A Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension

Официальное название

A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension

Обзор

A Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension

Подробное описание

A multicenter, randomized, double-blind, phase III study to evaluate efficacy and safety of HCP1803-4 in patients with essential hypertension

Вмешательства

• Препарат HCP1803-3
  Test drug
• Препарат HCP1803-4
  Test drug
• Препарат RLD2001-1
  Control drug
• Препарат RLD2001-2
  Control drug

Первичные конечные точки

• Change from baseline in sitting systolic blood pressure [Срок оценки: Baseline, 10 weeks]

Вторичные конечные точки (8)

• Change from baseline in sitting systolic blood pressure [Срок оценки: Baseline, 2 weeks, 6 weeks]
• Change from baseline in sitting diastolic blood pressure [Срок оценки: Baseline, 2 weeks, 6 weeks, 10 weeks]
• Proportion of subjects achieving blood pressure control (sitSBP) [Срок оценки: 2 weeks, 6 weeks, 10 weeks]
• Proportion of subjects achieving blood pressure control (sitSBP, sitDBP) [Срок оценки: 2 weeks, 6 weeks, 10 weeks]
• Blood pressure response rate (sitSBP) [Срок оценки: 2 weeks, 6 weeks, 10 weeks]
• Blood pressure response rate (sitSBP, sitDBP) [Срок оценки: 2 weeks, 6 weeks, 10 weeks]
• Treatment response rate [Срок оценки: 2 weeks, 6 weeks, 10 weeks]
• Change from baseline in pulse pressure [Срок оценки: Baseline, 2 weeks, 6 weeks, 10 weeks]

Критерии участия

Критерии включения

• Patients with essential hypertension whose blood pressure measured in visit1 corresponds to the following conditions

• mean sitSBP < 180 mmHg and mean sitDBP < 110 mmHg for patients receiving any BP-lowering drug within 1 month prior to Visit 1
• 140 mmHg ≤ mean sitSBP < 180 mmHg and 60 mmHg ≤ mean sitDBP < 110 mmHg for patients not receiving BP-lowering drugs within 1 month prior to Visit 1
• Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP < 180 mmHg and 60 mmHg ≤ mean sitDBP < 110 mmHg at Visit 2

Критерии исключения

• Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg 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 hypertensive patient or suspected to be
• Clinically significant hematological finding
• Severe heart disease or severe neurovascular disease
• Moderate or malignant retinopathy
• Uncontrolled diabetes mellitus or type I diabetes mellitus
• Active gout or hyperuricemia
• Severe renal diseases
• Severe or active hepatopathy
• Hypokalemia or Hyperkalemia
• Hyponatremia or Hypernatremia
• Hypercalcemia
• History of malignancy tumor
• History of autoimmune disease
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Donggguk University Ilsan Hospital — Goyang-si

Идентификаторы

NCT: NCT07660796 · HM-APOLLO-303

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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