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Completed

NCT Number: NCT04584736

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.

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Key information

Conditions

Primary Hypercholesterolemia

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gangdong Sacred Heart Hospital

Seoul, Korea, 134-701, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with primary hypercholesterolemia

Exclusion criteria

  • The subject not meet the specified LDL-C level

Treatment and study plan

Livalo, Ezetrol

Drug

Pitavastatin+Ezetimibe Pitavastatin

Other names: Pitavastatin, Ezetimibe

Primary outcomes

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

    Time frame: Week 8

    change in LDL-C level

Secondary outcomes

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

    Time frame: Week 4 and Week 8

    change in LDL-C level

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 14, 2020
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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