NCT00092820 is a Phase 3 clinical trial of MK0653, ezetimibe in Lipid Metabolism, Inborn Errors, sponsored by Organon and Co.

Who is sponsoring NCT00092820?

NCT00092820 is sponsored by Organon and Co.

What drugs are being tested in NCT00092820?

Interventions in NCT00092820: MK0653, ezetimibe, Comparator: placebo.

What condition does NCT00092820 study?

NCT00092820 studies Lipid Metabolism, Inborn Errors, Heart Disease.

Is NCT00092820 still recruiting?

NCT00092820 is currently completed. Last updated 15 August 2024.

Last reviewed 2024-08-15 · How we verify

NCT00092820

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Sitosterolemia Extension Study (0653-004)(COMPLETED)

Completed Phase 3 Last updated 15 August 2024

What this trial tests

Phase 3 trial testing MK0653, ezetimibe in Lipid Metabolism, Inborn Errors in 58 participants. Completed in 30 November 2004.

Timeline

12 February 2001

Primary endpoint
18 September 2001

30 November 2004

Quick facts

Lead sponsor	Organon and Co
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	58
Start date	12 February 2001
Primary completion	18 September 2001
Estimated completion	30 November 2004

Drugs / interventions tested

MK0653, ezetimibe — full drug profile →
Comparator: placebo — full drug profile →

Conditions studied

Lipid Metabolism, Inborn Errors — all drugs for Lipid Metabolism, Inborn Errors →
Heart Disease — all drugs for Heart Disease →

Sponsor

Organon and Co — full company profile →

Who can join

10 and older, any sex, with Lipid Metabolism, Inborn Errors or Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of MK0653, ezetimibe

Trials testing the same drug.

NCT00092807 — Sitosterolemia Extension Study (0653-003)(COMPLETED) · Phase 3 · completed

Other Organon and Co trials

Trials by the same sponsor.

NCT05761444 — Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients · Phase 4 · completed
NCT05789576 — A Study to Investigate Efficacy and Safety of VTAMA® (Tapinarof) Cream, 1% in Plaque Psoriasis in the Head and Neck Regi · Phase 4 · completed
NCT05680740 — A Study to Investigate Efficacy and Safety of VTAMA (Tapinarof) Cream, 1% in Intertriginous Plaque Psoriasis · Phase 4 · completed
NCT05560646 — A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo in Participants Aged 18 · Phase 2 · completed
NCT05264506 — Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive · Phase 3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00092820 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Organon and Co
Last refreshed: 15 August 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00092820.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing