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CompletedNCT00328523Updated Aug 15, 2024

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

A Phase 3 interventional study of MK-0653, ezetimibe and Duration of Treatment: 3 months in Hypercholesterolaemia and Hyperlipidaemia, sponsored by Organon and Co. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-15.

Sponsored by Organon and Co · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,496
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Hypercholesterolaemia
  • Hyperlipidaemia
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 110 are open to participants now.

This study's enrollment of 1,496 is above the median of 100 across 992 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,496 participants (actual)

Interventions

  • DrugMK-0653, ezetimibe
  • DrugDuration of Treatment: 3 months
06

What researchers measure

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.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 19059567 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00328523
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
May 22, 2006
Start date
Jun 2004
Primary completion
Jan 2006
Completion
Jan 2006
Last update
Aug 15, 2024

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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