Observational Study to Evaluate the Efficacy of OLMETEC Tab on Nocturnal Blood Pressure Control in Patients With Stage Ⅰ Hypertension
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Stage 1 Hypertension. Базовые параметры: от 19 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- South Korea
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Prospective, Multi-Center, Observational Study to Evaluate the Efficacy of OLMETEC Tab. (or OLMETEC Plus Tab.) on Nocturnal Blood Pressure Control in Korean Patients With Stage Ⅰ Hypertension
Обзор
This is a prospective, multicenter, observational study to evaluate the effectiveness of Olmetec® or Olmetec Plus® on nocturnal blood pressure control in Korean patients with stage 1 hypertension. Patients receiving Olmetec-based therapy in routine clinical practice will be followed to assess changes in ambulatory blood pressure, including nocturnal blood pressure and blood pressure variability.
Подробное описание
This is a prospective, multicenter, observational study designed to evaluate the effectiveness of Olmetec® (olmesartan medoxomil) or Olmetec Plus® (olmesartan medoxomil/hydrochlorothiazide) on nocturnal blood pressure control in Korean patients with stage 1 hypertension.
In routine clinical practice, patients diagnosed with stage 1 hypertension and newly prescribed Olmetec® or Olmetec Plus® according to the approved label and the physician's clinical judgment will be enrolled and followed prospectively. No additional intervention beyond standard medical care will be applied.
Ambulatory blood pressure monitoring (ABPM) will be used to assess 24-hour blood pressure profiles, including nocturnal blood pressure, daytime blood pressure, and blood pressure variability. Measurements will be performed at baseline and after treatment to evaluate changes over time.
The primary objective of this study is to assess the change in mean systolic blood pressure from baseline to 12 weeks (up to 20 weeks). Secondary objectives include evaluation of diastolic blood pressure, nocturnal blood pressure, blood pressure variability, responder rate, and changes in dipping patterns. Safety will be assessed by monitoring adverse events during the study period.
This study aims to generate real-world evidence on the effectiveness and safety of Olmetec-based therapy in controlling nocturnal blood pressure and improving blood pressure variability in patients with stage 1 hypertension.
Первичные конечные точки
- Change in mean 24-hour systolic blood pressure [Срок оценки: Baseline to 12 weeks (up to 20 weeks)]
Вторичные конечные точки (10)
- Change in clinic systolic and diastolic blood pressure [Срок оценки: Baseline to 12 weeks (up to 20 weeks)]
- Responder rate [Срок оценки: At 12 weeks (up to 20 weeks)]
- Change in mean 24-hour diastolic blood pressure [Срок оценки: Baseline to 12 weeks (up to 20 weeks)]
- Change in nocturnal systolic and diastolic blood pressure [Срок оценки: Baseline to 12 weeks (up to 20 weeks)]
- Change in daytime systolic and diastolic blood pressure [Срок оценки: Baseline to 12 weeks (up to 20 weeks)]
- Change in blood pressure variability [Срок оценки: Baseline to 12 weeks (up to 20 weeks)]
- Change in dipping status (dipper/non-dipper proportion) [Срок оценки: Baseline to 12 weeks (up to 20 weeks)]
- Dipper conversion rate [Срок оценки: At 12 weeks (up to 20 weeks)]
- Change in morning blood pressure surge (MBPS) [Срок оценки: Baseline to 12 weeks (up to 20 weeks)]
- Change in pulse pressure [Срок оценки: Baseline to 12 weeks (up to 20 weeks)]
Критерии участия
Критерии включения
- Adults aged ≥19 years
- Patients diagnosed with stage 1 hypertension according to clinical guidelines
- Patients who are newly prescribed Olmetec® or Olmetec Plus® in routine -clinical practice
- Patients who are able to undergo ambulatory blood pressure monitoring (ABPM)
- Patients who voluntarily agree to participate and provide written informed consent
Критерии исключения
- Patients with secondary hypertension
- Patients with severe hypertension requiring immediate pharmacological i-ntervention
- Patients with known hypersensitivity to olmesartan medoxomil, hydrochlorothiazide, or any component of the study drugs
- Patients who are pregnant, planning to become pregnant, or breastfeeding
- Patients with severe renal impairment or severe hepatic impairment
- Patients who are unable to comply with study procedures, including ABPM
- Patients who are deemed inappropriate for participation by the investigator
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
South Korea · 1 центр
- Multiple centers in Republic of Korea — Seoul
Идентификаторы
NCT: NCT07515599 · DW_OMT_DB_01