HGP2102 for adults with essential hypertension

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

This study tests whether HGP2102 can lower clinic and 24-hour ambulatory blood pressure in adults with essential hypertension.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 324 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Hanmi Pharmaceutical Company Limited (industry)
• Locations: 1 site (Seodaemun-gu, Seoul)
• Trial ID: NCT06174766 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind Phase 3 trial randomizes adults with essential hypertension to one of two doses of HGP2102 or matching doses of a reference drug (RLD2209). Eligible participants must meet clinic and 24-hour ambulatory BP ranges and will undergo clinic and ambulatory monitoring as part of the protocol. Key exclusions include secondary hypertension, uncontrolled diabetes (HbA1c > 9%), recent symptomatic orthostatic hypotension, severe heart disease, and recent use of more than three antihypertensive agents. The trial compares blood-pressure lowering effects and safety/tolerability between HGP2102 doses and the reference product using clinic and ambulatory BP measures and adverse event reporting.

Who should consider this trial

Good fit: Adults with essential hypertension who meet the clinic BP (SBP 140–179 mmHg, DBP 60–109 mmHg) and 24-hour ABPM SBP (130–169 mmHg) ranges and who do not have the specified exclusions may qualify.

Not a fit: Patients with secondary hypertension, uncontrolled diabetes (HbA1c > 9%), recent symptomatic orthostatic hypotension, severe heart disease, or those on more than three antihypertensive agents within three months are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, HGP2102 could provide an additional medication option to help lower blood pressure in patients with essential hypertension.

How similar studies have performed: While antihypertensive drug development has produced successful agents, the specific efficacy and safety of HGP2102 must still be demonstrated in this Phase 3 program.

Eligibility 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

Where this trial is running

Seodaemun-gu, Seoul

• Sevrance hosptal — Seodaemun-gu, Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Na Young Kim

Conditions: Hypertension