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

Phase 3

Completed

• Conditions: Hypercholesterolemia; Dyslipidemias
• Interventions: Drug: Pitavastatin

• Registration Number: NCT00330876
• Lead Sponsor: Kowa Research Europe

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.

Study Timeline

• Study First Submitted: 2006-05-26
• Study First Submitted QC: 2006-05-26
• Study First Posted: 2006-05-29
• Study Start: 2006-06
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Results First Submitted: 2009-08-26
• Results First Submitted QC: 2009-12-11
• Results First Posted: 2010-01-18
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-09
• Last Update Posted: 2010-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 545

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pitavastatin 4 mg QD	Pitavastatin	Pitavastatin 4 mg once daily
Pitavastatin 2 mg QD	Pitavastatin	Pitavastatin 2 mg once daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in LDL-C	Baseline to 60 weeks	percent change from baseline in low density lipoprotein-cholesterol (LDL-C)

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Total Cholesterol	Baseline to 60 weeks	Percent change from baseline in total cholesterol (TC)

Trial Locations

Locations (59)

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

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