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

NCT ID: NCT06174766

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-10
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental1

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

Group Type: EXPERIMENTAL

HGP2102-1

Intervention Type: DRUG

Test drug

HGP2102-2

Intervention Type: DRUG

Test drug

Experimental2

Take HGP2102-1 once daily for 10 weeks orally.

Group Type: EXPERIMENTAL

HGP2102-1

Intervention Type: DRUG

Test drug

Active Comparator

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

Group Type: ACTIVE_COMPARATOR

RLD2209-1

Intervention Type: DRUG

Control drug

RLD2209-2

Intervention Type: DRUG

Control drug

Interventions

HGP2102-1

Test drug

Intervention Type: DRUG

HGP2102-2

Test drug

Intervention Type: DRUG

RLD2209-1

Control drug

Intervention Type: DRUG

RLD2209-2

Control drug

Intervention Type: DRUG

Eligibility Criteria

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)

11. Hyponatremia or Hypernatremia (Na<135mmol/L or Na ≥ 155mmol/L)

12. History of malignancy tumor

13. History of alcohol or drug abuse

14. Positive to pregnancy test, nursing mother, intention on pregnancy

15. Considered by investigator as not appropriate to participate in the clinical study with other reason

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sevrance hosptal

Seodaemun-gu, Seoul, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Na Young Kim

Role: CONTACT

skyko7@hanmi.co.kr

82-2-410-9165

Seok Min Kang, Ph.D

Role: CONTACT

Facility Contacts

Seokmin Kang, M.D., Ph.D.

Role: primary

smkang@yuhs.ac

82-2-2228-8450

Other Identifiers

HM-ENCORE-301

Identifier Type: -

Identifier Source: org_study_id