A Study to Evaluate Efficacy and Safety of HGP2304 in Essential Hypertension Patients

Korábbi kezelés

• Patients who have taken more than three components of Blood pressure medication within 3 months prior to Visit 1
• Orthostatic hypotension with symptoms within 3 months prior to visit 1

Más betegség

• Secondary hypertension patient or suspected to be
• Severe heart disease or severe neurovascular disease
• Moderate or malignant retinopathy
• History of malignancy tumor
• History of alcohol or drug abuse

Laborértékek

• Uncontrolled type II diabetes mellitus (HbA1c > 9%) or type I diabetes mellitus
• Severe renal diseases (eGFR<30mL/min/1.73m2)
• Severe or active hepatopathy (AST or ALT ≥ 2 times of normal range)

Egyéb

• Difference between arms greater than 20 mmHg for mean sitSBP or 10mmHg for mean sitDBP at Visit 1
• Hypokalemia or Hyperkalemia (K<3.5mmol/L or K ≥ 5.5mmol/L)
• Hyponatremia or Hypernatremia (Na<135mmol/L or Na ≥ 155mmol/L)
• Positive to pregnancy test, nursing mother, intention on pregnancy
• Considered by investigator as not appropriate to participate in the clinical study with other reason

• Subjects whose clinic blood pressure measured in visit 1 corresponds to the following conditions
  • sitSBP < 180 mmHg and sitDBP < 110mg for patients receiving any BP-lowering drug within 1 month prior to Visit 1
  • 140mmHg ≤ sitSBP < 180mmHg and 60mmHg ≤ sitDBP < 110mmHg
• Subjects whose clinic and ambulatory blood pressure measured in visit 2 corresponds to the following conditions
  • 24h-ABPM: 130mmHg ≤ SBP < 170mmHg
  • clinic BP: 140 mmHg ≤ sitSBP < 180 mmHg and 60 mmHg ≤ sitDBP < 110 mmHg