Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

March 9, 2010 updated by: Kowa Research Europe

Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

355

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark
        • CCBR A/S
      • Ballerup, Denmark
        • CCBR A/S
      • Copenhagen NV, Denmark
        • Y Forskning, Bispebjerg Hospital
      • Frederiksberg, Denmark
        • Frederiks Hospital, Kardiologisk
      • Hellerup, Denmark
        • Kolesterollaboratoriet
      • Vejle, Denmark
        • CCBR A/S
  • Netherlands
      • Breda, Netherlands
        • Middellaan 5
      • Eindhoven, Netherlands
        • Bomanshof 8
      • Groningen, Netherlands
        • Damsterdiep 9
      • Leiden, Netherlands
        • Doezastraat 1
      • Nijmegen, Netherlands
        • Kamerlingh Onnesstraat 16-18
      • Rotterdam, Netherlands
        • Mathenesserlaan 247
      • Velp, Netherlands
        • Reigerstraat 30
      • Zoetermeer, Netherlands
        • Parkdreef 142
  • Spain
      • Barcelona, Spain
        • Hospital Universitario de Bellvitge
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Cordoba, Spain
        • Hospital Universitario Reina Sofía
      • Madrid, Spain
        • Hospital Ramón y Cajal
      • Madrid, Spain
        • Fundacion Jimenez Diaz
      • Madrid, Spain
        • Hospital Clínico San Carlos
      • Santiago de Compostela, Spain
        • Hospital Clinico Universitario de Santiago
      • Valencia, Spain
        • Hospital de Sagunto
    • Alicante
      • San Juan, Alicante, Spain
        • Hospital Clinico S. Juan de Alicante
    • Barcelona
      • Villaroel, Barcelona, Spain
        • Hospital Clinic I Provincial
  • Sweden
      • Angelhom, Sweden
        • Angelholms Sjukhus, Medicinkliniken
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital, Intermedicin
      • Helsingborg, Sweden
        • Hjärtmottagningen
      • Karineholm, Sweden
        • Lakarcentrum Nyponet
      • Ludvika, Sweden
        • Medicinkliniken
      • Malmo, Sweden
        • Hjärtmottagningen
      • Sandviken, Sweden
        • Huslakaren i Sandviken
      • Sandviken, Sweden
        • Narsjukhuset Sandviken, Kardiologlab, Medicin
      • Sodertalje, Sweden
        • Hjart & Karlcenter
      • Stockholm, Sweden
        • Karolinska Universitetssjukhuset
      • Varberg, Sweden
        • Hjarthuset AB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pitavastatin 4 mg QD
Pitavastatin 4 mg once daily
Drug: pitavastatin
Active Comparator: Simvastatin 40 mg QD
Simvastatin 40 mg once daily
Drug: simvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in LDL-C
Time Frame: 12 weeks
Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL)
Time Frame: 12 weeks
Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (< 160 mg/dL)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kowa Research Europe

Investigators

  • Study Director: Dragos Budinski, Med Dr., Medical Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

December 8, 2005

First Submitted That Met QC Criteria

March 31, 2006

First Posted (Estimate)

April 3, 2006

Study Record Updates

Last Update Posted (Estimate)

March 16, 2010

Last Update Submitted That Met QC Criteria

March 9, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK-104-304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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