Actively Recruiting
A Study to Evaluate Efficacy and Safety of HGP2102 in Essential Hypertension Patients
Led by Hanmi Pharmaceutical Company Limited · Updated on 2025-06-12
324
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate the Efficacy and Safety of HGP2102 in patients with Essential Hypertension
CONDITIONS
Official Title
A Study to Evaluate Efficacy and Safety of HGP2102 in Essential Hypertension Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects with clinic systolic blood pressure (sitSBP) less than 180 mmHg and diastolic blood pressure (sitDBP) less than 110 mmHg if receiving any blood pressure-lowering drugs within 1 month prior to Visit 1
- Subjects with clinic blood pressure between 140 mmHg and less than 180 mmHg systolic and 60 mmHg and less than 110 mmHg diastolic
- Subjects with 24-hour ambulatory systolic blood pressure between 130 mmHg and less than 170 mmHg
- Subjects whose blood pressure meets above criteria at Visit 2
You will not qualify if you...
- Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg 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 or suspicion of it
- Uncontrolled type II diabetes (HbA1c > 9%) or type I diabetes mellitus
- Severe heart disease or severe neurovascular disease
- Moderate or malignant retinopathy
- Severe kidney disease (eGFR < 30 mL/min/1.73 m2)
- Severe or active liver disease (AST or ALT ≥ 2 times normal range)
- Low or high potassium levels (K < 3.5 mmol/L or K ≥ 5.5 mmol/L)
- Low or high sodium levels (Na < 135 mmol/L or Na ≥ 155 mmol/L)
- History of cancer
- History of alcohol or drug abuse
- Positive pregnancy test, nursing mother, or planning pregnancy
- Any other reason investigator considers participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sevrance hosptal
Seodaemun-gu, Seoul, South Korea, 03722
Actively Recruiting
Research Team
N
Na Young Kim
CONTACT
S
Seok Min Kang, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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