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Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

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ClinicalTrials.gov Identifier: NCT00309777
Recruitment Status : Completed
First Posted : April 3, 2006
Results First Posted : December 16, 2009
Last Update Posted : January 12, 2010
Sponsor:
Information provided by:
Kowa Research Europe

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 857 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
Study Start Date : September 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine


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

Active Comparator: Simvastatin 20 mg
Simvastatin 20 mg once daily
Drug: Simvastatin
Simvastatin once daily

Experimental: Pitavastatin 4 mg
Pitavastatin 4 mg once daily
Drug: Pitavastatin
Pitavastatin once daily

Active Comparator: Simvastatin 40 mg
Simvastatn 40 mg once daily
Drug: Simvastatin
Simvastatin once daily




Primary Outcome Measures :
  1. Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks [ Time Frame: Baseline to 12 weeks ]

Secondary Outcome Measures :
  1. National Cholesterol Education Program (NCEP) LDL-C Target Attainment [ Time Frame: 12 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT00309777


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Neil Hounslow, MD, Kowa Research Europe, Ltd.
ClinicalTrials.gov Identifier: NCT00309777     History of Changes
Other Study ID Numbers: NK-104-302
EudraCT number 2005-001033-15
First Posted: April 3, 2006    Key Record Dates
Results First Posted: December 16, 2009
Last Update Posted: January 12, 2010
Last Verified: January 2010

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

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