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

Hanmi Pharmaceutical Company Limited started a new clinical trial "A Multi-center, Randomized, Double-blinded, Active-Controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of HCP1904-1 in Essential Hypertension Patients".

The company Hanmi Pharmaceutical Company Limited is enrolling patients into the clinical trial investigating Clinical Efficacy and Safety Evaluation of HCP1904-1 in Essential Hypertension Patients.

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.

The trial is designed to enroll male and female 18 Years and older and is being conducted in the Severance Hospital, Seoul, Korea, Republic of.

The study start date is August 4, 2020.

The patients that can be enrolled into this study include:

  • 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.

The population that are excluded from participation:

  • 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.

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT04820907

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