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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: HCP1904-3; Drug: RLD2001-1

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 Type: Interventional
• Enrollment (Actual): 166
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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
Active Comparator: RLD2001-1	Drug: HCP1904-3; Take once daily for 8 weeks orally; Drug: RLD2001-1; Take once daily for 8 weeks orally
Experimental: HCP1904-3	Drug: HCP1904-3; Take once daily for 8 weeks orally; Drug: RLD2001-1; Take once daily for 8 weeks orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in mean sitting systolic blood pressure(mmHg)	Week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Actual): September 14, 2022
• Study Completion (Actual): September 14, 2022

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Chlorthalidone; Losartan
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: HM-CHORUS-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