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

Organon

Status and phase

Completed

Phase 3

Conditions

Hyperlipidaemia

Hypercholesterolaemia

Treatments

Drug: MK-0653, ezetimibe

Drug: Duration of Treatment: 3 months

Study type

Interventional

Funder types

Industry

Identifiers

NCT00328523

2006_024

0653-060

Details and patient eligibility

About

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).

Enrollment

1,496 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.