Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets

NCT ID: NCT00442325

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

595 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-02-29

Brief Summary

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European physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol. The study evaluates if selecting the starting dose based on baseline and target LDL-C cholesterol would provide better results (ie proportion of subjects resching target)

Detailed Description

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Conditions

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Coronary Arteriosclerosis Diabetes Mellitus, Type 2 Cerebrovascular Accident Dyslipidemia Peripheral Vascular Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Atorvastatin (Lipitor)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* High cholesterol blood levels (LDL-cholesterol above 100 mg/dL up to 220 mg/dL.
* Triglycerides up to 600 mg/dL.
* History of coronary artery disease (ex.: heart attack, angina), stroke, diabetes or at high risk of such events.

Exclusion Criteria

* Pregnancy or lactation, use of high statin doses (\>40mg) at baseline, liver or renal problems
* Use of other drugs that would interfere with evaluation of efficacy or cause safety problems
* Uncontrolled hypertension, diabetes or hypothyroidism
* Recent cardiac event of procedure
* High baseline CPK levels
Minimum Eligible Age

18 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

Ioannina, , Greece

Site Status

Pfizer Investigational Site

Kallithea, Athens, , Greece

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Pfizer Investigational Site

Pireaus, , Greece

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Thessaloniki, , Greece

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Budapest, , Hungary

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Gyula, , Hungary

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Kecskemét, , Hungary

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Nyíregyháza, , Hungary

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Szekszárd, , Hungary

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Tullamore, CO. Offlay, Ireland

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Pfizer Investigational Site

Tallaght, Dublin, Ireland

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Pfizer Investigational Site

Gorey, Wexford, Ireland

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Cork, , Ireland

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Dublin, , Ireland

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Galway, , Ireland

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Częstochowa, , Poland

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Poznan, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Zabrze, , Poland

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Aveiro, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Vila Franca de Xira, , Portugal

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Moscow, , Russia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Bern, , Switzerland

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Geneva, , Switzerland

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Mendrisio, , Switzerland

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Zurich, , Switzerland

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Pfizer Investigational Site

, ,

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Countries

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Greece Hungary Ireland Poland Portugal Russia Slovakia Switzerland

References

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Farsang C, Athyros V, Gaw A; ACTFAST-2 investigators and Steering Committee members. A multicentre, open study to assess the effect of individualizing starting doses of atorvastatin according to baseline LDL-C levels on achieving cholesterol targets: the Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration (ACTFAST-2) study. Curr Med Res Opin. 2007 Aug;23(8):1945-56. doi: 10.1185/030079907X223242.

Reference Type DERIVED
PMID: 17626713 (View on PubMed)

Related Links

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Other Identifiers

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A2581095

Identifier Type: -

Identifier Source: org_study_id

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