Clinical trial NCT00330876: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Dyslipidemias
Keywords: pitavastatin
hypercholesterolemia
combined dyslipidemia
Lead sponsor: Kowa Research Europe
Sponsor class: INDUSTRY
First posted: 2006-05-29
Enrollment: 545
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change From Baseline in LDL-C
timeFrame: Baseline to 60 weeks
Secondary outcomes:
measure: Change From Baseline in Total Cholesterol
timeFrame: Baseline to 60 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
city: Copenhagen
country: Denmark
facility: Medical Center
city: Vejle
country: Denmark
facility: CCBR A/S
city: Bad Soden/Taunus
country: Germany
facility: Kardiologische Gemeinschaftspraxis Prof. Reifart
city: Beckum
country: Germany
facility: Praxis Dr. Boenninghoff
city: Berlin
country: Germany
facility: Klinische Forschung Berlin Mitte
city: Dresden
country: Germany
facility: GWT-TUK GmbH, Zentrum fur Klinische Studien
city: Goch
country: Germany
facility: Gemeinschaftspraxis Dr. Krause, Th. Menke
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg
city: Heidelberg
country: Germany
facility: Innere Medizin I/Medizinische Klinik
city: Lampertheim
country: Germany
facility: Gemeinschaftspraxis H. Holz Dr. Med, K. W. Klingl
city: Leipzig
country: Germany
facility: ZET-Studien GmbH Leipzig
city: Mainz
country: Germany
facility: Internistische Gemeinschaftspraxis
city: Mannheim
country: Germany
facility: Praxis Dr. Wachter
city: Melcherstaette
country: Germany
facility: Gemeinschaftspraxis Melcherstaette
city: Messkirch
country: Germany
facility: Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
city: Offenbach/M
country: Germany
facility: Praxisgemeinschaft im Kleinen Biergrund
city: Weinheim
country: Germany
facility: Gemeinschaftspraxis Drs. Mockesch
city: Wiesbaden
country: Germany
facility: Intermed Institud Fur Klinische Forschung und Arzn
city: Worpswede
country: Germany
facility: Gemeinschaftspraxis Dr. Emden, Frank Drewes
city: Beersheva
country: Israel
facility: Department of Internal Medicine, Soroka Medical Center
city: Haifa
country: Israel
facility: Department of Internal Medicine A, Rambal Medical Center
city: Holon
country: Israel
facility: Department of Internal Medicine, Wolfson Medical Center
city: Jerusalem Ein Kerem
country: Israel
facility: Center for Research, Hadassah University Hospital
city: Kfar Saba
country: Israel
facility: Meir Hospital
city: Mount Scopus Jerusalem
country: Israel
facility: Department of Medicine, Hadassah Medical Center
city: Safed
country: Israel
facility: Department of Internal Medicine, Rivka Sieff Medical Center
city: Tel Aviv
country: Israel
facility: Institute of Metabolic Diseases
city: Tel Hashomer
country: Israel
facility: Institute of Lipid & Atherosclerosis Research
city: Breda
country: Netherlands
facility: Andromed Breda
city: Groningen
country: Netherlands
facility: Andromed Noord
city: Hoorn
country: Netherlands
facility: Vasculair Onderzoek Centrum Hoorn
city: Leiden
country: Netherlands
facility: Andromed Leiden
city: Nijmegen
country: Netherlands
facility: Andromed Nijmegen
city: Rotterdam
country: Netherlands
facility: Andromed Rotterdam
city: Sliedrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Tiel
country: Netherlands
facility: Rivierenland Tiel
city: Velp
country: Netherlands
facility: Andromed Oost
city: Zoetermeer
country: Netherlands
facility: Andromed Zoetermeer
city: Bath
country: United Kingdom
facility: Oldfield Surgery
city: Bath
country: United Kingdom
facility: St James's Surgery
city: Bath
country: United Kingdom
facility: The Pulteney Practice
city: Birmingham
country: United Kingdom
facility: Birmingham Clinical Research Centre
city: Bolton
country: United Kingdom
facility: Stonehill Medical Center
city: Chorley
country: United Kingdom
facility: Chorley Clinical Research Centre
city: Cornwall
country: United Kingdom
facility: Saltash Health Center
city: Dronfield
country: United Kingdom
facility: Gomersal Lane Surgery
city: Irvine
country: United Kingdom
facility: Townhead Research
city: Liverpool
country: United Kingdom
facility: Crosby Clinical Research Centre
city: Maidenhead
country: United Kingdom
facility: The Symons Medical Center
city: Manchester
country: United Kingdom
facility: Manchester Clinical Research Centre
city: Nottingham
country: United Kingdom
facility: Greenwood Medical Center
city: Reading
country: United Kingdom
facility: Reading Clinical Research Centre
city: Sheffield
country: United Kingdom
facility: Elm Lane Surgery
city: Southampton
country: United Kingdom
facility: Brook Lane Surgery
city: Wiltshire
country: United Kingdom
facility: Bradford Road Medical Center
city: Wiltshire
country: United Kingdom
facility: Rowden Medical Partnership
city: Wiltshire
country: United Kingdom
facility: The Porch Surgery
city: Yorkshire
country: United Kingdom
facility: The Burns Medical Practice
Study officials:
affiliation: Medical Director
name: Dragos Budinski, MD
role: STUDY_DIRECTOR
References: