A Study to Evaluate Efficacy and Safety of HGP2102 in Essential Hypertension Patients

Hypertension Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HGP2102 in Patients With Essential Hypertension

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06174766
• Other study ID #: HM-ENCORE-301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• 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 the Efficacy and Safety of HGP2102 in patients with Essential Hypertension

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 324
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Subjects whose clinic blood pressure measured in visit 1 corresponds to the following conditions

• sitSBP<180 mmHg and sitDBP<110mg for patients receiving any BP-lowering drug within 1 month prior to Visit 1

• 140mmHG=sitSBP<180mmHg and 60mmHg=sitDBP<110mmHg

2. Subjects whose clinic and ambulatory blood pressure measured in visit 2 corresponds to the following conditions

• 24h-ABPM: 130mmHg= SBP <170mmHg

• clinic BP: 140 mmHg = sitSBP < 180 mmHg and 60 mmHg = sitDBP < 110 mmHg

Exclusion Criteria:

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

2. Patients who have taken more than three components of Blood pressure medication within 3 months prior to Visit 1

3. Orthostatic hypotension with symptoms within 3 months prior to visit 1

4. Secondary hypertension patient or suspected to be

5. Uncontrolled type II diabetes mellitus (HbA1c > 9%) or type I diabetes mellitus

6. Severe heart disease or severe neurovascular disease

7. Moderate or malignant retinopathy

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

9. Severe or active hepatopathy (AST or ALT = 2 times of normal range)

10. Hypokalemia or Hyperkalemia (K<3.5mmol/L or K = 5.5mmol/L)

11. Hyponatremia or Hypernatremia (Na<135mmol/L or Na = 155mmol/L)

12. History of malignancy tumor

13. History of alcohol or drug abuse

14. Positive to pregnancy test, nursing mother, intention on pregnancy

15. Considered by investigator as not appropriate to participate in the clinical study with other reason

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• HGP2102-1
Test drug
• HGP2102-2
Test drug
• RLD2209-1
Control drug
• RLD2209-2
Control drug

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in 24 hours ambulatory systolic blood pressure		baseline, 10 weeks
Secondary	Change from baseline in 24 hours ambulatory systolic blood pressure		baseline, 4 weeks
Secondary	Change from baseline in 24 hours ambulatory diastolic blood pressure		baseline, 4 weeks, 10 weeks
Secondary	Change from baseline in 24 hours ambulatory pulse pressure		baseline, 4 weeks, 10 weeks
Secondary	Change from baseline in diurnal ambulatory systolic blood pressure		baseline, 4 weeks, 10 weeks
Secondary	Change from baseline in diurnal ambulatory diastolic blood pressure		baseline, 4 weeks, 10 weeks
Secondary	Change from baseline in diurnal ambulatory pulse pressure		baseline, 4 weeks, 10 weeks
Secondary	Change from baseline in nocturnal ambulatory systolic blood pressure		baseline, 4 weeks, 10 weeks
Secondary	Change from baseline in nocturnal ambulatory diastolic blood pressure		baseline, 4 weeks, 10 weeks
Secondary	Change from baseline in nocturnal ambulatory pulse pressure		baseline, 4 weeks, 10 weeks
Secondary	Change from baseline in sitting systolic blood pressure		baseline, 4 weeks, 10 weeks
Secondary	Change from baseline in sitting diastolic blood pressure		baseline, 4 weeks, 10 weeks
Secondary	Change from baseline in sitting pulse pressure		baseline, 4 weeks, 10 weeks
Secondary	Proportion of subjects achieving blood pressure control		baseline, 4 weeks, 10 weeks
Secondary	Blood pressure response rate		baseline, 4 weeks, 10 weeks