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Recruiting Phase 3 NCT06174766

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

Trial Parameters

Condition Hypertension
Sponsor Hanmi Pharmaceutical Company Limited
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 324
Sex ALL
Min Age 19 Years
Max Age N/A
Start Date 2024-05-10
Completion 2026-12-31
Interventions
HGP2102-1HGP2102-2RLD2209-1

Brief Summary

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

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 neurov

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