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 3

Not yet recruiting

• Conditions: Hypertension; Primary Hypercholesterolaemia
• Interventions: Drug: Ezetimibe/Rosuvastatin/Candesartan/Amlodipine; Drug: Candesartan/Amlodipine; Drug: Candesartan/Rosuvastatin/Ezetimibe

• Registration Number: NCT06646354
• Lead Sponsor: Hyundai Pharm

Brief Summary

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-15
• Last Update Submitted: 2024-10-15
• Study First Posted: 2024-10-17
• Last Update Posted: 2024-10-17
• Study Start: 2025-01-31
• Primary Completion: 2025-04-15
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HODO-2224-1+HODO-2224-2+HODO-2224-4	Ezetimibe/Rosuvastatin/Candesartan/Amlodipine	Oral tablet, QD
HODO-2224-1+HODO-2224-4+HODO-2224-5	Candesartan/Amlodipine	Oral tablet, QD
HODO-2224-2+HODO-2224-3+HODO-2224-6	Candesartan/Rosuvastatin/Ezetimibe	Oral tablet, QD

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
change of other Lipid profile	0, 4, 8 weeks	change of other Lipid profile