To Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients With Essential Hypertension and Primary Hypercholesterolemia (HODO-2224)

May 19, 2025 updated by: Hyundai Pharm

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients With Essential Hypertension and Primary Hypercholesterolemia

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Phase 3 trial to Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients with Essential Hypertension and Primary Hypercholesterolemia

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This trial is a phase 3 study to evaluate the efficacy and safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients with Essential Hypertension and Primary Hypercholesterolemia.

This is multi-center, double-blind, Active-controlled, parallel-group, phase 3 study.

Study Type

Interventional

Enrollment (Estimated)

125

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 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 19
  • Patients with Essential Hypertension and Primary Hypercholesterolemia

Exclusion Criteria:

  • Patients with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
  • Patients with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HODO-2224-1+HODO-2224-2+HODO-2224-4
Oral tablet, QD
Drug: Ezetimibe/Rosuvastatin/Candesartan/Amlodipine
PO, QD, 8 weeks
Active Comparator: HODO-2224-1+HODO-2224-4+HODO-2224-5
Oral tablet, QD
Drug: Candesartan/Amlodipine
PO, QD, 8 weeks
Active Comparator: HODO-2224-2+HODO-2224-3+HODO-2224-6
Oral tablet, QD
Drug: Candesartan/Rosuvastatin/Ezetimibe
PO, QD, 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Low density lipoprotein cholesterol (LDL-C)
Time Frame: baseline and week 8
LDL-C change at Week 8 compared HODO-2224-1 + HODO-2224-4 + HODO-2224-5 with HODO-2224
baseline and week 8
Mean sitting systolic blood pressure (MSSBP)
Time Frame: baseline and week 8
MSSBP change at week 8 compared HODO-2224-2 + HODO-2224-3 + HODO-2224-6 with HODO-2224
baseline and week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of other Lipid profile
Time Frame: 0, 4, 8 weeks
change of other Lipid profile
0, 4, 8 weeks

Collaborators and Investigators

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

Sponsor

Hyundai Pharm

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)

April 22, 2025

Primary Completion (Actual)

May 19, 2025

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

October 15, 2024

First Submitted That Met QC Criteria

October 15, 2024

First Posted (Actual)

October 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD_CARE_002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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