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

NCT06174766 | Recruiting Phase 3

• 1 other identifier: HM-ENCORE-301
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in 24 hours ambulatory systolic blood pressure

  baseline, 10 weeks

Secondary Outcomes (14)

• Change from baseline in 24 hours ambulatory systolic blood pressure

  baseline, 4 weeks

• Change from baseline in 24 hours ambulatory diastolic blood pressure

  baseline, 4 weeks, 10 weeks

• Change from baseline in 24 hours ambulatory pulse pressure

  baseline, 4 weeks, 10 weeks

• Change from baseline in diurnal ambulatory systolic blood pressure

  baseline, 4 weeks, 10 weeks

• Change from baseline in diurnal ambulatory diastolic blood pressure

  baseline, 4 weeks, 10 weeks

Study Arms (3)

Experimental1

EXPERIMENTAL

Take HGP2102-1 once daily for 4 weeks orally, and then take HGP2102-2 once daily for 6 weeks orally.

Drug: HGP2102-1; Drug: HGP2102-2

Experimental2

EXPERIMENTAL

Take HGP2102-1 once daily for 10 weeks orally.

Drug: HGP2102-1

Active Comparator

ACTIVE COMPARATOR

Take RLD2209-1 once daily for 4 weeks orally, and then take RLD2209-2 once daily for 6 weeks orally.

Drug: RLD2209-1; Drug: RLD2209-2

Interventions

HGP2102-1 DRUG

Test drug

Experimental1; Experimental2

HGP2102-2 DRUG

Test drug

Experimental1

RLD2209-1 DRUG

Control drug

Active Comparator

RLD2209-2 DRUG

Control drug

Active Comparator

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• mmHG≤sitSBP\<180mmHg and 60mmHg≤sitDBP\<110mmHg
• Subjects whose clinic and ambulatory blood pressure measured in visit 2 corresponds to the following conditions
• h-ABPM: 130mmHg≤ SBP \<170mmHg
• clinic BP: 140 mmHg ≤ sitSBP \< 180 mmHg and 60 mmHg ≤ sitDBP \< 110 mmHg

You may not qualify if:

• Difference between arms greater than 20 mmHg for mean sitSBP or 10mmHg for mean sitDBP at Visit 1
• Patients who have taken more than three components of Blood pressure medication within 3 months prior to Visit 1
• Orthostatic hypotension with symptoms within 3 months prior to visit 1
• Secondary hypertension patient or suspected to be
• Uncontrolled type II diabetes mellitus (HbA1c \> 9%) or type I diabetes mellitus
• Severe heart disease or severe neurovascular disease
• Moderate or malignant retinopathy
• Severe renal diseases (eGFR\<30mL/min/1.73m2)
• Severe or active hepatopathy (AST or ALT ≥ 2 times of normal range)
• Hypokalemia or Hyperkalemia (K\<3.5mmol/L or K ≥ 5.5mmol/L)
• Hyponatremia or Hypernatremia (Na\<135mmol/L or Na ≥ 155mmol/L)
• History of malignancy tumor
• History of alcohol or drug abuse
• Positive to pregnancy test, nursing mother, intention on pregnancy
• Considered by investigator as not appropriate to participate in the clinical study with other reason

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Sevrance hosptal

Seodaemun-gu, Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Na Young Kim

CONTACT

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

Seok Min Kang, Ph.D

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: May 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)