Back to resultsTWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement)(0653-060)
Primary Purpose
Hypercholesterolaemia, Hyperlipidaemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK-0653, ezetimibe
Duration of Treatment: 3 months
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolaemia
Eligibility 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.
Sites / Locations
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00328523
Brief Title
TWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement)(0653-060)
Official Title
Ezetimibe Together With Any Statin Cholesterol Enhancement
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolaemia, Hyperlipidaemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1496 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK-0653, ezetimibe
Intervention Type
Drug
Intervention Name(s)
Duration of Treatment: 3 months
Primary Outcome Measure Information:
Title
Percent of patients attaining the ldl cholesterol target goal based on the lipids result at the end of the study (3 months).
Secondary Outcome Measure Information:
Title
Treatment with ezetimibe 10 mg/day will be well tolerated and no difference in tolerance will be shown between the 3 treatment groups.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19059567
Citation
Steg PG, Verdier JC, Carre F, Darne B, Ducardonnet A, Jullien G, Farnier M, Giral P, Haiat R; TWICE Investigators, France. A randomised trial of three counselling strategies for lifestyle changes in patients with hypercholesterolemia treated with ezetimibe on top of statin therapy (TWICE). Arch Cardiovasc Dis. 2008 Nov-Dec;101(11-12):723-35. doi: 10.1016/j.acvd.2008.10.008. Epub 2008 Nov 20.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
CSRSynopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
TWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement)(0653-060)
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