A Study to Evaluate Efficacy and Safety of HCP1803 Compared to RLD2001-1 in Patients With Essential Hypertension

Hypertension Clinical Trial

— HM_APOLLO  

Official title:

A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate Efficacy and Safety of HCP1803 Compared to RLD2001-1 in Patients With Essential Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06438172
• Other study ID #: HM-APOLLO-302
• Status: Recruiting
• Phase: Phase 3
• Start date: March 25, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Hanmi Pharmaceutical Company Limited
• Contact: Na Young Kim
• Phone: 82-2-410-9165
• Email: skyko7[@]hanmi.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HCP1803 compared to RLD2001-1 in patients with essential hypertension

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. 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

2. Patients with essential hypertension who meet 140 mmHg = mean sitSBP < 180 mmHg and 60 mmHg = mean sitDBP < 110 mmHg at Visit 2

Exclusion Criteria:

1. Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1

2. Orthostatic hypotension with symptoms within 3 months prior to 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. Moderate or malignant retinopathy

8. Clinically significant hematological finding

9. Severe renal diseases (eGFR<30mL/min/1.73m2)

10. Severe or active hepatopathy (AST or ALT = 3 times of normal range)

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 other reason

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• HCP1803-3
Take it once daily for 8 weeks orally.
• RLD2001-1
Take it once daily for 8 weeks orally.
• HPP2003-3
Placebo drug. Take it once daily for 8 weeks orally.
• HPP2002-1
Placebo drug. Take it once daily for 8 weeks orally.

Locations

Country	Name	City	State
Korea, Republic of	Donggguk University Ilsan Hospital	Goyang-si	Gyeonggi-do

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 sitting systolic blood pressure		baseline, 8 weeks
Secondary	Change from baseline in sitting systolic blood pressure		baseline, 4 weeks
Secondary	Change from baseline in sitting distolic blood pressure		baseline, 4 weeks, 8 weeks
Secondary	Proportion of subjects achieving blood pressure control		4 weeks, 8 weeks
Secondary	Blood pressure response rate		4 weeks, 8 weeks
Secondary	Treatment response rate		4 weeks, 8 weeks
Secondary	Change from baseline in pulse pressure		baseline, 4 weeks, 8 weeks