A Study to Evaluate Efficacy and Safety of HGP2102 in Essential Hypertension Patients

Hanmi Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Hypertension

Treatments: Drug: RLD2209-1; Drug: HGP2102-2; Drug: HGP2102-1; Drug: RLD2209-2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06174766

HM-ENCORE-301

Details and patient eligibility

About

A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate the Efficacy and Safety of HGP2102 in patients with Essential Hypertension

Enrollment: 324 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects whose clinic blood pressure measured in visit 1 corresponds to the following conditions

   • sitSBP<180 mmHg and sitDBP<110mg for patients receiving any BP-lowering drug within 1 month prior to Visit 1
   • 140mmHG≤sitSBP<180mmHg and 60mmHg≤sitDBP<110mmHg

2. Subjects whose clinic and ambulatory blood pressure measured in visit 2 corresponds to the following conditions

   • 24h-ABPM: 130mmHg≤ SBP <170mmHg
   • clinic BP: 140 mmHg ≤ sitSBP < 180 mmHg and 60 mmHg ≤ sitDBP < 110 mmHg

Exclusion criteria

1. Difference between arms greater than 20 mmHg for mean sitSBP or 10mmHg for mean sitDBP at Visit 1
2. Patients who have taken more than three components of Blood pressure medication within 3 months prior to Visit 1
3. Orthostatic hypotension with symptoms within 3 months prior to visit 1
4. Secondary hypertension patient or suspected to be
5. Uncontrolled type II diabetes mellitus (HbA1c > 9%) or type I diabetes mellitus
6. Severe heart disease or severe neurovascular disease
7. Moderate or malignant retinopathy
8. Severe renal diseases (eGFR<30mL/min/1.73m2)
9. Severe or active hepatopathy (AST or ALT ≥ 2 times of normal range)
10. Hypokalemia or Hyperkalemia (K<3.5mmol/L or K ≥ 5.5mmol/L)
11. Hyponatremia or Hypernatremia (Na<135mmol/L or Na ≥ 155mmol/L)
12. History of malignancy tumor
13. History of alcohol or drug abuse
14. Positive to pregnancy test, nursing mother, intention on pregnancy
15. 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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324 participants in 3 patient groups

Experimental1

Experimental group

Description:

Take HGP2102-1 once daily for 4 weeks orally, and then take HGP2102-2 once daily for 6 weeks orally.

Treatment:

Drug: HGP2102-1

Drug: HGP2102-2

Experimental2

Experimental group

Description:

Take HGP2102-1 once daily for 10 weeks orally.

Treatment:

Drug: HGP2102-1

Active Comparator

Active Comparator group

Description:

Take RLD2209-1 once daily for 4 weeks orally, and then take RLD2209-2 once daily for 6 weeks orally.

Treatment:

Drug: RLD2209-2

Drug: RLD2209-1