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NCT06174766 | RECRUITING | Hypertension

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

Hanmi Pharmaceutical Company Limited

Brief Summary:

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

Condition or disease

Hypertension

Intervention/treatment

HGP2102-1

HGP2102-2

RLD2209-1

RLD2209-2

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 324 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HGP2102 in Patients With Essential Hypertension
Actual Study Start Date : 2024-05-10
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Study to Evaluate Efficacy and Safety of HGP2102 in Essential Hypertension Patients

Location Details

NCT06174766

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How to Participate

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Locations

RECRUITING

South Korea, Seoul

Sevrance hosptal

From Seodaemun, Seoul, South Korea, 03722