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

NCT07660796 | Not Yet Recruiting Phase 3

• 1 other identifier: HM-APOLLO-303
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in sitting systolic blood pressure

  Baseline, 10 weeks

Secondary Outcomes (8)

• 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

Study Arms (2)

HCP1803-4

EXPERIMENTAL

Take HCP1803-3 once daily for 2 weeks orally, and then take HCP1803-4 once daily for 8 weeks orally.

Drug: HCP1803-3; Drug: HCP1803-4

RLD2001-2

ACTIVE COMPARATOR

Take RLD2001-1 once daily for 2 weeks orally, and then take RLD2001-2 once daily for 8 weeks orally.

Drug: RLD2001-1; Drug: RLD2001-2

Interventions

HCP1803-3 DRUG

Test drug

HCP1803-4

HCP1803-4 DRUG

Test drug

HCP1803-4

RLD2001-1 DRUG

Control drug

RLD2001-2

RLD2001-2 DRUG

Control drug

RLD2001-2

Eligibility Criteria

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

You may qualify if:

• 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
• 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
• Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP \< 180 mmHg and 60 mmHg ≤ mean sitDBP \< 110 mmHg at Visit 2

You may not qualify if:

• Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg 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 hypertensive patient or suspected to be
• Clinically significant hematological finding
• Severe heart disease or severe neurovascular disease
• Moderate or malignant retinopathy
• Uncontrolled diabetes mellitus or type I diabetes mellitus
• Active gout or hyperuricemia
• Severe renal diseases
• Severe or active hepatopathy
• Hypokalemia or Hyperkalemia
• Hyponatremia or Hypernatremia
• Hypercalcemia
• History of malignancy tumor

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Donggguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, 10326, South Korea

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Moo-Yong Rhee, M.D., Ph.D.

  Donggguk University Ilsan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jee Won Shon

CONTACT

+82-2-410-9037; jeewon.shon@hanmi.co.kr

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: June 16, 2026
• First Posted: June 22, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

KR (1)