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

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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:
Kowa Research Europe

February 10, 2006
May 15, 2006
August 26, 2009
January 18, 2010
February 2, 2010
July 2006
November 2007   (Final data collection date for primary outcome measure)
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline to 52 Weeks ]
Change from baseline in LDL-C
Complete list of historical versions of study NCT00325780 on ClinicalTrials.gov Archive Site
Change From Baseline in Total Cholesterol [ Time Frame: Baseline to 52 weeks ]
  • Changes in lipid and lipoprotein measures
  • Safety and tolerability
Not Provided
Not Provided
 
Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
Open-Label, Long-Term (1 Year) 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.
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.
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hypercholesterolemia
  • Dyslipidemia
Drug: Pitavastatin
Pitavastatin 4 mg once daily
Experimental: Pitavastatin 4 mg QD
Pitavastatin 4 mg once daily
Intervention: Drug: Pitavastatin
Ose L, Budinski D, Hounslow N, Arneson V. Long-term treatment with pitavastatin is effective and well tolerated by patients with primary hypercholesterolemia or combined dyslipidemia. Atherosclerosis. 2010 May;210(1):202-8. doi: 10.1016/j.atherosclerosis.2009.12.009. Epub 2009 Dec 11. Erratum in: Atherosclerosis. 2010 Oct;212(2):704.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1355
November 2007
November 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Finland,   Germany,   India,   Israel,   Italy,   Netherlands,   Norway,   Poland,   Russian Federation,   Spain,   Sweden,   United Kingdom
 
 
NCT00325780
NK-104-307
2005-001112-41
No
Not Provided
Not Provided
Dragos Budinski, MD, Kowa Research Europe
Kowa Research Europe
Not Provided
Study Director: Dragos Budinski, Med Dr. Medical Director
Kowa Research Europe
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP