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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00325780
Recruitment Status : Completed
First Posted : May 15, 2006
Results First Posted : January 18, 2010
Last Update Posted : February 2, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Hypercholesterolemia Dyslipidemia Drug: Pitavastatin Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1355 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2006
Primary Completion Date : November 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Pitavastatin 4 mg QD
Pitavastatin 4 mg once daily
Drug: Pitavastatin
Pitavastatin 4 mg once daily


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325780


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dragos Budinski, MD, Kowa Research Europe
ClinicalTrials.gov Identifier: NCT00325780     History of Changes
Other Study ID Numbers: NK-104-307
2005-001112-41
First Posted: May 15, 2006    Key Record Dates
Results First Posted: January 18, 2010
Last Update Posted: February 2, 2010
Last Verified: January 2010

Keywords provided by Kowa Research Europe:
Kowa
Hypercholesterolemia
dyslipidemia
pitavastatin
NK-104
Hypercholesterolemia or combined dyslipidemia

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pitavastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents