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Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin
This study has been completed.
Sponsored by: Kowa Research Europe
Information provided by: Kowa Research Europe
ClinicalTrials.gov Identifier: NCT00309777
  Purpose

The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.


Condition Intervention Phase
Hypercholesterolemia
Dyslipidemia
 Drug: Pitavastatin
Drug: Simvastatin
 Phase III

Genetics Home Reference related topics: hypercholesterolemia
MedlinePlus related topics: Cholesterol
Drug Information available for: Simvastatin Pitavastatin NK 104
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

Further study details as provided by Kowa Research Europe:

Primary Outcome Measures:
  • Percent change from baseline low density lipoprotein-cholesterol (LDL-C)

Secondary Outcome Measures:
  • Changes in lipid and lipoprotein measures from baseline
  • Safety and tolerability

Estimated Enrollment: 800
Study Start Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females (18-75 years)
  • Must have been following a restrictive diet
  • Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion Criteria:

  • Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia;
  • Conditions which may cause secondary dyslipidemia.
  • Uncontrolled diabetes mellitus (by hemoglobin A1c [HbA1c] > 8%)
  • Abnormal serum creatine kinase (CK) above the pre-specified level
  • Abnormal pancreatic, liver or renal function
  • Significant heart disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309777

  Show 42 Study Locations
Sponsors and Collaborators
Kowa Research Europe
Investigators
Study Director: Dragos Budinski, Med Dr. Medical Director
  More Information

Study ID Numbers: NK-104-302, EudraCT number 2005-001033-15
Study First Received: November 11, 2005
Last Updated: October 23, 2008
ClinicalTrials.gov Identifier: NCT00309777  
Health Authority: Italy: Ministry of Health;   Russia: Pharmacological Committee, Ministry of Health;   Finland: Ethics Committee;   United Kingdom: National Health Service;   Norway: Norwegian Medicines Agency

Keywords provided by Kowa Research Europe:
hypercholesterolemia
kowa
dyslipidemia
 pitavastatin
NK-104
Primary Hypercholesterolemia or Combined Dyslipidemia

Study placed in the following topic categories:
Metabolic Diseases
Hyperlipidemias
NK 104
Simvastatin
 Metabolic disorder
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
 Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009



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