A Study Of The Efficacy Of Atorvastatin For Lowering Cholesterol In High-Risk Patients With High Cholesterol

NCT ID: NCT00644670

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

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2004-03-31

Brief Summary

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The purpose of the study is to evaluate the effectiveness of atorvastatin in lowering cholesterol and getting these high risk patients to their goals of LDL \<115 mg/dl across starting doses of 10 mg, 20 mg, or 40 mg with one step titration.

Detailed Description

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Conditions

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Dyslipidemias

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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Previous Treatment with a Usual Maintenance Dose of a Statin

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

In previously treated patients, starting atorvastatin doses (oral tablets given once daily) of 20 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline) or 40 mg (in patients with LDL-C levels between 165 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled.

Statin-Naive

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

In statin-naive patients, starting atorvastatin doses (oral tablets given once daily) of 10 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline), 20 mg (in patients with LDL-C levels between 165 and 174 mg/dL at baseline), or 40 mg (in patients with LDL-C levels between 175 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled.

Interventions

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Atorvastatin

In previously treated patients, starting atorvastatin doses (oral tablets given once daily) of 20 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline) or 40 mg (in patients with LDL-C levels between 165 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled.

Intervention Type DRUG

Atorvastatin

In statin-naive patients, starting atorvastatin doses (oral tablets given once daily) of 10 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline), 20 mg (in patients with LDL-C levels between 165 and 174 mg/dL at baseline), or 40 mg (in patients with LDL-C levels between 175 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Dyslipidemia
* At a high risk for coronary heart disease

Exclusion Criteria

* Use of higher than usual maintenance doses of statin drugs at screening
* Uncontrolled diabetes or high blood pressure
* Impaired liver function
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

Edegem, , 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

Liège, , 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

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Other Identifiers

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A2581099

Identifier Type: -

Identifier Source: org_study_id

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