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

• Status: Recruiting
• Trial end date: 2021-09-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Criteria

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