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

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:

1. 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

2. Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP < 180 mmHg and 60 mmHg ≤ mean sitDBP < 110 mmHg at Visit 2

Exclusion Criteria:

1. Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
2. Patients who have taken more than three components of Blood pressure medication within 3 months prior to Visit 1
3. Orthostatic hypotension with symptoms within 3 months prior to visit 1
4. Secondary hypertensive patient or suspected to be
5. Clinically significant hematological finding
6. Severe heart disease or severe neurovascular disease
7. Moderate or malignant retinopathy
8. Uncontrolled diabetes mellitus or type I diabetes mellitus
9. Active gout or hyperuricemia
10. Severe renal diseases
11. Severe or active hepatopathy
12. Hypokalemia or Hyperkalemia
13. Hyponatremia or Hypernatremia
14. Hypercalcemia
15. History of malignancy tumor
16. History of autoimmune disease
17. History of alcohol or drug abuse
18. Positive to pregnancy test, nursing mother, intention on pregnancy
19. Considered by investigator as not appropriate to participate in the clinical study with other reason