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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Drug: HGP2102-1; Drug: HGP2102-2; Drug: RLD2209-1; Drug: RLD2209-2

• Study Type: Interventional
• Enrollment (Estimated): 324
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Na Young Kim; Phone Number: 82-2-410-9165; Email: skyko7@hanmi.co.kr
• Study Contact Backup: Name: Seok Min Kang, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental1; Take HGP2102-1 once daily for 4 weeks orally, and then take HGP2102-2 once daily for 6 weeks orally.	Drug: HGP2102-1; Test drug; Drug: HGP2102-2; Test drug
Experimental: Experimental2; Take HGP2102-1 once daily for 10 weeks orally.	Drug: HGP2102-1; Test drug
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; Control drug; Drug: RLD2209-2; Control drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in 24 hours ambulatory systolic blood pressure	baseline, 10 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change from baseline in diurnal ambulatory pulse pressure	baseline, 4 weeks, 10 weeks
Change from baseline in nocturnal ambulatory systolic blood pressure	baseline, 4 weeks, 10 weeks
Change from baseline in nocturnal ambulatory diastolic blood pressure	baseline, 4 weeks, 10 weeks
Change from baseline in nocturnal ambulatory pulse pressure	baseline, 4 weeks, 10 weeks
Change from baseline in sitting systolic blood pressure	baseline, 4 weeks, 10 weeks
Change from baseline in sitting diastolic blood pressure	baseline, 4 weeks, 10 weeks
Change from baseline in sitting pulse pressure	baseline, 4 weeks, 10 weeks
Proportion of subjects achieving blood pressure control	baseline, 4 weeks, 10 weeks
Blood pressure response rate	baseline, 4 weeks, 10 weeks

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Estimated): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: HM-ENCORE-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No