NCT00344175

Brief Summary

This is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study NK-104-304.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
178

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_3

Geographic Reach
4 countries

28 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

June 1, 2006

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

January 18, 2010

Completed
Last Updated

February 2, 2010

Status Verified

January 1, 2010

Enrollment Period

1.2 years

First QC Date

June 22, 2006

Results QC Date

September 1, 2009

Last Update Submit

January 25, 2010

Conditions

HypercholesterolemiaDyslipidemiaCoronary Heart Disease

Keywords

hypercholesterolemiadyslipidemiaCHDpitavastatinsimvastatin2 or more risk factors for coronary heart diseasecombined dyslipidemia

Outcome Measures

Primary Outcomes (2)

  • Number of Patients Attaining NCEP LDL-C Target at Week 16

    Number of patients attaining the National Cholesterol Education Program (NCEP) LDL-C target at Week 16. According to NCEP criteria the target LDL-C is 100 mg/dL.

    16 weeks

  • Number of Patients Attaining NCEP LDL-C Target at Week 44

    Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at Week 44. According to NCEP criteria the target LDL-C is 100 mg/dL.

    44 Weeks

Secondary Outcomes (1)

  • Percent Change From Baseline in LDL-C

    Baseline to 44 weeks

Study Arms (2)

Pitavastatin 4 mg

EXPERIMENTAL

Pitavastatin 4 mg once daily

Drug: pitavastatin

Simvastatin 40mg/80mg

ACTIVE COMPARATOR

Simvastatin 40 mg or 80 mg once daily

Drug: simvastatin

Interventions

pitavastatinDRUG
Pitavastatin 4 mg
simvastatinDRUG
Simvastatin 40mg/80mg

Eligibility Criteria

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

You may qualify if:

  • Completed NK-104-304 (NCT 00309738)
  • Hypercholesterolemia or combined dyslipidemia
  • or more risk factors for coronary heart disease (CHD)

You may not qualify if:

  • Withdrawn or terminated from NK-104-304 (00309738)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

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 Universitario Reina Sofia

Córdoba, Spain

Location

Hospital Ramon y Cajal

Madrid, 28000, Spain

Location

Fundacion Jimenez Diaz

Madrid, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Clinico Universitario de Santiago

Santiago de Compostela, 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

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. Long-term efficacy of pitavastatin versus simvastatin. Adv Ther. 2011 Sep;28(9):799-810. doi: 10.1007/s12325-011-0057-6. Epub 2011 Aug 25.

    PMID: 21874537DERIVED

MeSH Terms

Conditions

HypercholesterolemiaDyslipidemiasCoronary Disease

Interventions

pitavastatinSimvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular 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, MD

    Kowa Research Europe

    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

June 22, 2006

First Posted

June 26, 2006

Study Start

June 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

February 2, 2010

Results First Posted

January 18, 2010

Record last verified: 2010-01

Locations

DK(4)SE(10)NL(8)ES(6)