NCT04584736

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
283

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2019

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2020

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
Last Updated

December 1, 2021

Status Verified

August 1, 2020

Enrollment Period

1.1 years

First QC Date

October 6, 2020

Last Update Submit

November 29, 2021

Conditions

Primary Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • % change in LDL-C level from baseline at Week 8

    change in LDL-C level

    Week 8

Secondary Outcomes (1)

  • Change in LDL-C level from baseline at Week 4 and Week 8

    Week 4 and Week 8

Study Arms (4)

Livalo 2mg, Ezetrol 10mg

EXPERIMENTAL

Pitavastatin 2mg, Ezetimibe 10mg

Drug: Livalo, Ezetrol

Livalo 2mg

ACTIVE COMPARATOR

Pitavastatin 2mg

Drug: Livalo, Ezetrol

Livalo 4mg, Ezetrol 10mg

EXPERIMENTAL

Pitavastatin 4mg, Ezetimibe 10mg

Drug: Livalo, Ezetrol

Livalo 4mg

ACTIVE COMPARATOR

Pitavastatin 4mg

Drug: Livalo, Ezetrol

Interventions

Livalo, EzetrolDRUG

Pitavastatin+Ezetimibe Pitavastatin

Also known as: Pitavastatin, Ezetimibe
Livalo 2mgLivalo 2mg, Ezetrol 10mgLivalo 4mgLivalo 4mg, Ezetrol 10mg

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with primary hypercholesterolemia

You may not qualify if:

  • The subject not meet the specified LDL-C level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangdong Sacred Heart Hospital

Seoul, Korea, 134-701, South Korea

Location

Related Publications (1)

  • Jeong HS, Hong SJ, Cho JM, Han KH, Cha DH, Jo SH, Kang HJ, Choi SY, Choi CU, Cho EJ, Jeong YH, Gwon HC, Kim BK, Lee SY, Kim SH, Ahn JC, Hong YJ, Kim WS, Woo SI, Park TH, Han KR. A Multicenter, Randomized, Double-blind, Active-controlled, Factorial Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia. Clin Ther. 2022 Oct;44(10):1310-1325. doi: 10.1016/j.clinthera.2022.09.001. Epub 2022 Oct 12.

    PMID: 36241463DERIVED

MeSH Terms

Interventions

pitavastatinEzetimibe

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • dongryeong lee, Manager

    +82-2-840-6982

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 14, 2020

Study Start

June 11, 2019

Primary Completion

July 16, 2020

Study Completion

October 12, 2020

Last Updated

December 1, 2021

Record last verified: 2020-08

Locations

KR(1)