NCT03884452

Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018)

A Phase III Efficacy And Safety Study of Ezetimibe (SCH58235) 10 mg in Addition to Atorvastatin or Simvastatin in the Therapy of Homozygous Familial Hypercholesterolemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy and the safety of ezetimibe (SCH 58235) co-administered with either atorvastatin or simvastatin in participants with homozygous familial hypercholesterolemia (FH).

Conditions

• Familial Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Atorvastatin	Tablets taken orally once daily in the morning
DRUG	Simvastatin	Tablets taken orally once daily in the morning or evening
DRUG	Ezetimibe	Tablet taken orally once daily in the morning or evening
DRUG	Placebo for Ezetimibe	Tablets taken orally once daily in the morning or evening

Timeline

• Start date: 2000-05-03
• Primary completion: 2001-05-24
• Completion: 2001-05-24
• First posted: 2019-03-21
• Last updated: 2024-05-10