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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00328523
Recruitment Status : Completed
First Posted : May 22, 2006
Last Update Posted : March 10, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Hypercholesterolaemia Hyperlipidaemia Drug: MK-0653, ezetimibe Drug: Duration of Treatment: 3 months Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1496 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ezetimibe Together With Any Statin Cholesterol Enhancement
Study Start Date : June 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Ezetimibe

Primary Outcome Measures :
  1. 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 :
  1. Treatment with ezetimibe 10 mg/day will be well tolerated and no difference in tolerance will be shown between the 3 treatment groups.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00328523

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Study Data/Documents: CSRSynopsis  This link exits the site

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00328523     History of Changes
Other Study ID Numbers: 0653-060
First Posted: May 22, 2006    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents