Atorvastatin Study For The Treatment Of High Cholesterol In Patients From Thailand

NCT ID: NCT00647543

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

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2004-04-30

Brief Summary

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The purpose of this study is to evaluate the efficacy of atorvastatin in lowering cholesterol on patients from Thailand with high cholesterol.

Detailed Description

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Conditions

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Dyslipidemias

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High Risk

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.

Low Risk

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.

Medium Risk

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.

Interventions

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Atorvastatin

Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.

Intervention Type DRUG

Atorvastatin

Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.

Intervention Type DRUG

Atorvastatin

Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Dyslipidemic patients who were eligible for lipid lowering therapy
* Willingness to follow study diet for 1 month prior to screening and for the duration of the study

Exclusion Criteria

* Use of other lipid lowering agents (6-week washout period)
* Uncontrolled high blood pressure
* Impaired liver function
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

Bangkok, , Thailand

Site Status

Pfizer Investigational Site

Bangkok, , Thailand

Site Status

Pfizer Investigational Site

Chiang Mai, , Thailand

Site Status

Pfizer Investigational Site

, ,

Site Status

Countries

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Thailand

Related Links

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Other Identifiers

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A2581111

Identifier Type: -

Identifier Source: org_study_id

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