NCT00552097 (ENHANCE) is a Phase 3 clinical trial of ezetimibe (plus simvastatin) in Atherosclerosis, sponsored by Organon and Co.

Who is sponsoring NCT00552097?

NCT00552097 is sponsored by Organon and Co.

What drugs are being tested in NCT00552097?

Interventions in NCT00552097: ezetimibe (plus simvastatin), placebo (plus simvastatin).

What condition does NCT00552097 study?

NCT00552097 studies Atherosclerosis, Hypercholesterolemia, Hyperlipoproteinemia Type II.

Is NCT00552097 still recruiting?

NCT00552097 is currently completed. Last updated 15 August 2024.

Last reviewed 2024-08-15 · How we verify

NCT00552097: ENHANCE

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

Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE)(P02578)

Completed Phase 3 Last updated 15 August 2024

What this trial tests

Phase 3 trial testing ezetimibe (plus simvastatin) in Atherosclerosis in 720 participants. Completed in 25 April 2006.

Timeline

1 June 2002

Primary endpoint
25 April 2006

25 April 2006

Quick facts

Lead sponsor	Organon and Co
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	720
Start date	1 June 2002
Primary completion	25 April 2006
Estimated completion	25 April 2006

Drugs / interventions tested

ezetimibe (plus simvastatin)
placebo (plus simvastatin) — full drug profile →

Conditions studied

Atherosclerosis — all drugs for Atherosclerosis →
Hypercholesterolemia — all drugs for Hypercholesterolemia →
Hyperlipoproteinemia Type II — all drugs for Hyperlipoproteinemia Type II →

Sponsor

Organon and Co — full company profile →

Who can join

Adults 30 to 75, any sex, with Atherosclerosis or Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the study is to determine whether ezetimibe plus simvastatin will be more effective than simvastatin alone in preventing progression of atherosclerosis of the inner layer of the carotid artery.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Simvastatin with or without ezetimibe in familial hypercholesterolemia.
Kastelein JJ, Akdim F, Stroes ES, Zwinderman AH, et al · · 2008 · cited 806× · PMID 18376000 · DOI 10.1056/nejmoa0800742
Network Meta-Analysis of Randomized Trials Evaluating the Comparative Efficacy of Lipid-Lowering Therapies Added to Maximally Tolerated Statins for the Reduction of Low-Density Lipoprotein Cholesterol.
Toth PP, Bray S, Villa G, Palagashvili T, et al · · 2022 · cited 35× · PMID 36073669 · DOI 10.1161/jaha.122.025551

Verify or expand the search:

Other recruiting trials for Atherosclerosis

Currently open trials in the same condition.

NCT07448038 — A Study to Evaluate the Efficacy, Safety, Pharmacodynamics (PD), and Pharmacokinetics (PK) of Selnoflast in Reducing Vas · Phase 2 · recruiting
NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
NCT06788431 — A Clinical Study of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary · EARLY_PHASE1 · recruiting
NCT06676046 — Natural History of Uncommon Dyslipidemias, Rare Lipid Disorders and Unusual Atherosclerotic Conditions · recruiting
NCT06694012 — Osaka Cardiometabolic Epidemiological Study: Ohtori Study Part 2 · recruiting

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 NCT00552097 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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/NCT00552097.

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