NCT00330876

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 545 (actual)
• Sponsor: Kowa Research Europe · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Pitavastatin

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2006-05-29
• Last updated: 2010-03-16
• Results posted: 2010-01-18

Locations

59 sites across 5 countries: Denmark, Germany, Israel, Netherlands, United Kingdom