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Completed

NCT Number: NCT06174766

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

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sevrance hosptal

Seodaemun-gu, Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

HGP2102-1

Drug

Test drug

HGP2102-2

Drug

Test drug

RLD2209-1

Drug

Control drug

RLD2209-2

Drug

Control drug

Primary outcomes

  1. Change from baseline in 24 hours ambulatory systolic blood pressure

    Time frame: baseline, 10 weeks

Secondary outcomes

  1. Change from baseline in 24 hours ambulatory systolic blood pressure

    Time frame: baseline, 4 weeks

  2. Change from baseline in 24 hours ambulatory diastolic blood pressure

    Time frame: baseline, 4 weeks, 10 weeks

  3. Change from baseline in 24 hours ambulatory pulse pressure

    Time frame: baseline, 4 weeks, 10 weeks

  4. Change from baseline in diurnal ambulatory systolic blood pressure

    Time frame: baseline, 4 weeks, 10 weeks

  5. Change from baseline in diurnal ambulatory diastolic blood pressure

    Time frame: baseline, 4 weeks, 10 weeks

  6. Change from baseline in diurnal ambulatory pulse pressure

    Time frame: baseline, 4 weeks, 10 weeks

  7. Change from baseline in nocturnal ambulatory systolic blood pressure

    Time frame: baseline, 4 weeks, 10 weeks

  8. Change from baseline in nocturnal ambulatory diastolic blood pressure

    Time frame: baseline, 4 weeks, 10 weeks

  9. Change from baseline in nocturnal ambulatory pulse pressure

    Time frame: baseline, 4 weeks, 10 weeks

  10. Change from baseline in sitting systolic blood pressure

    Time frame: baseline, 4 weeks, 10 weeks

  11. Change from baseline in sitting diastolic blood pressure

    Time frame: baseline, 4 weeks, 10 weeks

  12. Change from baseline in sitting pulse pressure

    Time frame: baseline, 4 weeks, 10 weeks

  13. Proportion of subjects achieving blood pressure control

    Time frame: baseline, 4 weeks, 10 weeks

  14. Blood pressure response rate

    Time frame: baseline, 4 weeks, 10 weeks

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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