NCT03867110

An Efficacy and Safety Study of Ezetimibe (MK-0653, SCH 58235) in Addition to Atorvastatin Compared to Placebo in Participants With Primary Hypercholesterolemia (MK-0653-013)

Completed Phase 3 Last updated 10 May 2024

What this trial tests

Phase 3 trial testing Placebo in Hypercholesterolemia in 628 participants. Completed in 27 July 2001.

Timeline

6 March 2000

Primary endpoint
27 July 2001

27 July 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	628
Start date	6 March 2000
Primary completion	27 July 2001
Estimated completion	27 July 2001

Drugs / interventions tested

• Placebo
• Ezetimibe 10 mg — full drug profile →
• Atorvastatin 10 mg — full drug profile →
• Atorvastatin 20 mg
• Atorvastatin 40 mg — full drug profile →
• Atorvastatin 80 mg — full drug profile →

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

This is a multicenter, randomized, double-blind, placebo-controlled, balanced-parallel-group, efficacy and safety trial of ezetimibe coadministered with atorvastatin in adult participants with primary hypercholesterolemia. The primary hypothesis is that the coadministration of ezetimibe 10 mg/day with atorvastatin (pooled across all doses: 10 mg, 20 mg, 40 mg, 80 mg) will result in a significantly greater reduction in direct low density lipoprotein-cholesterol (LDL-C) when compared with atorvastatin (pooled across all doses: 10 mg, 20 mg, 40 mg, 80 mg) alone and ezetimibe 10 mg alone.

Publications & conference data

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