Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors

January 25, 2010 updated by: Kowa Research Europe

Double-blind follow-on Study of Pitavastatin (4mg) Versus Simvastatin (40mg and 80mg) With a Single-blind Extension of Treatment in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

178

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
      • 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
      • Cordoba, Spain
        • Hospital Universitario Reina Sofía
      • Madrid, Spain
        • Fundación Jiménez Díaz
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28000
        • Hospital Ramon y Cajal
      • Santiago de Compostela, Spain
        • Hospital Clínico Universitario de Santiago
    • Alicante
      • San Juan, Alicante, Spain
        • Hospital Clinico S. Juan de Alicante
  • Sweden
      • Angelhom, Sweden
        • Angelholms Sjukhus, Medicinkliniken
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital, Intermedicin
      • Helsingborg, Sweden
        • Hjärtmottagningen
      • Karineholm, Sweden
        • Lakarcentrum Nyponet
      • Ludvika, Sweden
        • Medicinkliniken
      • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Withdrawn or terminated from NK-104-304 (00309738)

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
Pitavastatin 4 mg once daily
Drug: pitavastatin
Active Comparator: Simvastatin 40mg/80mg
Simvastatin 40 mg or 80 mg once daily
Drug: simvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Attaining NCEP LDL-C Target at Week 16
Time Frame: 16 weeks
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
Time Frame: 44 Weeks
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 Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in LDL-C
Time Frame: Baseline to 44 weeks
Baseline to 44 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, MD, Kowa Research Europe

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

June 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

June 22, 2006

First Submitted That Met QC Criteria

June 23, 2006

First Posted (Estimate)

June 26, 2006

Study Record Updates

Last Update Posted (Estimate)

February 2, 2010

Last Update Submitted That Met QC Criteria

January 25, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK-104-309

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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