To Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia

JW Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Primary Hypercholesterolemia

Treatments: Drug: Livalo, Ezetrol

Study type: Interventional

Funder types: Industry

Identifiers

NCT04584736

JWP-PTZ-301

Details and patient eligibility

About

To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia.

Full description

A Multi-center, Randomized, Double-blinded, Active-controlled, Factorial Design Phase 3 Clinical Trial

Enrollment: 283 patients

Sex: All

Ages: 19 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with primary hypercholesterolemia

Exclusion criteria

• The subject not meet the specified LDL-C level

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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283 participants in 4 patient groups

Livalo 2mg, Ezetrol 10mg

Experimental group

Description:

Pitavastatin 2mg, Ezetimibe 10mg

Treatment:

Drug: Livalo, Ezetrol

Livalo 2mg

Active Comparator group

Description:

Pitavastatin 2mg

Treatment:

Drug: Livalo, Ezetrol

Livalo 4mg, Ezetrol 10mg

Experimental group

Description:

Pitavastatin 4mg, Ezetimibe 10mg

Treatment:

Drug: Livalo, Ezetrol

Livalo 4mg

Active Comparator group

Description:

Pitavastatin 4mg

Treatment:

Drug: Livalo, Ezetrol