NCT00442897 is a Phase 4 clinical trial of simvastatin (+) ezetimibe in Hypercholesterolemia, sponsored by Organon and Co.

Who is sponsoring NCT00442897?

NCT00442897 is sponsored by Organon and Co.

What drugs are being tested in NCT00442897?

Interventions in NCT00442897: simvastatin (+) ezetimibe, Comparator: atorvastatin.

What condition does NCT00442897 study?

NCT00442897 studies Hypercholesterolemia.

Is NCT00442897 still recruiting?

NCT00442897 is currently completed. Last updated 8 May 2024.

Are results published for NCT00442897?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-05-08 · How we verify

NCT00442897

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

Evaluate The Lipid-Lowering Efficacy and Safety of Vytorin in Comparison With Atorvastatin in Hypercholesterolaemic Patients With Coronary Artery Disease

Completed Phase 4 Results posted Last updated 8 May 2024

What this trial tests

Phase 4 trial testing simvastatin (+) ezetimibe in Hypercholesterolemia in 229 participants. Completed in 1 October 2008.

Timeline

1 September 2006

Primary endpoint
1 October 2008

1 October 2008

Quick facts

Lead sponsor	Organon and Co
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	229
Start date	1 September 2006
Primary completion	1 October 2008
Estimated completion	1 October 2008

Drugs / interventions tested

simvastatin (+) ezetimibe
Comparator: atorvastatin — full drug profile →

Conditions studied

Hypercholesterolemia — all drugs for Hypercholesterolemia →

Sponsor

Organon and Co — full company profile →

Who can join

Adults 18 to 80, any sex, with Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment
Time frame: After 6 weeks of treatment
Primary objective is to evaluate the proportion of patients achieving LDL-C target \<100 mg/dl recommend in National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) after 6 weeks of treatment(vytorin 10/20 vs. atorvastatin 10 mg)

Sponsor's own description

Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines

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 recruiting trials for Hypercholesterolemia

Currently open trials in the same condition.

NCT07406191 — WB-EMS Effects on Cardiometabolic Risk Factors · NA · recruiting
NCT07374861 — Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy · recruiting
NCT07295327 — Effect of Two Food Supplements on Lipid Profile in Patients With Mild Hypercholesterolemia · NA · recruiting
NCT06568601 — Pharmacogenomic Informed Statin Prescribing · NA · recruiting
NCT06423365 — A Tool to Help Patients With Muscle Symptoms After Taking a Statin Medication. · NA · active not 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 NCT00442897 (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: 8 May 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/NCT00442897.

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