RecruitingPhase 3NCT06174766

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

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

Sponsor

Hanmi Pharmaceutical Company Limited

Enrollment

324 participants

Start Date

May 10, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 Years

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
mmHG≤sitSBP\<180mmHg and 60mmHg≤sitDBP\<110mmHg
Subjects whose clinic and ambulatory blood pressure measured in visit 2 corresponds to the following conditions
h-ABPM: 130mmHg≤ SBP \<170mmHg
clinic BP: 140 mmHg ≤ sitSBP \< 180 mmHg and 60 mmHg ≤ sitDBP \< 110 mmHg

Difference between arms greater than 20 mmHg for mean sitSBP or 10mmHg for mean sitDBP at Visit 1
Patients who have taken more than three components of Blood pressure medication within 3 months prior to Visit 1
Orthostatic hypotension with symptoms within 3 months prior to visit 1
Secondary hypertension patient or suspected to be
Uncontrolled type II diabetes mellitus (HbA1c \> 9%) or type I diabetes mellitus
Severe heart disease or severe neurovascular disease
Moderate or malignant retinopathy
Severe renal diseases (eGFR\<30mL/min/1.73m2)
Severe or active hepatopathy (AST or ALT ≥ 2 times of normal range)
Hypokalemia or Hyperkalemia (K\<3.5mmol/L or K ≥ 5.5mmol/L)
Hyponatremia or Hypernatremia (Na\<135mmol/L or Na ≥ 155mmol/L)
History of malignancy tumor
History of alcohol or drug abuse
Positive to pregnancy test, nursing mother, intention on pregnancy
Considered by investigator as not appropriate to participate in the clinical study with other reason