsiung Hsien, , Taiwan

Site Status

Pfizer Investigational Site

Taichung, , Taiwan

Site Status

Pfizer Investigational Site

Taipei, , Taiwan

Site Status

Pfizer Investigational Site

Taoyuan Hsien, , Taiwan

Site Status

Countries

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Taiwan

Related Links

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Other Identifiers

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A2581123

Identifier Type: -

Identifier Source: org_study_id

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