A Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension

A multicenter, randomized, double-blind, phase III study to evaluate efficacy and safety of HCP1803-4 in patients with essential hypertension

Inclusion criteria

• 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

Exclusion criteria

• Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
• 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
• Secondary hypertensive patient or suspected to be
• Clinically significant hematological finding
• Severe heart disease or severe neurovascular disease
• Moderate or malignant retinopathy
• Uncontrolled diabetes mellitus or type I diabetes mellitus
• Active gout or hyperuricemia
• Severe renal diseases
• Severe or active hepatopathy
• Hypokalemia or Hyperkalemia
• Hyponatremia or Hypernatremia
• 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 other reason