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

Hypertension Clinical Trial

Official title:

A Multicenter, Randomized, Doube-blind, Phase III Study to Evaluate the Efficacy and Safety of HCP2102 in Patients With Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05450601
• Other study ID #: HM-ALCH-302
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2022
• Est. completion date: December 11, 2023

Study information

• Verified date: March 2024
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: December 11, 2023
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• HCP2102-1
Take once daily for 2 weeks orally
• HPP2104-1
Placebo drug. Take once daily for 2 weeks orally
• HCP2102-2
Take once daily for 6 weeks orally
• HPP2104-2
Placebo drug. Take once daily for 6 weeks orally
• RLD2106-1
Take once daily for 2 weeks orally
• HPP2103-1
Placebo drug. Take once daily for 2 weeks orally
• RLD2106-2
Take once daily for 6 weeks orally
• HPP2103-2
Placebo drug. Take once daily for 6 weeks orally

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University 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 2
Secondary	Change from baseline in mean sitting diastolic blood pressure(mmHg)		week 2, 8
Secondary	Change from baseline in mean pulse blood pressure(mmHg)		week 2, 8
Secondary	Target blood pressure reaching rate(%)		week 2, 8
Secondary	Blood pressure responder rate(%)		week 2, 8