Skip to main content
OpenTrials
Completed

NCT Number: NCT00330876

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Copenhagen University Hospital, Copenhagen, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pitavastatin

Drug

Primary outcomes

  1. Change From Baseline in LDL-C

    Time frame: Baseline to 60 weeks

    percent change from baseline in low density lipoprotein-cholesterol (LDL-C)

Secondary outcomes

  1. Change From Baseline in Total Cholesterol

    Time frame: Baseline to 60 weeks

    Percent change from baseline in total cholesterol (TC)

Sponsors and collaborators

Lead sponsor

Kowa Research Europe

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 29, 2006
Registry last updated
Mar 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.