ClinicalTrials.gg
TerminatedNCT00092833Updated Aug 15, 2024

Investigational Drug in Patients With Hypercholesterolemia or in Patients With Sitosterolemia (0653-026)(COMPLETED)

A Phase 3 interventional study of Comparator: ezetimibe in Hypercholesterolemia, Familial and Lipid Metabolism, Inborn Errors, sponsored by Organon and Co. Terminated. Open to participants aged 8 Years and older. 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
49
Allocation
Non-randomized
Ages
8 Years and older
Sex
All
01

Study summary

The purpose of this study is to provide an investigational drug to patients with a specific type of hypercholesterolemia (high cholesterol) or sitosterolemia (unusually high absorption of non-cholesterol sterols) in a treatment use setting.

02

Conditions studied

  • Hypercholesterolemia, Familial
  • Lipid Metabolism, Inborn Errors
03

In context

Hyperlipoproteinemia Type II

249 studies on the registry are indexed under Hyperlipoproteinemia Type II; 56 are open to participants now.

This study's enrollment of 49 is below the median of 134 across 178 interventional studies indexed under Hyperlipoproteinemia Type II.

Browse Hyperlipoproteinemia Type II 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.

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

04

Who can participate

Ages eligible
8 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

  • Homozygous familial hypercholesterolemia or sitosterolemia

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
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    1

    Ezetimibe

    Drug: Comparator: ezetimibe

Interventions

06

What researchers measure

Primary outcomes

  1. Incidence of clinical and laboratory adverse experiences in in patients with homozygous FH or homozygous sitosterolemia taking ezetimibe 10 mg/day

    Time frame: 3 years

07

Study locations

No study locations are listed for this record.

08

Timeline

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

The record gives a start of Jul 2002, a primary completion of May 2005 and a completion of May 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
Jul 2002
Primary completionActual
May 2005
CompletionActual
May 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 ↗
09

Registry details

Key details

Study ID
NCT00092833
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Sep 28, 2004
Start date
Jul 2002
Primary completion
May 2005
Completion
May 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 terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Ezetimibe

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