Clinical trial NCT06438172: A Study to Evaluate Efficacy and Safety of HCP1803 Compared to RLD2001-1 in Patients with Essential Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2024-05-31
Enrollment: 249
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


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

Primary outcomes:
measure: Change from baseline in sitting systolic blood pressure
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: Change from baseline in sitting systolic blood pressure
timeFrame: baseline, 4 weeks
measure: Change from baseline in sitting distolic blood pressure
timeFrame: baseline, 4 weeks, 8 weeks
measure: Proportion of subjects achieving blood pressure control
timeFrame: 4 weeks, 8 weeks
measure: Blood pressure response rate
timeFrame: 4 weeks, 8 weeks
measure: Treatment response rate
timeFrame: 4 weeks, 8 weeks
measure: Change from baseline in pulse pressure
timeFrame: baseline, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Donggguk University Ilsan Hospital
state: Gyeonggi-do
Study officials:
affiliation: Donggguk University Ilsan Hospital
name: Moo-Yong Rhee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: