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NCT03867318
Efficacy and Safety Study of Ezetimibe (SCH 58235, MK-0653) in Addition to Atorvastatin in Participants With Coronary Heart Disease or Multiple Cardiovascular Risk Factors (P00693/MK-0653-030)
Phase 3 trial testing Atorvastatin in Hypercholesterolemia in 621 participants. Completed in 16 November 2001.
16 November 2001
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 | 621 |
| Start date | 24 April 2000 |
| Primary completion | 16 November 2001 |
| Estimated completion | 16 November 2001 |
Drugs / interventions tested
- Atorvastatin (atorvastatin) — full drug profile →
- Ezetimibe (EZETIMIBE) — full drug profile →
- Placebo for Ezetimibe
- Placebo for Atorvastatin
Conditions studied
- Hypercholesterolemia — all drugs for Hypercholesterolemia →
Sponsor
Organon and Co — full company profile →
Who can join
18 and older, any sex, with Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The overall objective is to evaluate the efficacy and safety of ezetimibe (SCH 058235/MK-0653) 10 mg administered daily in conjunction with atorvastatin in participants with Heterozygous Familial Hypercholesterolemia (HeFH) or in participants with coronary heart disease (CHD) or multiple cardiovascular risk factors (≥2 risk factors) and primary hypercholesterolemia not controlled by a starting dose (10 mg/day) of atorvastatin. The primary hypothesis is that the coadministration of ezetimibe 10 mg/day with atorvastatin therapy will result in a significantly greater proportion of participants achieving target low-density lipoprotein cholesterol (LDL-C) (≤100 mg/dL) when compared to the atorvastatin administered alone.
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:
- PubMed search for NCT03867318
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Atorvastatin
Trials testing the same drug.
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- NCT07530289 — A Clinical Study of Ulonivirine (MK-8507) With Atorvastatin and Metformin in Healthy Adults (MK-8507-018) · Phase 1 · not yet recruiting
- NCT07534592 — A Study to Investigate the Effect of Elecoglipron on Rosuvastatin and Atorvastatin in Healthy Participants · Phase 1 · not yet recruiting
- NCT07502001 — Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin · Phase 1 · not yet recruiting
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)
- Trial protocol + status: ClinicalTrials.gov NCT03867318 (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: 10 May 2024
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing