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

Kowa Research Europe178 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

178

Conditions

Hypercholesterolemia Dyslipidemia Coronary Heart Disease

Interventions

pitavastatinDRUG

simvastatinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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or combined dyslipidemia * 2 or more risk factors for coronary heart disease (CHD) Exclusion Criteria: * Withdrawn or terminated from NK-104-304 (00309738)

Locations (28)

Y Forskning, Bispebjerg Hospital

Copenhagen Nv, Denmark

Outcomes

Primary Outcomes

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

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.

Time frame: 16 weeks

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

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.

Time frame: 44 Weeks

Secondary Outcomes

Percent Change From Baseline in LDL-C

Time frame: Baseline to 44 weeks

Data from ClinicalTrials.gov

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