Clinical Efficacy and Safety Evaluation of HCP1904-3 in Essential Hypertension Patients

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: HCP1904-3; Drug: RLD2001-1

• Registration Number: NCT05199129
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

The purpose of this study is to evaluate of efficacy and safety of HCP1904-3 and RLD2001-1 alone in patients with essential hypertension inadequately controlled on RLD2001-1 monotherapy.

Detailed Description

A Multi-center, Randomized, Double-blinded, Active-Controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of HCP1904-3 in Essential Hypertension patients

Study Timeline

• Study Start: 2021-11-17
• Study First Submitted: 2022-01-06
• Study First Submitted QC: 2022-01-06
• Study First Posted: 2022-01-20
• Primary Completion: 2022-09-14
• Study Completion: 2022-09-14
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

1. Patients over 19 years of age

2. Patients who understands the process of clinical study and voluntarily signs a peer letter

3. Visit1: A person whose blood pressure measured in visit1 corresponds to the following conditions

   • Blood pressure medication taken patients: 130mmHg ≤ sitSBP<180mmHg, sitDBP<110mmHg
   • Blood pressure medication free patients: 140mmHg ≤ sitSBP<180mmHg, sitDBP<110mmHg

4. Visit2: 140mmHg ≤ sitSBP<180mmHg, sitDBP<110mmHg or if patients are in high risk group: 130mmHg ≤ sitSBP <180mmHg, sit DBP < 110mmHg

Exclusion Criteria

1. Difference in mean value of blood pressure measured in both arms of more than 20mmHg in sitSBP or more than 10mmHg in sitDBP
2. Orthostatic hypotension with symptoms within 3months of 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. Severe or malignant retinopathy
8. Clinically significant hematological finding
9. Severe renal diseases (eGFR<30mL/min/1.73m2)
10. Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
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 othe reason

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HCP1904-3	HCP1904-3	-
HCP1904-3	RLD2001-1	-
RLD2001-1	HCP1904-3	-
RLD2001-1	RLD2001-1	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in mean sitting systolic blood pressure(mmHg)	Week 8

Secondary Outcome Measures

Name	Time	Method
Change from baseline in mean sitting systolic blood pressure(mmHg)	Week 4
Change from baseline in mean sitting diastolic blood pressure(mmHg)	Week 4,8
Change from baseline in mean pulse blood pressure(mmHg)	Week 4,8
Target blood pressure reach rate(%)	Week 4,8
Blood pressure responder rate(%)	Week 4,8

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of