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CompletedNCT00092820Updated Aug 15, 2024

Sitosterolemia Extension Study (0653-004)(COMPLETED)

A Phase 3 interventional study of MK0653, ezetimibe and Comparator: placebo in Lipid Metabolism, Inborn Errors and Heart Disease, sponsored by Organon and Co. Completed. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.

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

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled Feb 2001, registered Sep 2004).
Phase
Phase 3
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
10 Years and older
Sex
All
01

Study summary

This is an extension study for patients having unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study will evaluate the long term safety and the ability to lower cholesterol levels with an investigational drug.

Read the detailed description

The duration of treatment is 52 weeks.

02

Conditions studied

  • Lipid Metabolism, Inborn Errors
  • Heart Disease

Keywords

  • Homozygous Sitosterolemia
03

In context

Lipid Metabolism, Inborn Errors

24 studies on the registry are indexed under Lipid Metabolism, Inborn Errors; 3 are open to participants now.

This study's enrollment of 58 is above the median of 38 across 18 interventional studies indexed under Lipid Metabolism, Inborn Errors.

Browse Lipid Metabolism, Inborn Errors studies →

Lead sponsor

Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.

Browse Organon & Co. studies →

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

04

Who can participate

Ages eligible
10 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with elevated sitosterol levels while taking current medication

Exclusion criteria

Exclusion Criteria:

  • Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
58 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. Plasma sitosterol levels after 52 weeks.

Secondary outcomes

  1. Plasma LDL-C and plasma campesterol. Safety and tolerability.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Salen G, von Bergmann K, Lutjohann D, Kwiterovich P, Kane J, Patel SB, Musliner T, Stein P, Musser B; Multicenter Sitosterolemia Study Group. Ezetimibe effectively reduces plasma plant sterols in patients with sitosterolemia. Circulation. 2004 Mar 2;109(8):966-71. doi: 10.1161/01.CIR.0000116766.31036.03. Epub 2004 Feb 9. PubMed 14769702 ↗
  • Lutjohann D, von Bergmann K, Sirah W, Macdonell G, Johnson-Levonas AO, Shah A, Lin J, Sapre A, Musliner T. Long-term efficacy and safety of ezetimibe 10 mg in patients with homozygous sitosterolemia: a 2-year, open-label extension study. Int J Clin Pract. 2008 Oct;62(10):1499-510. doi: 10.1111/j.1742-1241.2008.01841.x. PubMed 18822021 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2001 to primary completion in Sep 2001, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 23, 2004
First posted
Sep 28, 2004
StartActual
Feb 12, 2001
Primary completionActual
Sep 18, 2001
CompletionActual
Nov 30, 2004
Last update
Aug 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
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
NCT00092820
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Sep 28, 2004
Start date
Feb 12, 2001
Primary completion
Sep 18, 2001
Completion
Nov 30, 2004
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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