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RECRUITINGPHASE3

A Study to Evaluate Efficacy and Safety of HGP2102 in Essential Hypertension Patients

A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HGP2102 in Patients With Essential Hypertension

NCT06174766•Hanmi Pharmaceutical Company Limited

View on ClinicalTrials.gov

Summary

A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate the Efficacy and Safety of HGP2102 in patients with Essential Hypertension

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects whose clinic blood pressure measured in visit 1 corresponds to the following conditions
•* sitSBP\<180 mmHg and sitDBP\<110mg for patients receiving any BP-lowering drug within 1 month prior to Visit 1
•* 140mmHG≤sitSBP\<180mmHg and 60mmHg≤sitDBP\<110mmHg
•2. Subjects whose clinic and ambulatory blood pressure measured in visit 2 corresponds to the following conditions
•* 24h-ABPM: 130mmHg≤ SBP \<170mmHg
•* clinic BP: 140 mmHg ≤ sitSBP \< 180 mmHg and 60 mmHg ≤ sitDBP \< 110 mmHg

Exclusion Criteria

•1. Difference between arms greater than 20 mmHg for mean sitSBP or 10mmHg for mean sitDBP at Visit 1
•2. Patients who have taken more than three components of Blood pressure medication within 3 months prior to Visit 1
•3. Orthostatic hypotension with symptoms within 3 months prior to visit 1
•4. Secondary hypertension patient or suspected to be
•5. Uncontrolled type II diabetes mellitus (HbA1c \> 9%) or type I diabetes mellitus
•6. Severe heart disease or severe neurovascular disease
•7. Moderate or malignant retinopathy
•8. Severe renal diseases (eGFR\<30mL/min/1.73m2)
•9. Severe or active hepatopathy (AST or ALT ≥ 2 times of normal range)
•10. Hypokalemia or Hyperkalemia (K\<3.5mmol/L or K ≥ 5.5mmol/L)
+5 more criteria

Locations (1)

Sevrance hosptal

Seodaemun-gu, Seoul, South Korea

Key Dates

Start Date

May 10, 2024

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2026

Last Updated

June 12, 2025

Enrollment

324

ESTIMATED participants

Conditions

Hypertension

Interventions

HGP2102-1

DRUG

HGP2102-2

DRUG

RLD2209-1

DRUG

RLD2209-2

DRUG

Contacts

Na Young Kim

CONTACT

82-2-410-9165 skyko7@hanmi.co.kr

Seok Min Kang, Ph.D

CONTACT

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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: June 12, 2025Data 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 Efficacy and Safety of HGP2102 in Essential Hypertension Patients

Inclusion Criteria

Exclusion Criteria

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