Clinical Efficacy and Safety Evaluation of HCP1904-2 in Essential Hypertension Patients

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: HCP1904-2; Drug: RLD2001-2

• Registration Number: NCT04830449
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

The purpose of this study is to evaluate of efficacy and safety of HCP1904-2 and RLD2001-2 alone in patients with essential hypertension inadequately controlled on RLD2001-2 monotherapy.

Detailed Description

A Multi-center, Randomized, Double-blinded, Active-controlled, Parallel, Phse III Study to Evaluate the Efficacy and Safety of HCP1904-2 in Essential Hypertension Patients

Study Timeline

• Study Start: 2020-10-29
• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-05
• Primary Completion: 2021-08-24
• Study Completion: 2021-08-24
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

1. Patients over 18 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

• Difference in mean value of blood pressure measured in both arms of more than 20mmHg in sitSBP or more than 10mmHg in sitDBP
• Orthostatic hypotension with symptoms within 3months of visit 1
• Secondary hypertensive patient or suspected to be
• Uncontrolled diabetes mellitus(HbA1c > 9%) or type I diabetes mellitus
• Active gout or hyperuricemia (uric acid ≥ 9mg/dL)
• Severe heart disease or severe neurovascular disease
• Severe or malignant retinopathy
• Clinically significant hematological finding
• Severe renal diseases (eGFR<30mL/min/1.73m2)
• Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
• Hypokalemia or Hyperkalemia(K<3.5mmol/L or K ≥ 5.5mmol/L)
• Hyponatremia or Hypernatremia(Na<135mmol/L or Na ≥ 155mmol/L)
• Hypercalcemia
• History of malignancy tumor
• History of autoimmune disease
• History of alcohol or drug abuse
• Positive to pregnancy test, nursing mother, intention on pregnancy
• 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
HCP1904-2	HCP1904-2	-
RLD2001-2	RLD2001-2	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
target blood pressure reach rate	Week 4, 8
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
Responder rate	Week 4, 8

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of