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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00330876
• Other study ID #: NK-104-308EU
• Status: Completed
• Phase: Phase 3
• First received: May 26, 2006
• Last updated: March 9, 2010
• Start date: June 2006
• Est. completion date: December 2007

Study information

• Verified date: March 2010
• Source: Kowa Research Europe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsGermany: Federal Institute for Drugs and Medical DevicesNetherlands: Independent Ethics CommitteeUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 545
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia

Intervention

Drug:
• Pitavastatin

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Europe

Countries where clinical trial is conducted

Denmark,  Germany,  Israel,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in LDL-C	percent change from baseline in low density lipoprotein-cholesterol (LDL-C)	Baseline to 60 weeks	No
Secondary	Change From Baseline in Total Cholesterol	Percent change from baseline in total cholesterol (TC)	Baseline to 60 weeks	No