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A Study to Evaluate the Efficacy and Safety of HCP2102 in Essential Hypertension Patients | Clinical Trials | Clareo Health

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A Study to Evaluate the Efficacy and Safety of HCP2102 in Essential Hypertension Patients

A Multicenter, Randomized, Doube-blind, Phase III Study to Evaluate the Efficacy and Safety of HCP2102 in Patients With Essential Hypertension

NCT05450601•Hanmi Pharmaceutical Company Limited

View on ClinicalTrials.gov

Summary

A multicenter, randomized, double-blind, phase III study to evaluate the efficacy and safety of HCP2102 in patients with essential hypertension

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients aged ≥ 19 years
•2. Patients who understands the process of clinical study and voluntarily signs a peer letter
•3. Visit 1: A person whose blood pressure measured in visit 1 corresponds to the following conditions
•* Blood pressure medication taken patients: 140mmHg ≤ sitSBP\<200mmHg, sitDBP\<120mmHg
•* Blood pressure medication free patients: 160mmHg ≤ sitSBP\<200mmHg, sitDBP\<120mmHg
•4. Visit 2: 140mmHg ≤ sitSBP\<200mmHg, sitDBP\<120mmHg

Exclusion Criteria

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

Locations (1)

Kyung Hee University Hospital

Seoul, South Korea

Key Dates

Start Date

September 1, 2022

Primary Completion Date

December 11, 2023

Completion Date

December 11, 2023

Last Updated

March 5, 2024

Enrollment

249

ACTUAL participants

Conditions

Hypertension

Interventions

HCP2102-1

DRUG

HPP2104-1

DRUG

HCP2102-2

DRUG

HPP2104-2

DRUG

RLD2106-1

DRUG

HPP2103-1

DRUG

RLD2106-2

DRUG

HPP2103-2

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITING

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

NCT07480265

Hypertension (HTN)Hyperhomocysteinemia+1 more

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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: March 5, 2024Data 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.

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A Study to Evaluate the Efficacy and Safety of HCP2102 in Essential Hypertension Patients

Inclusion Criteria

Exclusion Criteria

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