Status:
COMPLETED
Clinical Efficacy and Safety Evaluation of HCP1904-3 in Essential Hypertension Patients
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Hypertension
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate of efficacy and safety of HCP1904-3 and RLD2001-1 alone in patients with essential hypertension inadequately controlled on RLD2001-1 monotherapy.
Detailed Description
A Multi-center, Randomized, Double-blinded, Active-Controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of HCP1904-3 in Essential Hypertension patients
Eligibility Criteria
Inclusion
- Patients over 19 years of age
- Patients who understands the process of clinical study and voluntarily signs a peer letter
- Visit1: A person whose blood pressure measured in visit1 corresponds to the following conditions
- Blood pressure medication taken patients: 130mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg
- Blood pressure medication free patients: 140mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg
- Visit2: 140mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg or if patients are in high risk group: 130mmHg ≤ sitSBP \<180mmHg, sit DBP \< 110mmHg
Exclusion
- Difference in mean value of blood pressure measured in both arms of more than 20mmHg in sitSBP or more than 10mmHg in sitDBP
- Orthostatic hypotension with symptoms within 3months of 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
- Severe or malignant retinopathy
- Clinically significant hematological finding
- Severe renal diseases (eGFR\<30mL/min/1.73m2)
- Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
- 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 othe reason
Key Trial Info
Start Date :
November 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2022
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT05199129
Start Date
November 17 2021
End Date
September 14 2022
Last Update
September 22 2023
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea, 03722