Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors

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. Identifier: NCT00344175
Recruitment Status : Completed
First Posted : June 26, 2006
Results First Posted : January 18, 2010
Last Update Posted : February 2, 2010
Information provided by:
Kowa Research Europe

Brief Summary:
This is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study NK-104-304.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dyslipidemia Coronary Heart Disease Drug: pitavastatin Drug: simvastatin Phase 3

Detailed Description:
This is a sixteen-week, double-blind, active controlled, follow-on and 28 week single blind extension study for patients who participated in NK-104-304.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind follow-on Study of Pitavastatin (4mg) Versus Simvastatin (40mg and 80mg) With a Single-blind Extension of Treatment in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart Disease
Study Start Date : June 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Arm Intervention/treatment
Experimental: Pitavastatin 4 mg
Pitavastatin 4 mg once daily
Drug: pitavastatin
Active Comparator: Simvastatin 40mg/80mg
Simvastatin 40 mg or 80 mg once daily
Drug: simvastatin

Primary Outcome Measures :
  1. Number of Patients Attaining NCEP LDL-C Target at Week 16 [ Time Frame: 16 weeks ]
  2. Number of Patients Attaining NCEP LDL-C Target at Week 44 [ Time Frame: 44 Weeks ]

Secondary Outcome Measures :
  1. Percent Change From Baseline in LDL-C [ Time Frame: Baseline to 44 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Completed NK-104-304 (NCT 00309738)
  • Hypercholesterolemia or combined dyslipidemia
  • 2 or more risk factors for coronary heart disease (CHD)

Exclusion Criteria:

  • Withdrawn or terminated from NK-104-304 (00309738)

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 identifier (NCT number): NCT00344175

Y Forskning, Bispebjerg Hospital
Copenhagen Nv, Denmark
Frederiks Hospital, Kardiologisk
Frederiksberg, Denmark
Hellerup, Denmark
Vejle, Denmark
Middellaan 5
Breda, Netherlands
Bomanshof 8
Eindhoven, Netherlands
Damsterdiep 9
Groningen, Netherlands
Doezastraat 1
Leiden, Netherlands
Kamerlingh Onnesstraat 16-18
Nijmegen, Netherlands
Mathenesserlaan 247
Rotterdam, Netherlands
Reigerstraat 30
Velp, Netherlands
Parkdreef 142
Zoetermeer, Netherlands
Hospital Clinico S. Juan de Alicante
San Juan, Alicante, Spain
Hospital Universitario Reina Sofia
Cordoba, Spain
Hospital Ramon y Cajal
Madrid, Spain, 28000
Fundacion Jimenez Diaz
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Spain
Angelholms Sjukhus, Medicinkliniken
Angelhom, Sweden
Sahlgrenska University Hospital, Intermedicin
Gothenburg, Sweden
Helsingborg, Sweden
Lakarcentrum Nyponet
Karineholm, Sweden
Ludvika, Sweden
Huslakaren i Sandviken
Sandviken, Sweden
Narsjukhuset Sandviken, Kardiologlab, Medicin
Sandviken, Sweden
Hjart & Karlcenter
Sodertalje, Sweden
Karolinska Universitetssjukhuset
Stockholm, Sweden
Hjarthuset AB
Varberg, Sweden
Sponsors and Collaborators
Kowa Research Europe
Study Director: Dragos Budinski, MD Kowa Research Europe

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dragos Budinski, Kowa Research Europe Identifier: NCT00344175     History of Changes
Other Study ID Numbers: NK-104-309
First Posted: June 26, 2006    Key Record Dates
Results First Posted: January 18, 2010
Last Update Posted: February 2, 2010
Last Verified: January 2010

Keywords provided by Kowa Research Europe:
2 or more risk factors for coronary heart disease
combined dyslipidemia

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Arterial Occlusive Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors