NCT00309738

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
355

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_3

Geographic Reach
4 countries

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2005

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

January 18, 2010

Completed
Last Updated

March 16, 2010

Status Verified

March 1, 2010

Enrollment Period

1.1 years

First QC Date

December 8, 2005

Results QC Date

August 26, 2009

Last Update Submit

March 9, 2010

Conditions

HypercholesterolemiaDyslipidemia

Keywords

KowaKREHypercholesterolemiacombined dyslipidemiadyslipidemiapitavastatinNK-104simvastatin

Outcome Measures

Primary Outcomes (1)

  • Percent Change From Baseline in LDL-C

    Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)

    12 weeks

Secondary Outcomes (1)

  • Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL)

    12 weeks

Study Arms (2)

Pitavastatin 4 mg QD

EXPERIMENTAL

Pitavastatin 4 mg once daily

Drug: pitavastatin

Simvastatin 40 mg QD

ACTIVE COMPARATOR

Simvastatin 40 mg once daily

Drug: simvastatin

Interventions

pitavastatinDRUG
Pitavastatin 4 mg QD
simvastatinDRUG
Simvastatin 40 mg QD

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

CCBR A/S

Aalborg, Denmark

Location

CCBR A/S

Ballerup Municipality, Denmark

Location

Y Forskning, Bispebjerg Hospital

Copenhagen NV, Denmark

Location

Frederiks Hospital, Kardiologisk

Frederiksberg, Denmark

Location

Kolesterollaboratoriet

Hellerup, Denmark

Location

CCBR A/S

Vejle, Denmark

Location

Middellaan 5

Breda, Netherlands

Location

Bomanshof 8

Eindhoven, Netherlands

Location

Damsterdiep 9

Groningen, Netherlands

Location

Doezastraat 1

Leiden, Netherlands

Location

Kamerlingh Onnesstraat 16-18

Nijmegen, Netherlands

Location

Mathenesserlaan 247

Rotterdam, Netherlands

Location

Reigerstraat 30

Velp, Netherlands

Location

Parkdreef 142

Zoetermeer, Netherlands

Location

Hospital Clinico S. Juan de Alicante

San Juan, Alicante, Spain

Location

Hospital Clinic i Provincial

Villaroel, Barcelona, Spain

Location

Hospital Universitario de Bellvitge

Barcelona, Spain

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, Spain

Location

Fundacion Jimenez Diaz

Madrid, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Ramon y Cajal

Madrid, Spain

Location

Hospital Clinico Universitario de Santiago

Santiago de Compostela, Spain

Location

Hospital de Sagunto

Valencia, Spain

Location

Angelholms Sjukhus, Medicinkliniken

Angelhom, Sweden

Location

Sahlgrenska University Hospital, Intermedicin

Gothenburg, Sweden

Location

Hjartmottagningen

Helsingborg, Sweden

Location

Lakarcentrum Nyponet

Karineholm, Sweden

Location

Medicinkliniken

Ludvika, Sweden

Location

Hjartmottagningen

Malmo, Sweden

Location

Huslakaren i Sandviken

Sandviken, Sweden

Location

Narsjukhuset Sandviken, Kardiologlab, Medicin

Sandviken, Sweden

Location

Hjart & Karlcenter

Södertälje, Sweden

Location

Karolinska Universitetssjukhuset

Stockholm, Sweden

Location

Hjarthuset AB

Varberg, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 21874538DERIVED

MeSH Terms

Conditions

HypercholesterolemiaDyslipidemias

Interventions

pitavastatinSimvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Bill Arana
Organization
Kowa Research Institute
barana@kowaus.com
919 433 1600

Study Officials

  • Dragos Budinski, Med Dr.

    Medical Director

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 8, 2005

First Posted

April 3, 2006

Study Start

September 1, 2005

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

March 16, 2010

Results First Posted

January 18, 2010

Record last verified: 2010-03

Locations

NL(8)DK(6)ES(10)SE(11)