Clinical Efficacy and Safety Evaluation of HCP1904-1 in Essential Hypertension Patients

Hanmi Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: RLD2001-1; Drug: HCP1904-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT04820907

HM-CHORUS-301

Details and patient eligibility

About

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

Full description

A Multi-center, Randomized, Double-blinded, Active-controlled, Parallel, Phse III Study to Evaluate the Efficacy and Safety of HCP1904-1 in Essential Hypertension Patients

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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123 participants in 2 patient groups

HCP1904-1

Experimental group

Treatment:

Drug: HCP1904-1

RLD2001-1

Active Comparator group

Treatment:

Drug: RLD2001-1