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Study of Pitavastatin in Elderly 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: NCT00330876
Recruitment Status : Completed
First Posted : May 29, 2006
Results First Posted : January 18, 2010
Last Update Posted : March 16, 2010
Sponsor:
Information provided by:
Kowa Research Europe

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

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dyslipidemias Drug: Pitavastatin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 545 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Long-Term (> 1 Year) Extension Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
Study Start Date : June 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pitavastatin 2 mg QD
Pitavastatin 2 mg once daily
Drug: Pitavastatin
Experimental: Pitavastatin 4 mg QD
Pitavastatin 4 mg once daily
Drug: Pitavastatin



Primary Outcome Measures :
  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 Outcome Measures :
  1. Change From Baseline in Total Cholesterol [ Time Frame: Baseline to 60 weeks ]
    Percent change from baseline in total cholesterol (TC)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT00330876


Locations
Show Show 59 study locations
Sponsors and Collaborators
Kowa Research Europe
Investigators
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Study Director: Dragos Budinski, MD Medical Director
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Responsible Party: Neil Hounslow, Kowa Research Europe
ClinicalTrials.gov Identifier: NCT00330876    
Other Study ID Numbers: NK-104-308EU
First Posted: May 29, 2006    Key Record Dates
Results First Posted: January 18, 2010
Last Update Posted: March 16, 2010
Last Verified: March 2010
Keywords provided by Kowa Research Europe:
pitavastatin
hypercholesterolemia
combined dyslipidemia
Additional relevant MeSH terms:
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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