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Completed

NCT Number: NCT00344175

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

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

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Key information

Conditions

Hypercholesterolemia Cardiovascular Diseases Coronary Disease Coronary Heart Disease Dyslipidemia Dyslipidemias Heart Diseases Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Y Forskning, Bispebjerg Hospital, Copenhagen Nv, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Withdrawn or terminated from NK-104-304 (00309738)

Treatment and study plan

Pitavastatin

Drug

simvastatin

Drug

Primary outcomes

  1. Number of Patients Attaining NCEP LDL-C Target at Week 16

    Time frame: 16 weeks

    Number of patients attaining the National Cholesterol Education Program (NCEP) LDL-C target at Week 16. According to NCEP criteria the target LDL-C is 100 mg/dL.

  2. Number of Patients Attaining NCEP LDL-C Target at Week 44

    Time frame: 44 Weeks

    Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at Week 44. According to NCEP criteria the target LDL-C is 100 mg/dL.

Secondary outcomes

  1. Percent Change From Baseline in LDL-C

    Time frame: Baseline to 44 weeks

Sponsors and collaborators

Lead sponsor

Kowa Research Europe

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 26, 2006
Registry last updated
Feb 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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