Status:
COMPLETED
A Study to Evaluate Efficacy and Safety of HCP1803 in Patients With Essential Hypertension
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Hypertension
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HCP1803 in patients with essential hypertension
Eligibility Criteria
Inclusion
- 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
- Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
- Orthostatic hypotension with symptoms within 3 months prior to visit 1.
- Secondary hypertensive patient or suspected to be
- Uncontrolled diabetes mellitus(HbA1c \> 9%) or type I diabetes mellitus
- Active gout or hyperuricemia (uric acid ≥ 9mg/dL)
- Severe heart disease or severe neurovascular disease
- Moderate or malignant retinopathy
- Clinically significant hematological finding
- Severe renal diseases (eGFR\<30mL/min/1.73m2)
- Severe or active hepatopathy (AST or ALT ≥ 3 times of normal range)
- Hypokalemia or Hyperkalemia(K\<3.5mmol/L or K ≥ 5.5mmol/L)
- Hyponatremia or Hypernatremia(Na\<135mmol/L or Na ≥ 155mmol/L)
- 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
Key Trial Info
Start Date :
May 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2023
Estimated Enrollment :
361 Patients enrolled
Trial Details
Trial ID
NCT05362110
Start Date
May 16 2022
End Date
June 5 2023
Last Update
September 26 2023
Active Locations (1)
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1
Donggguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea, 10326