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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05199129
Other study ID # HM-CHORUS-303
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 17, 2021
Est. completion date September 14, 2022

Study information

Verified date September 2023
Source Hanmi Pharmaceutical Company Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 166
Est. completion date September 14, 2022
Est. primary completion date September 14, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: 1. Patients over 19 years of age 2. Patients who understands the process of clinical study and voluntarily signs a peer letter 3. 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 4. Visit2: 140mmHg = sitSBP<180mmHg, sitDBP<110mmHg or if patients are in high risk group: 130mmHg = sitSBP <180mmHg, sit DBP < 110mmHg Exclusion Criteria: 1. Difference in mean value of blood pressure measured in both arms of more than 20mmHg in sitSBP or more than 10mmHg in sitDBP 2. Orthostatic hypotension with symptoms within 3months of visit 1 3. Secondary hypertensive 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 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 othe reason

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HCP1904-3
Take once daily for 8 weeks orally
RLD2001-1
Take once daily for 8 weeks orally

Locations

Country Name City State
Korea, Republic of Severance Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in mean sitting systolic blood pressure(mmHg) Week 8
Secondary Change from baseline in mean sitting systolic blood pressure(mmHg) Week 4
Secondary Change from baseline in mean sitting diastolic blood pressure(mmHg) Week 4,8
Secondary Change from baseline in mean pulse blood pressure(mmHg) Week 4,8
Secondary Target blood pressure reach rate(%) Week 4,8
Secondary Blood pressure responder rate(%) Week 4,8
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