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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: HPP2002-1; Drug: HCP1803-3; Drug: RLD2001-1; Drug: HPP2003-3

Study type: Interventional

Funder types: Industry

Identifiers

NCT06438172

HM-APOLLO-302

Details and patient eligibility

About

A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HCP1803 compared to RLD2001-1 in patients with essential hypertension

Enrollment: 249 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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249 participants in 2 patient groups

Experimental

Experimental group

Description:

HCP1803-3

Treatment:

Drug: HCP1803-3

Drug: HPP2002-1

Active Comparator

Active Comparator group

Description:

RLD2001-1

Treatment:

Drug: HPP2003-3

Drug: RLD2001-1