A Study to Evaluate the Efficacy and Safety of HCP2102 in Essential Hypertension Patients

• Status: Not yet recruiting
• Trial end date: 2023-10-31
• Target enrollment: 0
• Participant gender: All

Summary

A multicenter, randomized, double-blind, phase III study to evaluate the efficacy and safety of HCP2102 in patients with essential hypertension

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

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Criteria

Inclusion Criteria:

1. Patients aged ≥ 19 years

2. Patients who understands the process of clinical study and voluntarily signs a peer letter

3. Visit 1: A person whose blood pressure measured in visit 1 corresponds to the following conditions

• Blood pressure medication taken patients: 140mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg

• Blood pressure medication free patients: 160mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg

4. Visit 2: 140mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg

Exclusion Criteria:

1. Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP

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

3. Secondary hypertension patient or suspected to be

4. Uncontrolled diabetes mellitus(HbA1c > 9%) or type I diabetes mellitus

5. Active gout or hyperuricemia (uric acid ≥ 9mg/dL)

6. Severe heart disease or severe neurovascular disease

7. Severe or malignant retinopathy

8. Clinically significant hematological finding

9. Severe renal diseases (eGFR<30mL/min/1.73m2)

10. Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)

11. Hypokalemia or Hyperkalemia(K<3.5mmol/L or K ≥ 5.5mmol/L)

12. Hyponatremia or Hypernatremia(Na<135mmol/L or Na ≥ 155mmol/L)

13. Hypercalcemia(Ca ≥ 10.5mg/dL)

14. History of malignancy tumor

15. History of autoimmune disease

16. History of alcohol or drug abuse

17. Positive to pregnancy test, nursing mother, intention on pregnancy

18. Considered by investigator as not appropriate to participate in the clinical study with other reason