NCT00328523

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,496

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2006

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

1.6 years

First QC Date

May 19, 2006

Last Update Submit

August 12, 2024

Conditions

HypercholesterolaemiaHyperlipidaemia

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

MK-0653, ezetimibeDRUG
Duration of Treatment: 3 monthsDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 19059567RESULT

MeSH Terms

Conditions

HypercholesterolemiaHyperlipidemias

Interventions

EzetimibeDuration of Therapy

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2006

First Posted

May 22, 2006

Study Start

June 1, 2004

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

August 15, 2024

Record last verified: 2022-02