The Efficacy and Safety of a Combination Therapy of Rosuvastatin and Ezetimibe Versus Monotherapy of Rosuvastatin in Hypercholesterolemia Patients

IlDong Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Rosuvastatin/Ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT02251847

ID-ROEZ-301

Details and patient eligibility

About

To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients

Full description

To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients

Enrollment: 400 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hypercholesterolemic patient

Exclusion criteria

• Has history of hypersensitivity to HMG-CoA reductase inhibitor and Ezetimibe

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 6 patient groups

R5

Active Comparator group

Description:

Rosuvastatin 5mg

Treatment:

Drug: Rosuvastatin/Ezetimibe

R10

Active Comparator group

Description:

Rosuvastatin 10mg

Treatment:

Drug: Rosuvastatin/Ezetimibe

R20

Active Comparator group

Description:

Rosuvastatin 20mg

Treatment:

Drug: Rosuvastatin/Ezetimibe

R5/E10

Experimental group

Description:

Rosuvastatin 5mg/ezetimibe 10mg

Treatment:

Drug: Rosuvastatin/Ezetimibe

R10/E10

Experimental group

Description:

Rosuvastatin 10mg/ezetimibe 10mg

Treatment:

Drug: Rosuvastatin/Ezetimibe

R20/E10

Experimental group

Description:

Rosuvastatin 20mg/ezetimibe 10mg

Treatment:

Drug: Rosuvastatin/Ezetimibe