Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

March 9, 2010 updated by: Kowa Research Europe

Open-Label, Long-Term (> 1 Year) Extension Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

This is an open-label extension study of NK-104-306 (NCT00257686) for elderly patients with hypercholesterolemia or combined dyslipidemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was an open-label study of 60 weeks duration in elderly patients (≥65 years) with primary hypercholesterolemia or combined dyslipidemia who completed the 12 week treatment in study NK-104-306 and who met the inclusion/exclusion criteria. Patients who qualified started open-label treatment with pitavastatin 2 mg QD. The dose of pitavastatin could be increased to 4 mg QD after at least 8 weeks of treatment at 2 mg QD, in patients who failed to attain their LDL-C target.

Study Type

Interventional

Enrollment (Actual)

545

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, Denmark
        • Copenhagen University Hospital
      • Copenhagen, Denmark
        • Medical Center
      • Vejle, Denmark
        • CCBR A/S
  • Germany
      • Bad Soden/Taunus, Germany
        • Kardiologische Gemeinschaftspraxis Prof. Reifart
      • Beckum, Germany
        • Praxis Dr. Boenninghoff
      • Berlin, Germany
        • Klinische Forschung Berlin Mitte
      • Dresden, Germany
        • GWT-TUK GmbH, Zentrum fur Klinische Studien
      • Goch, Germany
        • Gemeinschaftspraxis Dr. Krause, Th. Menke
      • Hamburg, Germany
        • Klinische Forschung Hamburg
      • Heidelberg, Germany
        • Innere Medizin I/Medizinische Klinik
      • Lampertheim, Germany
        • Gemeinschaftspraxis H. Holz Dr. Med, K. W. Klingl
      • Leipzig, Germany
        • ZET-Studien GmbH Leipzig
      • Mainz, Germany
        • Internistische Gemeinschaftspraxis
      • Mannheim, Germany
        • Praxis Dr. Wachter
      • Melcherstaette, Germany
        • Gemeinschaftspraxis Melcherstaette
      • Messkirch, Germany
        • Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
      • Offenbach/M, Germany
        • Praxisgemeinschaft im Kleinen Biergrund
      • Weinheim, Germany
        • Gemeinschaftspraxis Drs. Mockesch
      • Wiesbaden, Germany
        • Intermed Institud fur Klinische Forschung und Arzn
      • Worpswede, Germany
        • Gemeinschaftspraxis Dr. Emden, Frank Drewes
  • Israel
      • Beersheva, Israel
        • Department of Internal Medicine, Soroka Medical Center
      • Haifa, Israel
        • Department of Internal Medicine A, Rambal Medical Center
      • Holon, Israel
        • Department of Internal Medicine, Wolfson Medical Center
      • Jerusalem Ein Kerem, Israel
        • Center for Research, Hadassah University Hospital
      • Kfar Saba, Israel
        • Meir Hospital
      • Mount Scopus Jerusalem, Israel
        • Department of Medicine, Hadassah Medical Center
      • Safed, Israel
        • Department of Internal Medicine, Rivka Sieff Medical Center
      • Tel Aviv, Israel
        • Institute of Metabolic Diseases
      • Tel Hashomer, Israel
        • Institute of Lipid & Atherosclerosis Research
  • Netherlands
      • Breda, Netherlands
        • Andromed Breda
      • Groningen, Netherlands
        • Andromed Noord
      • Hoorn, Netherlands
        • Vasculair Onderzoek Centrum Hoorn
      • Leiden, Netherlands
        • Andromed Leiden
      • Nijmegen, Netherlands
        • Andromed Nijmegen
      • Rotterdam, Netherlands
        • Andromed Rotterdam
      • Sliedrecht, Netherlands
        • Albert Schweitzer Ziekenhuis
      • Tiel, Netherlands
        • Rivierenland Tiel
      • Velp, Netherlands
        • Andromed Oost
      • Zoetermeer, Netherlands
        • Andromed Zoetermeer
  • United Kingdom
      • Bath, United Kingdom
        • Oldfield Surgery
      • Bath, United Kingdom
        • St James's Surgery
      • Bath, United Kingdom
        • The Pulteney Practice
      • Birmingham, United Kingdom
        • Birmingham Clinical Research Centre
      • Bolton, United Kingdom
        • Stonehill Medical Center
      • Chorley, United Kingdom
        • Chorley Clinical Research Centre
      • Cornwall, United Kingdom
        • Saltash Health Center
      • Dronfield, United Kingdom
        • Gomersal Lane Surgery
      • Irvine, United Kingdom
        • Townhead Research
      • Liverpool, United Kingdom
        • Crosby Clinical Research Centre
      • Maidenhead, United Kingdom
        • The Symons Medical Center
      • Manchester, United Kingdom
        • Manchester Clinical Research Centre
      • Nottingham, United Kingdom
        • Greenwood Medical Center
      • Reading, United Kingdom
        • Reading Clinical Research Centre
      • Sheffield, United Kingdom
        • Elm Lane Surgery
      • Southampton, United Kingdom
        • Brook Lane Surgery
      • Wiltshire, United Kingdom
        • Bradford Road Medical Center
      • Wiltshire, United Kingdom
        • Rowden Medical Partnership
      • Wiltshire, United Kingdom
        • The Porch Surgery
      • Yorkshire, United Kingdom
        • The Burns Medical Practice

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Greater than or equal to 65 years of age
  • Primary hypercholesterolemia
  • Combined dyslipidemia
  • Completed study NK-104-306 (NCT00257686)

Exclusion Criteria:

  • Failed to complete study NK-104-306(NCT00257686)

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pitavastatin 4 mg QD
Pitavastatin 4 mg once daily
Drug: Pitavastatin
Experimental: Pitavastatin 2 mg QD
Pitavastatin 2 mg once daily
Drug: Pitavastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in LDL-C
Time Frame: Baseline to 60 weeks
percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
Baseline to 60 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Total Cholesterol
Time Frame: Baseline to 60 weeks
Percent change from baseline in total cholesterol (TC)
Baseline to 60 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, Medical Director

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)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

May 26, 2006

First Submitted That Met QC Criteria

May 26, 2006

First Posted (Estimate)

May 29, 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-104-308EU

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.

Clinical Trials on Dyslipidemias

Clinical Trials on Pitavastatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe