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

Primary Purpose

Hypercholesterolemia, Dyslipidemias

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pitavastatin
Sponsored by
Kowa Research Europe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring pitavastatin, hypercholesterolemia, combined dyslipidemia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Copenhagen University Hospital
  • Medical Center
  • CCBR A/S
  • Kardiologische Gemeinschaftspraxis Prof. Reifart
  • Praxis Dr. Boenninghoff
  • Klinische Forschung Berlin Mitte
  • GWT-TUK GmbH, Zentrum fur Klinische Studien
  • Gemeinschaftspraxis Dr. Krause, Th. Menke
  • Klinische Forschung Hamburg
  • Innere Medizin I/Medizinische Klinik
  • Gemeinschaftspraxis H. Holz Dr. Med, K. W. Klingl
  • ZET-Studien GmbH Leipzig
  • Internistische Gemeinschaftspraxis
  • Praxis Dr. Wachter
  • Gemeinschaftspraxis Melcherstaette
  • Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
  • Praxisgemeinschaft im Kleinen Biergrund
  • Gemeinschaftspraxis Drs. Mockesch
  • Intermed Institud Fur Klinische Forschung und Arzn
  • Gemeinschaftspraxis Dr. Emden, Frank Drewes
  • Department of Internal Medicine, Soroka Medical Center
  • Department of Internal Medicine A, Rambal Medical Center
  • Department of Internal Medicine, Wolfson Medical Center
  • Center for Research, Hadassah University Hospital
  • Meir Hospital
  • Department of Medicine, Hadassah Medical Center
  • Department of Internal Medicine, Rivka Sieff Medical Center
  • Institute of Metabolic Diseases
  • Institute of Lipid & Atherosclerosis Research
  • Andromed Breda
  • Andromed Noord
  • Vasculair Onderzoek Centrum Hoorn
  • Andromed Leiden
  • Andromed Nijmegen
  • Andromed Rotterdam
  • Albert Schweitzer Ziekenhuis
  • Rivierenland Tiel
  • Andromed Oost
  • Andromed Zoetermeer
  • Oldfield Surgery
  • St James's Surgery
  • The Pulteney Practice
  • Birmingham Clinical Research Centre
  • Stonehill Medical Center
  • Chorley Clinical Research Centre
  • Saltash Health Center
  • Gomersal Lane Surgery
  • Townhead Research
  • Crosby Clinical Research Centre
  • The Symons Medical Center
  • Manchester Clinical Research Centre
  • Greenwood Medical Center
  • Reading Clinical Research Centre
  • Elm Lane Surgery
  • Brook Lane Surgery
  • Bradford Road Medical Center
  • Rowden Medical Partnership
  • The Porch Surgery
  • The Burns Medical Practice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pitavastatin 2 mg QD

Pitavastatin 4 mg QD

Arm Description

Pitavastatin 2 mg once daily

Pitavastatin 4 mg once daily

Outcomes

Primary Outcome Measures

Change From Baseline in LDL-C
percent change from baseline in low density lipoprotein-cholesterol (LDL-C)

Secondary Outcome Measures

Change From Baseline in Total Cholesterol
Percent change from baseline in total cholesterol (TC)

Full Information

First Posted
May 26, 2006
Last Updated
March 9, 2010
Sponsor
Kowa Research Europe
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1. Study Identification

Unique Protocol Identification Number
NCT00330876
Brief Title
Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
Official Title
Open-Label, Long-Term (> 1 Year) Extension Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kowa Research Europe

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Dyslipidemias
Keywords
pitavastatin, hypercholesterolemia, combined dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
545 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pitavastatin 2 mg QD
Arm Type
Experimental
Arm Description
Pitavastatin 2 mg once daily
Arm Title
Pitavastatin 4 mg QD
Arm Type
Experimental
Arm Description
Pitavastatin 4 mg once daily
Intervention Type
Drug
Intervention Name(s)
Pitavastatin
Primary Outcome Measure Information:
Title
Change From Baseline in LDL-C
Description
percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
Time Frame
Baseline to 60 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Total Cholesterol
Description
Percent change from baseline in total cholesterol (TC)
Time Frame
Baseline to 60 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dragos Budinski, MD
Organizational Affiliation
Medical Director
Official's Role
Study Director
Facility Information:
Facility Name
Copenhagen University Hospital
City
Copenhagen
Country
Denmark
Facility Name
Medical Center
City
Copenhagen
Country
Denmark
Facility Name
CCBR A/S
City
Vejle
Country
Denmark
Facility Name
Kardiologische Gemeinschaftspraxis Prof. Reifart
City
Bad Soden/Taunus
Country
Germany
Facility Name
Praxis Dr. Boenninghoff
City
Beckum
Country
Germany
Facility Name
Klinische Forschung Berlin Mitte
City
Berlin
Country
Germany
Facility Name
GWT-TUK GmbH, Zentrum fur Klinische Studien
City
Dresden
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Krause, Th. Menke
City
Goch
Country
Germany
Facility Name
Klinische Forschung Hamburg
City
Hamburg
Country
Germany
Facility Name
Innere Medizin I/Medizinische Klinik
City
Heidelberg
Country
Germany
Facility Name
Gemeinschaftspraxis H. Holz Dr. Med, K. W. Klingl
City
Lampertheim
Country
Germany
Facility Name
ZET-Studien GmbH Leipzig
City
Leipzig
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis
City
Mainz
Country
Germany
Facility Name
Praxis Dr. Wachter
City
Mannheim
Country
Germany
Facility Name
Gemeinschaftspraxis Melcherstaette
City
Melcherstaette
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
City
Messkirch
Country
Germany
Facility Name
Praxisgemeinschaft im Kleinen Biergrund
City
Offenbach/M
Country
Germany
Facility Name
Gemeinschaftspraxis Drs. Mockesch
City
Weinheim
Country
Germany
Facility Name
Intermed Institud Fur Klinische Forschung und Arzn
City
Wiesbaden
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Emden, Frank Drewes
City
Worpswede
Country
Germany
Facility Name
Department of Internal Medicine, Soroka Medical Center
City
Beersheva
Country
Israel
Facility Name
Department of Internal Medicine A, Rambal Medical Center
City
Haifa
Country
Israel
Facility Name
Department of Internal Medicine, Wolfson Medical Center
City
Holon
Country
Israel
Facility Name
Center for Research, Hadassah University Hospital
City
Jerusalem Ein Kerem
Country
Israel
Facility Name
Meir Hospital
City
Kfar Saba
Country
Israel
Facility Name
Department of Medicine, Hadassah Medical Center
City
Mount Scopus Jerusalem
Country
Israel
Facility Name
Department of Internal Medicine, Rivka Sieff Medical Center
City
Safed
Country
Israel
Facility Name
Institute of Metabolic Diseases
City
Tel Aviv
Country
Israel
Facility Name
Institute of Lipid & Atherosclerosis Research
City
Tel Hashomer
Country
Israel
Facility Name
Andromed Breda
City
Breda
Country
Netherlands
Facility Name
Andromed Noord
City
Groningen
Country
Netherlands
Facility Name
Vasculair Onderzoek Centrum Hoorn
City
Hoorn
Country
Netherlands
Facility Name
Andromed Leiden
City
Leiden
Country
Netherlands
Facility Name
Andromed Nijmegen
City
Nijmegen
Country
Netherlands
Facility Name
Andromed Rotterdam
City
Rotterdam
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis
City
Sliedrecht
Country
Netherlands
Facility Name
Rivierenland Tiel
City
Tiel
Country
Netherlands
Facility Name
Andromed Oost
City
Velp
Country
Netherlands
Facility Name
Andromed Zoetermeer
City
Zoetermeer
Country
Netherlands
Facility Name
Oldfield Surgery
City
Bath
Country
United Kingdom
Facility Name
St James's Surgery
City
Bath
Country
United Kingdom
Facility Name
The Pulteney Practice
City
Bath
Country
United Kingdom
Facility Name
Birmingham Clinical Research Centre
City
Birmingham
Country
United Kingdom
Facility Name
Stonehill Medical Center
City
Bolton
Country
United Kingdom
Facility Name
Chorley Clinical Research Centre
City
Chorley
Country
United Kingdom
Facility Name
Saltash Health Center
City
Cornwall
Country
United Kingdom
Facility Name
Gomersal Lane Surgery
City
Dronfield
Country
United Kingdom
Facility Name
Townhead Research
City
Irvine
Country
United Kingdom
Facility Name
Crosby Clinical Research Centre
City
Liverpool
Country
United Kingdom
Facility Name
The Symons Medical Center
City
Maidenhead
Country
United Kingdom
Facility Name
Manchester Clinical Research Centre
City
Manchester
Country
United Kingdom
Facility Name
Greenwood Medical Center
City
Nottingham
Country
United Kingdom
Facility Name
Reading Clinical Research Centre
City
Reading
Country
United Kingdom
Facility Name
Elm Lane Surgery
City
Sheffield
Country
United Kingdom
Facility Name
Brook Lane Surgery
City
Southampton
Country
United Kingdom
Facility Name
Bradford Road Medical Center
City
Wiltshire
Country
United Kingdom
Facility Name
Rowden Medical Partnership
City
Wiltshire
Country
United Kingdom
Facility Name
The Porch Surgery
City
Wiltshire
Country
United Kingdom
Facility Name
The Burns Medical Practice
City
Yorkshire
Country
United Kingdom

12. IPD Sharing Statement

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

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