Clinical Efficacy and Safety Evaluation of HCP1904-3 in Essential Hypertension Patients

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05199129
• Other study ID #: HM-CHORUS-303
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

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