A Study to Evaluate Efficacy and Safety of HCP1803 Compared to RLD2001-1 in Patients with Essential Hypertension

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: RLD2001-1; Drug: HCP1803-3; Drug: HPP2003-3; Drug: HPP2002-1

• Registration Number: NCT06438172
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HCP1803 compared to RLD2001-1 in patients with essential hypertension

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-25
• Study First Submitted: 2024-05-27
• Study First Submitted QC: 2024-05-27
• Study First Posted: 2024-05-31
• Primary Completion: 2024-12-02
• Study Completion: 2024-12-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-16
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

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. Orthostatic hypotension with symptoms within 3 months prior to visit 1.
3. Secondary hypertensive patient or suspected to be
4. Uncontrolled diabetes mellitus(HbA1c > 9%) or type I diabetes mellitus
5. Active gout or hyperuricemia (uric acid ≥ 9mg/dL)
6. Severe heart disease or severe neurovascular disease
7. Moderate or malignant retinopathy
8. Clinically significant hematological finding
9. Severe renal diseases (eGFR<30mL/min/1.73m2)
10. Severe or active hepatopathy (AST or ALT ≥ 3 times of normal range)
11. Hypokalemia or Hyperkalemia(K<3.5mmol/L or K ≥ 5.5mmol/L)
12. Hyponatremia or Hypernatremia(Na<135mmol/L or Na ≥ 155mmol/L)
13. Hypercalcemia
14. History of malignancy tumor
15. History of autoimmune disease
16. History of alcohol or drug abuse
17. Positive to pregnancy test, nursing mother, intention on pregnancy
18. Considered by investigator as not appropriate to participate in the clinical study with other reason

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator	RLD2001-1	RLD2001-1
Active Comparator	HPP2003-3	RLD2001-1
Experimental	HCP1803-3	HCP1803-3
Experimental	HPP2002-1	HCP1803-3

Primary Outcome Measures

Name	Time	Method
Change from baseline in sitting systolic blood pressure	baseline, 8 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in pulse pressure	baseline, 4 weeks, 8 weeks
Change from baseline in sitting systolic blood pressure	baseline, 4 weeks
Proportion of subjects achieving blood pressure control	4 weeks, 8 weeks
Change from baseline in sitting distolic blood pressure	baseline, 4 weeks, 8 weeks
Blood pressure response rate	4 weeks, 8 weeks
Treatment response rate	4 weeks, 8 weeks

Trial Locations

Locations (1)

Donggguk University Ilsan Hospital; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of