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

Hyundai Pharmaceutical

Status and phase: Invitation-only; Phase 3

Conditions: Hypertension; Primary Hypercholesterolaemia

Treatments: Drug: Ezetimibe/Rosuvastatin/Candesartan/Amlodipine; Drug: Candesartan/Rosuvastatin/Ezetimibe; Drug: Candesartan/Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06646354

HD_CARE_002

Details and patient eligibility

About

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

Full 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.

Enrollment: 125 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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125 participants in 3 patient groups

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

Experimental group

Description:

Oral tablet, QD

Treatment:

Drug: Ezetimibe/Rosuvastatin/Candesartan/Amlodipine

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

Active Comparator group

Description:

Oral tablet, QD

Treatment:

Drug: Candesartan/Amlodipine

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

Active Comparator group

Description:

Oral tablet, QD

Treatment:

Drug: Candesartan/Rosuvastatin/Ezetimibe