TWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement) - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00328523

Purpose

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).

Condition	Intervention	Phase
Hypercholesterolaemia Hyperlipidaemia	Drug: MK-0653, ezetimibe Drug: Duration of Treatment: 3 months	Phase III

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Ezetimibe Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Ezetimibe Together With Any Statin Cholesterol Enhancement

Further study details as provided by Merck:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	1500
Study Start Date:	June 2004

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328523

Locations

France
Laboratoires Merck Sharp & Dohme - Chibret
Paris, France, 75114

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Study ID Numbers:	2006_024
Study First Received:	May 19, 2006
Last Updated:	May 19, 2006
ClinicalTrials.gov Identifier:	NCT00328523
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Ezetimibe
Metabolic disorder

Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Antilipemic Agents
Anticholesteremic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009