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

This study has been completed.
Sponsor:
Information provided by:
Kowa Research Europe
ClinicalTrials.gov Identifier:
NCT00344175
First received: June 22, 2006
Last updated: January 25, 2010
Last verified: January 2010
  Purpose

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


Condition Intervention Phase
Hypercholesterolemia
Dyslipidemia
Coronary Heart Disease
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, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Kowa Research Europe:

Primary Outcome Measures:
  • Number of Patients Attaining NCEP LDL-C Target at Week 16 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Number of Patients Attaining NCEP LDL-C Target at Week 44 [ Time Frame: 44 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent Change From Baseline in LDL-C [ Time Frame: Baseline to 44 weeks ] [ Designated as safety issue: No ]

Enrollment: 178
Study Start Date: June 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT00344175

Locations
Denmark
Y Forskning, Bispebjerg Hospital
Copenhagen Nv, Denmark
Frederiks Hospital, Kardiologisk
Frederiksberg, Denmark
Kolesterollaboratoriet
Hellerup, Denmark
CCBR A/S
Vejle, Denmark
Netherlands
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
Spain
Hospital Clinico S. Juan de Alicante
San Juan, Alicante, Spain
Hospital Universitario Reina Sofia
Cordoba, Spain
Fundacion Jimenez Diaz
Madrid, Spain
Hospital Ramon y Cajal
Madrid, Spain, 28000
Hospital Clinico San Carlos
Madrid, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Spain
Sweden
Angelholms Sjukhus, Medicinkliniken
Angelhom, Sweden
Sahlgrenska University Hospital, Intermedicin
Gothenburg, Sweden
Hjartmottagningen
Helsingborg, Sweden
Lakarcentrum Nyponet
Karineholm, Sweden
Medicinkliniken
Ludvika, Sweden
Narsjukhuset Sandviken, Kardiologlab, Medicin
Sandviken, Sweden
Huslakaren i Sandviken
Sandviken, Sweden
Hjart & Karlcenter
Sodertalje, Sweden
Karolinska Universitetssjukhuset
Stockholm, Sweden
Hjarthuset AB
Varberg, Sweden
Sponsors and Collaborators
Kowa Research Europe
Investigators
Study Director: Dragos Budinski, MD Kowa Research Europe
  More Information

No publications provided by Kowa Research Europe

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dragos Budinski, Kowa Research Europe
ClinicalTrials.gov Identifier: NCT00344175     History of Changes
Other Study ID Numbers: NK-104-309
Study First Received: June 22, 2006
Results First Received: September 1, 2009
Last Updated: January 25, 2010
Health Authority: Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency

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

Additional relevant MeSH terms:
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Dyslipidemias
Hypercholesterolemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
Simvastatin
Pitavastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014