NCT02460159

A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-384)

A Phase III, Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653C in Japanese Patients With Hypercholesterolemia Who Have Inadequate LDL-C Control on Ezetimibe or Atorvastatin Calcium Monotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and tolerability of Ezetimibe (EZ) 10 mg/Atorvastatin (Atora) 10 mg and EZ 10mg/Atora 20 mg fixed-dose combination (FDC) in Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Atorvastatin up to 20 mg. There is no formal hypothesis for the study.

Conditions

• Hypercholesterolemia
• Heterozygous Familial Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	EZ 10 mg/Atorva 20 mg FDC
DRUG	EZ 10 mg/Atorva 10 mg FDC

Timeline

• Start date: 2015-06-23
• Primary completion: 2016-12-22
• Completion: 2016-12-22
• First posted: 2015-06-02
• Last updated: 2024-05-16
• Results posted: 2018-01-11