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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 27, 2014