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

NCT ID: NCT06646354

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-22

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Primary Hypercholesterolaemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HODO-2224-1+HODO-2224-2+HODO-2224-4

Oral tablet, QD

Group Type EXPERIMENTAL

Ezetimibe/Rosuvastatin/Candesartan/Amlodipine

Intervention Type DRUG

PO, QD, 8 weeks

HODO-2224-1+HODO-2224-4+HODO-2224-5

Oral tablet, QD

Group Type ACTIVE_COMPARATOR

Candesartan/Amlodipine

Intervention Type DRUG

PO, QD, 8 weeks

HODO-2224-2+HODO-2224-3+HODO-2224-6

Oral tablet, QD

Group Type ACTIVE_COMPARATOR

Candesartan/Rosuvastatin/Ezetimibe

Intervention Type DRUG

PO, QD, 8 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ezetimibe/Rosuvastatin/Candesartan/Amlodipine

PO, QD, 8 weeks

Intervention Type DRUG

Candesartan/Amlodipine

PO, QD, 8 weeks

Intervention Type DRUG

Candesartan/Rosuvastatin/Ezetimibe

PO, QD, 8 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hyundai Pharm

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hanyang University Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HD_CARE_002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.