TWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement)(0653-060)

Organon and Co1,496 enrolled

Overview

In patients with primary hypercholesterolemia treated with a statin and with ldl-c above the recommended target goal (esc 2003 recommendations ldl\>=1.15 g/l) to compare the efficacy and the safety of ezetrol added to ongoing statin and non drug therapeutic intervention (patient motivation on diet or physical activities or both).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,496

Conditions

Hypercholesterolaemia Hyperlipidaemia

Interventions

MK-0653, ezetimibeDRUG

Duration of Treatment: 3 monthsDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Primary hypercholesterolemia treated with any statin at any dose, for at least 3 months with a ldl cholesterol above 115 mg/dl (esc 2003 recommendations). Exclusion Criteria: * pregnant or breast feeding women * Lipid-lowering agents including hmg-coa reductase inhibitors other than the current statin, fish oils, cholestyramin, niacin (\>200 mg/day) and fibrates taken within the 3 months preceding visit 1.

Outcomes

Primary Outcomes

Percent of patients attaining the ldl cholesterol target goal based on the lipids result at the end of the study (3 months).

Secondary Outcomes

Treatment with ezetimibe 10 mg/day will be well tolerated and no difference in tolerance will be shown between the 3 treatment groups.

Data from ClinicalTrials.gov

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