A Study to Evaluate Efficacy and Safety of HCP1803 in Patients With Essential Hypertension (HM_APOLLO)

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Hanmi Pharmaceutical

Status and phase

Completed
Phase 3

Conditions

Hypertension

Treatments

Drug: HPP2003-3
Drug: HPP2004
Drug: RLD2002
Drug: HCP1803-3

Study type

Interventional

Funder types

Industry

Identifiers

NCT05362110
HM-APOLLO-301

Details and patient eligibility

About

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

Enrollment

361 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
  • Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP < 180 mmHg and 60 mmHg ≤ mean sitDBP < 110 mmHg at Visit 2

Exclusion criteria

  • Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
  • Orthostatic hypotension with symptoms within 3 months prior to visit 1.
  • Secondary hypertensive patient or suspected to be
  • Uncontrolled diabetes mellitus(HbA1c > 9%) or type I diabetes mellitus
  • Active gout or hyperuricemia (uric acid ≥ 9mg/dL)
  • Severe heart disease or severe neurovascular disease
  • Moderate or malignant retinopathy
  • Clinically significant hematological finding
  • Severe renal diseases (eGFR<30mL/min/1.73m2)
  • Severe or active hepatopathy (AST or ALT ≥ 3 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)
  • Hypercalcemia
  • History of malignancy tumor
  • History of autoimmune disease
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

361 participants in 2 patient groups

Experimental
Experimental group
Description:
HCP1803-3
Treatment:
Drug: HCP1803-3
Drug: HPP2004
Active Comparator
Active Comparator group
Description:
RLD2002
Treatment:
Drug: RLD2002
Drug: HPP2003-3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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