A Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension

A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension

A Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Drug: HCP1803-3; Drug: HCP1803-4; Drug: RLD2001-1; Drug: RLD2001-2

Detailed Description

A multicenter, randomized, double-blind, phase III study to evaluate efficacy and safety of HCP1803-4 in patients with essential hypertension

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jee Won Shon; Phone Number: +82-2-410-9037; Email: jeewon.shon@hanmi.co.kr

Study Locations

• South Korea
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, South Korea, 10326
      • Donggguk University Ilsan Hospital
      • Contact: Moo-Yong Rhee, M.D., Ph.D.; Phone Number: +82-31-961-5775; Email: mooyong.rhee@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Patients with essential hypertension whose blood pressure measured in visit1 corresponds to the following conditions

   • mean sitSBP < 180 mmHg and mean sitDBP < 110 mmHg for patients receiving any BP-lowering drug within 1 month prior to Visit 1
   • 140 mmHg ≤ mean sitSBP < 180 mmHg and 60 mmHg ≤ mean sitDBP < 110 mmHg for patients not receiving BP-lowering drugs within 1 month prior to Visit 1
2. Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP < 180 mmHg and 60 mmHg ≤ mean sitDBP < 110 mmHg at Visit 2

Exclusion Criteria:

1. Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg 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 hypertensive patient or suspected to be
5. Clinically significant hematological finding
6. Severe heart disease or severe neurovascular disease
7. Moderate or malignant retinopathy
8. Uncontrolled diabetes mellitus or type I diabetes mellitus
9. Active gout or hyperuricemia
10. Severe renal diseases
11. Severe or active hepatopathy
12. Hypokalemia or Hyperkalemia
13. Hyponatremia or Hypernatremia
14. Hypercalcemia
15. History of malignancy tumor
16. History of autoimmune disease
17. History of alcohol or drug abuse
18. Positive to pregnancy test, nursing mother, intention on pregnancy
19. 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HCP1803-4; Take HCP1803-3 once daily for 2 weeks orally, and then take HCP1803-4 once daily for 8 weeks orally.	Drug: HCP1803-3; Test drug; Drug: HCP1803-4; Test drug
Active Comparator: RLD2001-2; Take RLD2001-1 once daily for 2 weeks orally, and then take RLD2001-2 once daily for 8 weeks orally.	Drug: RLD2001-1; Control drug; Drug: RLD2001-2; Control drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in sitting systolic blood pressure	Baseline, 10 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in sitting systolic blood pressure	Baseline, 2 weeks, 6 weeks
Change from baseline in sitting diastolic blood pressure	Baseline, 2 weeks, 6 weeks, 10 weeks
Proportion of subjects achieving blood pressure control (sitSBP)	2 weeks, 6 weeks, 10 weeks
Proportion of subjects achieving blood pressure control (sitSBP, sitDBP)	2 weeks, 6 weeks, 10 weeks
Blood pressure response rate (sitSBP)	2 weeks, 6 weeks, 10 weeks
Blood pressure response rate (sitSBP, sitDBP)	2 weeks, 6 weeks, 10 weeks
Treatment response rate	2 weeks, 6 weeks, 10 weeks
Change from baseline in pulse pressure	Baseline, 2 weeks, 6 weeks, 10 weeks

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Principal Investigator: Moo-Yong Rhee, M.D., Ph.D., Donggguk University Ilsan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 6, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: HM-APOLLO-303

Drug and device information, study documents

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