A Study to Evaluate the Efficacy and Safety of HCP2102 in Essential Hypertension Patients

Hanmi Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: RLD2106-2; Drug: HPP2104-2; Drug: HPP2104-1; Drug: HCP2102-1; Drug: HCP2102-2; Drug: RLD2106-1; Drug: HPP2103-2; Drug: HPP2103-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05450601

HM-ALCH-302

Details and patient eligibility

About

A multicenter, randomized, double-blind, phase III study to evaluate the efficacy and safety of HCP2102 in patients with essential hypertension

Enrollment: 249 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged ≥ 19 years

2. Patients who understands the process of clinical study and voluntarily signs a peer letter

3. Visit 1: A person whose blood pressure measured in visit 1 corresponds to the following conditions

   • Blood pressure medication taken patients: 140mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg
   • Blood pressure medication free patients: 160mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg

4. Visit 2: 140mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg

Exclusion criteria

1. Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
2. Orthostatic hypotension with symptoms within 3 months prior to visit 1
3. Secondary hypertension 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. Severe or malignant retinopathy
8. Clinically significant hematological finding
9. Severe renal diseases (eGFR<30mL/min/1.73m2)
10. Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
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(Ca ≥ 10.5mg/dL)
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:

HCP2102

Treatment:

Drug: HPP2104-2

Drug: HPP2104-1

Drug: HCP2102-2

Drug: HCP2102-1

Active Comparator

Active Comparator group

Description:

RLD2106

Treatment:

Drug: RLD2106-2

Drug: RLD2106-1

Drug: HPP2103-2

Drug: HPP2103-1