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 3Enrolling By InvitationNCT06646354

Hyundai Pharm125 enrolled

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

125

Conditions

Hypertension Primary Hypercholesterolaemia

Interventions

Ezetimibe/Rosuvastatin/Candesartan/AmlodipineDRUG

PO, QD, 8 weeks

Candesartan/AmlodipineDRUG

PO, QD, 8 weeks

Candesartan/Rosuvastatin/EzetimibeDRUG

PO, QD, 8 weeks

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Hanyang University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Low density lipoprotein cholesterol (LDL-C)

LDL-C change at Week 8 compared HODO-2224-1 + HODO-2224-4 + HODO-2224-5 with HODO-2224

Time frame: baseline and week 8

Mean sitting systolic blood pressure (MSSBP)

MSSBP change at week 8 compared HODO-2224-2 + HODO-2224-3 + HODO-2224-6 with HODO-2224

Time frame: baseline and week 8

Secondary Outcomes

change of other Lipid profile

Time frame: 0, 4, 8 weeks

Data from ClinicalTrials.gov

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