To Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04584736

Enrollment

283

Registered

2020-10-14

Start date

2019-06-11

Completion date

2020-10-12

Last updated

2021-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hypercholesterolemia

Brief summary

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

Detailed description

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

Interventions

DRUGLivalo, Ezetrol

Pitavastatin+Ezetimibe Pitavastatin

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 79 Years

Healthy volunteers

Inclusion criteria

* Patients with primary hypercholesterolemia

Exclusion criteria

* The subject not meet the specified LDL-C level

Design outcomes

Primary

Measure	Time frame	Description
% change in LDL-C level from baseline at Week 8	Week 8	change in LDL-C level

Secondary

Measure	Time frame	Description
Change in LDL-C level from baseline at Week 4 and Week 8	Week 4 and Week 8	change in LDL-C level

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026