We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00309777
First Posted: April 3, 2006
Last Update Posted: January 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kowa Research Europe
  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
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

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 ]

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

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 Submitted: November 11, 2005
First Posted: April 3, 2006
Results First Submitted: August 26, 2009
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