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

Launched by HANMI PHARMACEUTICAL COMPANY LIMITED · May 27, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new medication called HCP1803 to see how well it works in lowering blood pressure compared to another medication known as RLD2001-1. The study is for adults who have essential hypertension, which means their blood pressure is consistently high without any other obvious cause. If you are between the ages of 18 and 80, and your blood pressure readings are within certain limits, you might be eligible to participate. Specifically, participants should have a systolic blood pressure (the top number) between 140 and 180 mmHg and a diastolic blood pressure (the bottom number) between 60 and 110 mmHg.

If you join the study, you will be randomly assigned to receive either HCP1803 or RLD2001-1, and neither you nor the researchers will know which one you are getting (this is called a double-blind study). Throughout the trial, you'll have regular check-ups to monitor your blood pressure and overall health. It's important to know that there are some health conditions that would prevent you from participating, such as certain heart diseases, diabetes, or severe kidney issues. Overall, this trial aims to find a safe and effective treatment for people with high blood pressure, and your participation could contribute to important medical research.

Gender

ALL

Eligibility criteria

• 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

Trial Officials