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Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

This study has been completed.
Sponsor:
Information provided by:
Kowa Research Europe
ClinicalTrials.gov Identifier:
NCT00309777
First received: November 11, 2005
Last updated: January 7, 2010
Last verified: January 2010
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Kowa Research Europe:

Primary Outcome Measures:
  • Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • National Cholesterol Education Program (NCEP) LDL-C Target Attainment [ Time Frame: 12 week ] [ Designated as safety issue: No ]

Enrollment: 857
Study Start Date: September 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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

No publications provided by Kowa Research Europe

Additional 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
Study First Received: November 11, 2005
Results First Received: August 26, 2009
Last Updated: January 7, 2010
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

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

ClinicalTrials.gov processed this record on May 23, 2013