Clinical Trials Logo
  1. Home
  2. Primary Hypercholesterolemia
  3. NCT05206578
  4. Details
NCT05206578 Clinical Trial

Study 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 AGT and AGZ Versus Monotherapy of AGT in Patients With Primary Hypercholesterolemia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05206578
Other study ID # AG1901 P3
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 8, 2020
Est. completion date September 8, 2022

Study information
Verified date January 2022
Source Ahn-Gook Pharmaceuticals Co.,Ltd
Contact Yumi Hong
Phone 02-3289-4238
Email ymhelena@ahn-gook.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 264
Est. completion date September 8, 2022
Est. primary completion date July 7, 2022
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:
• AGT2, AGZ
Tablet, q.d.
• AGT2
Tablet, q.d.
• AGT4, AGZ
Tablet, q.d.
• AGT4
Tablet, q.d.

Locations
Country Name City State
Korea, Republic of Yonsei severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Ahn-Gook Pharmaceuticals Co.,Ltd

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 change in LDL-C level Week 4
See also
  Status Clinical Trial Phase
Recruiting NCT05559606 - An OS to Evaluate the Safety & Efficacy of Fixed Dose Combination Therapy With Atorvastatin and Ezetimibe
Completed NCT03571087 - Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia Phase 3
Completed NCT00776321 - Eprotirome for the Treatment of Dyslipidemia, Efficacy and Safety 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia Phase 2
Recruiting NCT05399992 - Study Evaluating Effectiveness and Adherence of Inclisiran Plus Standard of Care (SoC) Lipid-lowering Therapy Compared to SoC in ASCVD
Withdrawn NCT05798390 - Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia
Completed NCT06448962 - Phase 3 Study to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022 Phase 3
Completed NCT00724477 - Retrospective Evaluation of the Percentage of Subjects Who Have Reached Their LDL-C Objectives After Treatment With INEGY (Study P05103)(COMPLETED)
Completed NCT00249249 - Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels Phase 3
Recruiting NCT05657574 - A Clinical Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia Phase 3
Completed NCT02941848 - Evaluate the Pharmacokinetics and Safety of HCP1306 and Co-administration of HGP0816, HGP1404 in Healthy Male Volunteers Phase 1
Completed NCT03516955 - Efficacy and Safety of a Generic Rosuvastatin in a Real-world Setting
Completed NCT01012219 - A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination (MK-0524A-114)(COMPLETED) Phase 1
Completed NCT05131997 - A Study to Evaluate the Efficacy and Safety of AD-221 and AD-221A Phase 3
Terminated NCT03433755 - Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia Phase 3
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
Terminated NCT01335997 - Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143) Phase 3
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)