Study to Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia

January 12, 2022 updated by: Ahn-Gook Pharmaceuticals Co.,Ltd

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

264

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with primary hypercholesterolemia

Exclusion Criteria:

  • The subject not meet the specified LDL-C level

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AGT2, AGZ
Drug: AGT2, AGZ
Tablet, q.d.
Active Comparator: AGT2
Drug: AGT2
Tablet, q.d.
Experimental: AGT4, AGZ
Drug: AGT4, AGZ
Tablet, q.d.
Active Comparator: AGT4
Drug: AGT4
Tablet, q.d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% change in LDL-C level from baseline at Week 8
Time Frame: Week 8
change in LDL-C level
Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in LDL-C level from baseline at Week 4
Time Frame: Week 4
change in LDL-C level
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2020

Primary Completion (Anticipated)

July 7, 2022

Study Completion (Anticipated)

September 8, 2022

Study Registration Dates

First Submitted

January 12, 2022

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 25, 2022

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 12, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG1901 P3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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