Status:
RECRUITING
A Study to Evaluate Efficacy and Safety of HGP2102 in Essential Hypertension Patients
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Hypertension
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate the Efficacy and Safety of HGP2102 in patients with Essential Hypertension
Eligibility Criteria
Inclusion
- 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
- 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
- Difference between arms greater than 20 mmHg for mean sitSBP or 10mmHg for mean sitDBP at Visit 1
- Patients who have taken more than three components of Blood pressure medication within 3 months prior to Visit 1
- Orthostatic hypotension with symptoms within 3 months prior to visit 1
- Secondary hypertension patient or suspected to be
- Uncontrolled type II diabetes mellitus (HbA1c \> 9%) or type I diabetes mellitus
- Severe heart disease or severe neurovascular disease
- Moderate or malignant retinopathy
- Severe renal diseases (eGFR\<30mL/min/1.73m2)
- Severe or active hepatopathy (AST or ALT ≥ 2 times of normal range)
- Hypokalemia or Hyperkalemia (K\<3.5mmol/L or K ≥ 5.5mmol/L)
- Hyponatremia or Hypernatremia (Na\<135mmol/L or Na ≥ 155mmol/L)
- History of malignancy tumor
- History of alcohol or drug abuse
- Positive to pregnancy test, nursing mother, intention on pregnancy
- Considered by investigator as not appropriate to participate in the clinical study with other reason
Key Trial Info
Start Date :
May 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT06174766
Start Date
May 10 2024
End Date
December 31 2026
Last Update
June 12 2025
Active Locations (1)
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1
Sevrance hosptal
Seodaemun-gu, Seoul, South Korea, 03722