A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD)

NCT ID: NCT00644709

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

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2005-03-31

Brief Summary

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A study of the long-term (1 year) effectiveness of atorvastatin to keep patients of high cardiovascular risk at the LDL cholesterol goal of \<115 mg/dL

Detailed Description

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Conditions

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Dyslipidemias

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Atorvastatin tablets at starting doses of 10, 20, 40, or 80 mg once daily. Three dose adjustments were allowed at baseline, Week 17, and Week 34. Patients who did not meet the LDL-C target at any of these time points had their doses doubled except for those who were on the 80 mg dose. Treatment was given for 52 weeks.

Interventions

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Atorvastatin

Atorvastatin tablets at starting doses of 10, 20, 40, or 80 mg once daily. Three dose adjustments were allowed at baseline, Week 17, and Week 34. Patients who did not meet the LDL-C target at any of these time points had their doses doubled except for those who were on the 80 mg dose. Treatment was given for 52 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Completion of base study
* Dyslipidemia and at high risk of CHD

Exclusion Criteria

* Impaired liver function
* Gastrointestinal disease that could limit drug absorption
Minimum Eligible Age

30 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

Antwerp, , Belgium

Site Status

Pfizer Investigational Site

Brasschaat, , Belgium

Site Status

Pfizer Investigational Site

Brussels, , Belgium

Site Status

Pfizer Investigational Site

Genk, , Belgium

Site Status

Pfizer Investigational Site

Ghent, , Belgium

Site Status

Pfizer Investigational Site

Gilly (charleroi), , Belgium

Site Status

Pfizer Investigational Site

La Louvière, , Belgium

Site Status

Pfizer Investigational Site

Mechelen, , Belgium

Site Status

Pfizer Investigational Site

Menen, , Belgium

Site Status

Pfizer Investigational Site

Merksem, , Belgium

Site Status

Pfizer Investigational Site

Mortsel, , Belgium

Site Status

Pfizer Investigational Site

Roeselare, , Belgium

Site Status

Pfizer Investigational Site

Seraing, , Belgium

Site Status

Pfizer Investigational Site

Wilrijk, , Belgium

Site Status

Pfizer Investigational Site

Wingene, , Belgium

Site Status

Countries

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Belgium

Related Links

Other Identifiers

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A2581112

Identifier Type: -

Identifier Source: org_study_id

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