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

This study has been completed.
Information provided by:
Kowa Research Europe Identifier:
First received: February 10, 2006
Last updated: January 25, 2010
Last verified: January 2010
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.

Condition Intervention Phase
Drug: Pitavastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Long-Term (1 Year) Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

Resource links provided by NLM:

Further study details as provided by Kowa Research Europe:

Primary Outcome Measures:
  • Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline to 52 Weeks ]

Secondary Outcome Measures:
  • Change From Baseline in Total Cholesterol [ Time Frame: Baseline to 52 weeks ]

Enrollment: 1355
Study Start Date: July 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pitavastatin 4 mg QD
Pitavastatin 4 mg once daily
Drug: Pitavastatin
Pitavastatin 4 mg once daily

Detailed Description:
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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00325780

  Show 186 Study Locations
Sponsors and Collaborators
Kowa Research Europe
Study Director: Dragos Budinski, Med Dr. Medical Director
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dragos Budinski, MD, Kowa Research Europe Identifier: NCT00325780     History of Changes
Other Study ID Numbers: NK-104-307
Study First Received: February 10, 2006
Results First Received: August 26, 2009
Last Updated: January 25, 2010

Keywords provided by Kowa Research Europe:
Hypercholesterolemia or combined dyslipidemia

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents processed this record on May 25, 2017