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NCT04584736 Clinical Trial

To Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia

Primary Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04584736
Other study ID # JWP-PTZ-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 11, 2019
Est. completion date October 12, 2020

Study information
Verified date August 2020
Source JW Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 283
Est. completion date October 12, 2020
Est. primary completion date July 16, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years to 79 Years
Eligibility Inclusion Criteria: - Patients with primary hypercholesterolemia Exclusion Criteria: - The subject not meet the specified LDL-C level

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Livalo, Ezetrol
Pitavastatin+Ezetimibe Pitavastatin

Locations
Country Name City State
Korea, Republic of Gangdong Sacred Heart Hospital Seoul Korea

Sponsors (1)
Lead Sponsor Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary % change in LDL-C level from baseline at Week 8 change in LDL-C level Week 8
Secondary Change in LDL-C level from baseline at Week 4 and Week 8 change in LDL-C level Week 4 and Week 8
See also
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Completed NCT00867165 - Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522) Phase 3
Not yet recruiting NCT06386419 - A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia Phase 4
Active, not recruiting NCT03952169 - Effect of Probiotics on Lipid Management N/A
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Completed NCT02087917 - A 4-week, Randomized, Placebo-Controlled, Double-Blind, Efficacy and Safety Study of HS-25 in Adults With Primary Hypercholesterolemia Phase 2
Completed NCT00704535 - Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)