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NCT Number: NCT00325780

Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

This study is a long-term follow-up protocol for patients who participated in study NK-104-3.01EU or study NK-104-3.02EU.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Copenhagen University Hospital, Copenhagen, Denmark

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About this study

Patients from the NK-104-3.01EU and NK-104-3.02EU studies will continue to receive either pitavastatin or the comparator statin for 1 year.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients have completed 12 weeks of treatment in Study NK-104-301 (NCT00249249) or NK-104-302 (NCT00309777)
  • Patients who have not developed any treatment emergent and, in the opinion of the investigator, related adverse event (AE) of clinical significance where the investigator is uncomfortable with continuing the patient on therapy with pitavastatin.
  • Patients who have been following a fat and cholesterol restrictive diet.

Exclusion criteria

  • Any conditions which may cause secondary dyslipidemia should be reassessed at the beginning of the follow-up study.
  • Uncontrolled diabetes mellitus should be reassessed at the beginning of the follow-up study.
  • Abnormal pancreatic, liver, or renal function
  • Abnormal serum ALAT/SGPT/ALT, ASAT/SGOT/AST, or creatine kinase (CK) above the pre-specified level
  • Significant heart disease

Treatment and study plan

Pitavastatin

Drug

Pitavastatin 4 mg once daily

Primary outcomes

  1. Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)

    Time frame: Baseline to 52 Weeks

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

Secondary outcomes

  1. Change From Baseline in Total Cholesterol

    Time frame: Baseline to 52 weeks

    Mean percent change from baseline in total cholesterol

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 Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 15, 2006
Registry last updated
Feb 2, 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.

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