A Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension

Hanmi Pharmaceutical Company Limited248 enrolled

Overview

A multicenter, randomized, double-blind, parallel, phase 2 study to assess dose-response relationship of HCP1803 in patients with essential hypertension

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

248

Conditions

Hypertension

Interventions

HCP1803DRUG

HCP1803

AmlodipineDRUG

Amlodipine

LosartanDRUG

Losartan

PlaceboDRUG

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with essential hypertension who meet 140 mmHg ≤ mean sitSBP \< 180 mmHg and mean sitDBP \< 110 mmHg at Visit 1, Visit 2 Exclusion Criteria: * Patient with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1 * Patient with difference of ≥ 15 mmHg in mean sitSBP between Visit 1 and Visit 2 * Patient with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg at Visit 1, Visit 2 * Patient with secondary hypertension

Locations (1)

Donggguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Change from baseline in sitting systolic blood pressure

Time frame: baseline, 8 weeks

Secondary Outcomes

Change from baseline in sitting systolic blood pressure

Time frame: baseline, 4 weeks

Change from baseline in sitting distolic blood pressure

Time frame: baseline, 4 weeks, 8 weeks

Proportion of subjects achieving blood pressure control

sitSBP/sitDBP \< 140/90 mmHg

Time frame: 4 weeks, 8 weeks

Proportion of responder

Change from baseline in sitSBP/sitDBP ≥ 20/10 mmHg

Time frame: baseline, 4 weeks, 8 weeks

Change from baseline in pulse pressure(sitSBP - sitDBP)

Time frame: baseline, 4 weeks, 8 weeks

Data from ClinicalTrials.gov

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