A Study to Evaluate Efficacy and Safety of HCP1803 Compared to RLD2001-1 in Patients with Essential Hypertension

Korábbi kezelés

• Orthostatic hypotension with symptoms within 3 months prior to visit 1.

Más betegség

• Severe heart disease or severe neurovascular disease
• Moderate or malignant retinopathy
• History of malignancy tumor
• History of autoimmune disease
• History of alcohol or drug abuse

Laborértékek

• Uncontrolled diabetes mellitus(HbA1c > 9%) or type I diabetes mellitus
• Severe renal diseases (eGFR<30mL/min/1.73m2)
• Severe or active hepatopathy (AST or ALT ≥ 3 times of normal range)

Egyéb

• Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
• Secondary hypertensive patient or suspected to be
• Active gout or hyperuricemia (uric acid ≥ 9mg/dL)
• Clinically significant hematological finding
• Hypokalemia or Hyperkalemia(K<3.5mmol/L or K ≥ 5.5mmol/L)
• Hyponatremia or Hypernatremia(Na<135mmol/L or Na ≥ 155mmol/L)
• Hypercalcemia
• Positive to pregnancy test, nursing mother, intention on pregnancy
• Considered by investigator as not appropriate to participate in the clinical study with other reason

• Patients with essential hypertension whose blood pressure measured in visit1 corresponds to the following conditions
  • mean sitSBP <180 mmHg and mean sitDBP < 110 mmHg for patients receiving any BP-lowering drug within 1 month prior to Visit 1
  • 140 mmHg ≤ mean sitSBP < 180 mmHg and 60 mmHg ≤ mean sitDBP < 110 mmHg for patients not receiving BP-lowering drugs within 1 month prior to Visit 1
• Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP < 180 mmHg and 60 mmHg ≤ mean sitDBP < 110 mmHg at Visit 2