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Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

NCT ID: NCT00309738

Last Updated: 2010-03-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-10-31

Brief Summary

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The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin in patients with risk factors for heart disease.

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Detailed Description

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Conditions

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Hypercholesterolemia Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pitavastatin 4 mg QD

Pitavastatin 4 mg once daily

Group Type EXPERIMENTAL

pitavastatin

Intervention Type DRUG

Simvastatin 40 mg QD

Simvastatin 40 mg once daily

Group Type ACTIVE_COMPARATOR

simvastatin

Intervention Type DRUG

Interventions

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pitavastatin

Intervention Type DRUG

simvastatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and females (18-75 years of age)
* At least two cardiovascular disease risk factors
* Must have been following a restrictive diet
* Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion Criteria

* Homozygous familial hypercholesterolemia
* Conditions which may cause secondary dyslipidemia
* Uncontrolled diabetes mellitus
* Abnormal pancreatic, liver or renal function
* Abnormal serum creatine kinase (CK) above the pre-specified level
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kowa Research Europe

INDUSTRY

Sponsor Role lead

Responsible Party

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Kowa Research Europe

Principal Investigators

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Dragos Budinski, Med Dr.

Role: STUDY_DIRECTOR

Medical Director

Locations

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CCBR A/S

Aalborg, , Denmark

Site Status

CCBR A/S

Ballerup Municipality, , Denmark

Site Status

Y Forskning, Bispebjerg Hospital

Copenhagen NV, , Denmark

Site Status

Frederiks Hospital, Kardiologisk

Frederiksberg, , Denmark

Site Status

Kolesterollaboratoriet

Hellerup, , Denmark

Site Status

CCBR A/S

Vejle, , Denmark

Site Status

Middellaan 5

Breda, , Netherlands

Site Status

Bomanshof 8

Eindhoven, , Netherlands

Site Status

Damsterdiep 9

Groningen, , Netherlands

Site Status

Doezastraat 1

Leiden, , Netherlands

Site Status

Kamerlingh Onnesstraat 16-18

Nijmegen, , Netherlands

Site Status

Mathenesserlaan 247

Rotterdam, , Netherlands

Site Status

Reigerstraat 30

Velp, , Netherlands

Site Status

Parkdreef 142

Zoetermeer, , Netherlands

Site Status

Hospital Clinico S. Juan de Alicante

San Juan, Alicante, Spain

Site Status

Hospital Clinic i Provincial

Villaroel, Barcelona, Spain

Site Status

Hospital Universitario de Bellvitge

Barcelona, , Spain

Site Status

Hospital Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Universitario Reina Sofia

Córdoba, , Spain

Site Status

Fundacion Jimenez Diaz

Madrid, , Spain

Site Status

Hospital Clinico San Carlos

Madrid, , Spain

Site Status

Hospital Ramon y Cajal

Madrid, , Spain

Site Status

Hospital Clinico Universitario de Santiago

Santiago de Compostela, , Spain

Site Status

Hospital de Sagunto

Valencia, , Spain

Site Status

Angelholms Sjukhus, Medicinkliniken

Angelhom, , Sweden

Site Status

Sahlgrenska University Hospital, Intermedicin

Gothenburg, , Sweden

Site Status

Hjartmottagningen

Helsingborg, , Sweden

Site Status

Lakarcentrum Nyponet

Karineholm, , Sweden

Site Status

Medicinkliniken

Ludvika, , Sweden

Site Status

Hjartmottagningen

Malmo, , Sweden

Site Status

Huslakaren i Sandviken

Sandviken, , Sweden

Site Status

Narsjukhuset Sandviken, Kardiologlab, Medicin

Sandviken, , Sweden

Site Status

Hjart & Karlcenter

Södertälje, , Sweden

Site Status

Karolinska Universitetssjukhuset

Stockholm, , Sweden

Site Status

Hjarthuset AB

Varberg, , Sweden

Site Status

Countries

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Denmark Netherlands Spain Sweden

References

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Eriksson M, Budinski D, Hounslow N. Comparative efficacy of pitavastatin and simvastatin in high-risk patients: a randomized controlled trial. Adv Ther. 2011 Sep;28(9):811-23. doi: 10.1007/s12325-011-0056-7. Epub 2011 Aug 25.

Reference Type DERIVED
PMID: 21874538 (View on PubMed)

Other Identifiers

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NK-104-304

Identifier Type: -

Identifier Source: org_study_id

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