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Enrolling by Invitation

NCT Number: NCT06646354

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Primary Hypercholesterolaemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hanyang University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ezetimibe/Rosuvastatin/Candesartan/Amlodipine

Drug

PO, QD, 8 weeks

Candesartan/Amlodipine

Drug

PO, QD, 8 weeks

Candesartan/Rosuvastatin/Ezetimibe

Drug

PO, QD, 8 weeks

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. change of other Lipid profile

    Time frame: 0, 4, 8 weeks

    change of other Lipid profile

Sponsors and collaborators

Lead sponsor

Hyundai Pharm

Industry

Registry information

Official study title

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

Acronym: HODO-2224

Important dates

Study start
2025
Primary completion
2025
Study completion
2028
First posted
Oct 17, 2024
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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