ClinicalTrials.gg
Sign In
CompletedNCT00092898Updated Aug 15, 2024

An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(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 18 Years to 85 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
30
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

This is a 6-month study with patients who have the rare disease, sitosterolemia which may result in heart-related diseases. These patients have unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study investigates whether absorption of these non-cholesterols can be reduced in these patients.

Read the detailed description

The duration of treatment is 26 weeks.

02

Conditions studied

  • Lipid Metabolism, Inborn Errors
  • Heart Disease

Keywords

  • 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 30 is below 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
18 Years to 85 Years
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

  • 18 years or older, with a history of elevated sitosterol levels and have received treatment for at least 6 months prior to study entry.

Exclusion criteria

Exclusion Criteria:

  • Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study.
05

Study design

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

Interventions

06

What researchers measure

Primary outcomes

  1. Sitosterol concentrations after 26 weeks.

    Time frame: After 26 weeks

Secondary outcomes

  1. Campesterol concentrations; Achilles tendon thickness; safety and tolerability.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Musliner T, Cselovszky D, Sirah W, McCrary Sisk C, Sapre A, Salen G, Lutjohann D, von Bergmann K. Efficacy and safety of ezetimibe 40 mg vs. ezetimibe 10 mg in the treatment of patients with homozygous sitosterolaemia. Int J Clin Pract. 2008 Jul;62(7):995-1000. doi: 10.1111/j.1742-1241.2008.01786.x. Epub 2008 May 14. PubMed 18484971 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2004, a primary completion of Sep 2005 and a completion of Oct 2005. It does not say whether these dates are actual or estimated.

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

Registered
Sep 23, 2004
First posted
Sep 28, 2004
Start
Oct 2004
Primary completionActual
Sep 2005
CompletionActual
Oct 2005
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
NCT00092898
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Sep 28, 2004
Start date
Oct 2004
Primary completion
Sep 2005
Completion
Oct 2005
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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Ezetimibe

Other studies in this condition

Lipid Metabolism, Inborn Errors →

Other studies from this sponsor

Organon and Co →

Start the discussion