A Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605

Hanmi Pharmaceutical Company Limited340 enrolled

Overview

A phase 3 study to evaluate efficacy and safety of HCP1401

A randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of HCP1401 for stage 2 hypertension patients not controlled by HCP0605

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

340

Conditions

Hypertension

Interventions

HCP1401DRUG

amlodipine, Losartan, Chlorthalidone FDC

HCP0605DRUG

amlodipine, Losartan FDC

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hypertension patient who satisfied below condition at Visit 1. * patient who takes antihypertensive drug * 140mmHg \<= sitSBP \<= 200mmHg * patient who doesn't take antihypertensive drug * 160mmHg \<= sitSBP \<= 200mmHg * 140mmHg \<= sitSBP \<= 200mmHg at Visit 2 Exclusion Criteria: * Patient who have received 4 or more antihypertensive drug * Patient with 20mmHg of difference in sitSBP or 10mmHg of difference in sitDBP between 3 times of BP measuring at Visit 1 * Patient with sitDBP \>= 120mmHg at Visit 2 * Patient with secondary hypertension

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Change from baseline in sitting systolic blood pressure at week 8

Time frame: 8 weeks

Secondary Outcomes

Change from baseline in sitting diastolic blood pressure at week 2 and week 8

Time frame: 2 weeks and 8 weeks

Change from baseline in sitting systolic blood pressure at week 2

Time frame: 2 weeks

Proportion of subjects achieving Blood Pressure control

Time frame: 2 weeks and 8 weeks

Data from ClinicalTrials.gov

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