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

NCT ID: NCT00330876

Last Updated: 2010-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 545 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2007-12-31

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.

Conditions

Hypercholesterolemia; Dyslipidemias

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pitavastatin 2 mg QD

Pitavastatin 2 mg once daily

Group Type: EXPERIMENTAL

Pitavastatin

Intervention Type: DRUG

Pitavastatin 4 mg QD

Pitavastatin 4 mg once daily

Group Type: EXPERIMENTAL

Pitavastatin

Intervention Type: DRUG

Interventions

Pitavastatin

Intervention Type: DRUG

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kowa Research Europe

INDUSTRY

Sponsor Role: lead

Responsible Party

Kowa Research Europe

Principal Investigators

Dragos Budinski, MD

Role: STUDY_DIRECTOR

Medical Director

Locations

Copenhagen University Hospital

Copenhagen, , Denmark

Medical Center

Copenhagen, , Denmark

CCBR A/S

Vejle, , Denmark

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, , Germany

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 Litwinsky, , Israel

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, , Netherlands

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, , United Kingdom

Countries

Denmark; Germany; Israel; Netherlands; United Kingdom

Other Identifiers

NK-104-308EU

Identifier Type: -

Identifier Source: org_study_id