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Enrolling by invitation 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

Phase III Interventional Hypertension Primary Hypercholesterolaemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ezetimibe/Rosuvastatin/Candesartan/Amlodipine, Candesartan/Amlodipine, Candesartan/Rosuvastatin/Ezetimibe.
Who it may be relevant to
Registry conditions: Hypertension, Primary Hypercholesterolaemia. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

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.

Interventions

  • Drug Ezetimibe/Rosuvastatin/Candesartan/Amlodipine
    PO, QD, 8 weeks
  • Drug Candesartan/Amlodipine
    PO, QD, 8 weeks
  • Drug Candesartan/Rosuvastatin/Ezetimibe
    PO, QD, 8 weeks

Primary outcome measures

  • Low density lipoprotein cholesterol (LDL-C) [Time frame: baseline and week 8]
  • Mean sitting systolic blood pressure (MSSBP) [Time frame: baseline and week 8]
Secondary outcome measures (1)
  • change of other Lipid profile [Time frame: 0, 4, 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Hanyang University Hospital — Seoul

Identifiers

NCT: NCT06646354 · HD_CARE_002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗