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NCT06174766CompletedPhase 3

A Study to Evaluate Efficacy and Safety of HGP2304 in Essential Hypertension Patients

A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate Efficacy and Safety of HGP2304 in Patients With Essential Hypertension

Source: ClinicalTrials.gov · Last updated 31 Aug 2026

Brief summary (registry, in English)

A multicenter, randomized, double-blind, phase III study to evaluate efficacy and safety of HGP2304 in patients with essential hypertension

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
356 (actual)
First submitted
8 Dec 2023
Start date
10 May 2024
Primary completion date
8 Jan 2026
Lead sponsor
Hanmi Pharmaceutical Company Limited
NCT number
NCT06174766

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 356
  • From 10 May 2024 to the primary completion date, 8 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Secondary hypertension patient or suspected to be
  • Severe heart disease or severe neurovascular disease
  • Moderate or malignant retinopathy
  • History of malignancy tumor
  • History of alcohol or drug abuse

Lab values

  • Uncontrolled type II diabetes mellitus (HbA1c \> 9%) or type I diabetes mellitus
  • Severe renal diseases (eGFR\<30mL/min/1.73m2)
  • Severe or active hepatopathy (AST or ALT ≥ 2 times of normal range)

Other

  • Difference between arms greater than 20 mmHg for mean sitSBP or 10mmHg for mean sitDBP at Visit 1
  • Hypokalemia or Hyperkalemia (K\<3.5mmol/L or K ≥ 5.5mmol/L)
  • Hyponatremia or Hypernatremia (Na\<135mmol/L or Na ≥ 155mmol/L)
  • Positive to pregnancy test, nursing mother, intention on pregnancy
  • Considered by investigator as not appropriate to participate in the clinical study with other reason

Who the study is looking for

  • 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
  • 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

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Severance hosptal
Coordinator of this site? Confirm its status
Seodaemun-guSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.