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Clinical Efficacy and Safety Evaluation of HCP1904-1 in Essential Hypertension Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Clinical Efficacy and Safety Evaluation of HCP1904-1 in Essential Hypertension Patients

A Multi-center, Randomized, Double-blinded, Active-Controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of HCP1904-1 in Essential Hypertension Patients.

NCT04820907•Hanmi Pharmaceutical Company Limited

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate of efficacy and safety of HCP1904-1 and RLD2001-1 alone in patients with essential hypertension inadequately controlled on RLD2001-1 monotherapy.

Detailed Description

A Multi-center, Randomized, Double-blinded, Active-controlled, Parallel, Phse III Study to Evaluate the Efficacy and Safety of HCP1904-1 in Essential Hypertension Patients

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients over 18 years of age
•2. Patients who understands the process of clinical study and voluntarily signs a peer letter
•3. Visit1: A person whose blood pressure measured in visit1 corresponds to the following conditions
•* Blood pressure medication taken patients: 130mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg
•* Blood pressure medication free patients: 140mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg
•4. Visit2: 140mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg or if patients are in high risk group: 130mmHg ≤ sitSBP \<180mmHg, sit DBP \< 110mmHg

Exclusion Criteria

•Difference in mean value of blood pressure measured in both arms of more than 20mmHg in sitSBP or more than 10mmHg in sitDBP
•Orthostatic hypotension with symptoms within 3months of visit 1
•Secondary hypertensive patient or suspected to be
•Uncontrolled diabetes mellitus(HbA1c \> 9%) or type I diabetes mellitus
•Active gout or hyperuricemia (uric acid ≥ 9mg/dL)
•Severe heart disease or severe neurovascular disease
•Severe or malignant retinopathy
•Clinically significant hematological finding
•Severe renal diseases (eGFR\<30mL/min/1.73m2)
•Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
+8 more criteria

Locations (1)

Severance Hospital

Seoul, South Korea

Key Dates

Start Date

October 27, 2020

Primary Completion Date

September 30, 2021

Completion Date

September 30, 2021

Last Updated

September 22, 2023

Enrollment

123

ACTUAL participants

Conditions

Hypertension

Interventions

HCP1904-1

DRUG

RLD2001-1

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Clinical Efficacy and Safety Evaluation of HCP1904-1 in Essential Hypertension Patients

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

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