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Study of the Efficacy and Safety of LCZ696 Alone and in Combination With Amlodipine in Patients With Hypertension

4 августа 2014 г. обновлено: Novartis Pharmaceuticals

An 8-week Randomized, Double-blind, Placebo-controlled Factorial Study to Evaluate the Efficacy and Safety of LCZ696 Alone and in Combination With Amlodipine in Patients With Essential Hypertension

To evaluate the blood pressure lowering effect and safety of LCZ696 when given alone and in combination with amlodipine in patients with essential hypertension.

Обзор исследования

Статус

Отозван

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Фаза

  • Фаза 3

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  1. Male or female outpatients
  2. Patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy
  3. Treated patients (using antihypertensive treatments within 4 weeks prior to Visit 1) must have an msSBP ≥150 mmHg and <180 mmHg at the randomization visit and msSBP ≥140 mmHg <180 mmHg at the preceding visit.
  4. Untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to Visit 1) must have an msSBP ≥150 mmHg and <180 mmHg at both the randomization visit and the preceding visit.
  5. Patients must have an absolute difference of ≤15 mmHg in msSBP between the randomization visit and the preceding visit.
  6. Ability to communicate and comply with all study requirements and demonstrate good medication compliance (≥ 80% compliance rate) during the treatment run-in period.

Exclusion Criteria:

  1. Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
  2. History of angioedema, drug-related or otherwise
  3. History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension
  4. Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke
  5. History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1
  6. Pregnant or lactating women
  7. Women of child-bearing potential not using highly effective methods of contraception Other protocol defined inclusion/exclusion criteria may apply

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: LCZ696 200 mg
Patients randomized to this treatment arm will receive LCZ696 200 mg once daily for 8 weeks.
Лекарство: LCZ696
Experimental monotherapy doses
Экспериментальный: LCZ696 400 mg
Patients randomized to this treatment arm will receive LCZ696 400 mg once daily for 8 weeks.
Лекарство: LCZ696
Experimental monotherapy doses
Активный компаратор: Amlodipine 5 mg
Patients randomized to this treatment arm will receive amlodipine 5 mg once daily for 8 weeks.
Лекарство: Amlodipine
Active comparator monotherapy doses
Активный компаратор: Amlodipine 10 mg
Patients randomized to this treatment arm will receive amlodipine 10 mg once daily for 8 weeks.
Лекарство: Amlodipine
Active comparator monotherapy doses
Экспериментальный: LCZ696 200 mg and amlodipine 5 mg
Patients randomized to this treatment arm will receive LCZ696 200 mg and amlodipine 5 mg once daily for 8 weeks.
Лекарство: LCZ696 and amlodipine combination
Experimental combination doses
Экспериментальный: LCZ696 200 mg and amlodipine 10 mg
Patients randomized to this treatment arm will receive LCZ696 200 mg and amlodipine 5 mg once daily for 1 week followed by LCZ696 200 mg and amlodipine 10 mg once daily for 7 weeks.
Лекарство: LCZ696 and amlodipine combination
Experimental combination doses
Экспериментальный: LCZ696 400 mg and amlodipine 5 mg
Patients randomized to this treatment arm will receive LCZ696 200 mg and amlodipine 5 mg once daily for 1 week followed by LCZ696 400 mg and amlodipine 5 mg once daily for 7 weeks.
Лекарство: LCZ696 and amlodipine combination
Experimental combination doses
Экспериментальный: LCZ696 400 mg and amlodipine 10 mg
Patients randomized to this treatment arm will receive LCZ696 200 mg and amlodipine 5 mg once daily for 1 week followed by LCZ696 400 mg and amlodipine 10 mg once daily for 7 weeks.
Лекарство: LCZ696 and amlodipine combination
Experimental combination doses
Плацебо Компаратор: Placebo
Patients randomized to this treatment arm will receive placebo once daily for 8 weeks.
Лекарство: Placebo
Placebo comparator dose

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change from baseline in mean sitting systolic blood pressure (msSBP) of LCZ696 monotherapy compared to placebo
Временное ограничение: baseline, 8 weeks
Sitting blood pressure will be measured at trough (immediately prior to dosing at clinic) and recorded at all study visits. At the first study visit, blood pressure will be measured in both arms and the arm with highest sitting SBP will be found and used for all subsequent readings throughout the study. The 4 repeat sitting measurements will be made at 2 minute intervals and the mean of these four sitting systolic blood pressure measurements will be used as the mean sitting systolic blood pressure for that visit.
baseline, 8 weeks
Change from baseline in mean sitting systolic blood pressure (msSBP) of the combination of LCZ696 and amlodipine compared to LCZ696 and amlodipine alone.
Временное ограничение: baseline, 8 weeks
Sitting blood pressure will be measured at trough (immediately prior to dosing at clinic) and recorded at all study visits. The 4 repeat sitting measurements will be made at 2 minute intervals and the mean of these four sitting systolic blood pressure measurements will be used as the mean sitting systolic blood pressure for that visit.
baseline, 8 weeks

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change from baseline in mean sitting Diastolic Blood Pressure (msDBP) of LCZ696 monotherapy compared to placebo
Временное ограничение: baseline, 8 weeks
Sitting blood pressure will be measured at trough (immediately prior to dosing at clinic) and recorded at all study visits. The 4 repeat sitting measurements will be made at 2 minute intervals and the mean of these four sitting diastolic blood pressure measurements will be used as the mean sitting diastolic blood pressure for that visit.
baseline, 8 weeks
Change from baseline in mean sitting Diastolic Blood Pressure of the combination of LCZ696 and amlodipine compared to LCZ696 and amlodipine alone
Временное ограничение: baseline, 8 weeks
Sitting blood pressure will be measured at trough (immediately prior to dosing at clinic) and recorded at all study visits. The 4 repeat sitting measurements will be made at 2 minute intervals and the mean of these four sitting diastolic blood pressure measurements will be used as the mean sitting diastolic blood pressure for that visit.
baseline, 8 weeks
Change from baseline in pulse pressure
Временное ограничение: baseline, 8 weeks
Pulse pressure will be calculated as the difference between msSBP and msDBP for both office BP and ABPM.
baseline, 8 weeks
Change from baseline in mean 24-hour ambulatory Systolic Blood Pressure of LCZ696 monotherapy compared to placebo
Временное ограничение: baseline, 8 weeks
The ABPM cuff will be placed on the non-dominant arm between approximately 7:00 am and 11:00 am and the device will measure blood pressure 3 times per hour for 24 hours.
baseline, 8 weeks
Change from baseline in mean 24-hour ambulatory Diastolic Blood Pressure of LCZ696 monotherapy compared to placebo
Временное ограничение: baseline, 8 weeks
The ABPM cuff will be placed on the non-dominant arm between approximately 7:00 am and 11:00 am and the device will measure blood pressure 3 times per hour for 24 hours.
baseline, 8 weeks
Change from baseline in mean daytime ( > 6am and ≤ 10 pm) ambulatory Systolic Blood Pressure of LCZ696 monotherapy compared to placebo
Временное ограничение: baseline, 8 weeks
The ABPM cuff will be placed on the non-dominant arm between approximately 7:00 am and 11:00 am and the device will measure blood pressure 3 times per hour for 24 hours.
baseline, 8 weeks
Change from baseline in mean daytime ( > 6am and ≤ 10 pm) ambulatory Diastolic Blood Pressure of LCZ696 monotherapy compared to placebo
Временное ограничение: baseline, 8 weeks
The ABPM cuff will be placed on the non-dominant arm between approximately 7:00 am and 11:00 am and the device will measure blood pressure 3 times per hour for 24 hours.
baseline, 8 weeks
Change from baseline in mean nighttime (> 10 pm and ≤ 6 am) ambulatory Systolic Blood Pressure of LCZ696 monotherapy compared to placebo
Временное ограничение: baseline, 8 weeks
The ABPM cuff will be placed on the non-dominant arm between approximately 7:00 am and 11:00 am and the device will measure blood pressure 3 times per hour for 24 hours.
baseline, 8 weeks
Change from baseline in mean nighttime (> 10 pm and ≤ 6 am) ambulatory Diastolic Blood Pressure of LCZ696 monotherapy compared to placebo
Временное ограничение: baseline, 8 weeks
The ABPM cuff will be placed on the non-dominant arm between approximately 7:00 am and 11:00 am and the device will measure blood pressure 3 times per hour for 24 hours.
baseline, 8 weeks
Change from baseline in trough to peak ratio of mean 24-hour ambulatory Systolic Blood Pressure of LCZ696 monotherapy compared to placebo
Временное ограничение: baseline, 8 weeks
The trough to peak ratio of mean 24-hour ambulatory Systolic Blood Pressure will be calculated using the systolic blood pressure effects at trough (post-dosing hour 24) compared to the maximum systolic blood pressure effect found in the hours after dosing.
baseline, 8 weeks
Change from baseline in trough to peak ratio of mean 24-hour ambulatory Diastolic Blood Pressure of LCZ696 monotherapy compared to placebo
Временное ограничение: baseline, 8 weeks
The trough to peak ratio of mean 24-hour ambulatory Diastolic Blood Pressure will be calculated using the diastolic blood pressure effects at trough (post-dosing hour 24) compared to the maximum diastolic blood pressure effect found in the hours after dosing.
baseline, 8 weeks
Change from baseline in mean 24-hour ambulatory Systolic Blood Pressure of the combination of LCZ696 and amlodipine compared to LCZ696 and amlodipine alone
Временное ограничение: baseline, 8 weeks
The ABPM cuff will be placed on the non-dominant arm between approximately 7:00 am and 11:00 am and the device will measure blood pressure 3 times per hour for 24 hours.
baseline, 8 weeks
Change from baseline in mean 24-hour ambulatory Diastolic Blood Pressure of the combination of LCZ696 and amlodipine compared to LCZ696 and amlodipine alone
Временное ограничение: baseline, 8 weeks
The ABPM cuff will be placed on the non-dominant arm between approximately 7:00 am and 11:00 am and the device will measure blood pressure 3 times per hour for 24 hours.
baseline, 8 weeks
Change from baseline in mean daytime ( > 6am and ≤ 10 pm) ambulatory Systolic Blood Pressure of the combination of LCZ696 and amlodipine compared to LCZ696 and amlodipine alone
Временное ограничение: baseline, 8 weeks
The ABPM cuff will be placed on the non-dominant arm between approximately 7:00 am and 11:00 am and the device will measure blood pressure 3 times per hour for 24 hours.
baseline, 8 weeks
Change from baseline in mean daytime ( > 6am and ≤ 10 pm) ambulatory Diastolic Blood Pressure of the combination of LCZ696 and amlodipine compared to LCZ696 and amlodipine alone
Временное ограничение: baseline, 8 weeks
The ABPM cuff will be placed on the non-dominant arm between approximately 7:00 am and 11:00 am and the device will measure blood pressure 3 times per hour for 24 hours.
baseline, 8 weeks
Change from baseline in mean nighttime (> 10 pm and ≤ 6 am) ambulatory Systolic Blood Pressure of the combination of LCZ696 and amlodipine compared to LCZ696 and amlodipine alone
Временное ограничение: baseline, 8 weeks
The ABPM cuff will be placed on the non-dominant arm between approximately 7:00 am and 11:00 am and the device will measure blood pressure 3 times per hour for 24 hours.
baseline, 8 weeks
Change from baseline in mean nighttime (> 10 pm and ≤ 6 am) ambulatory Diastolic Blood Pressure of the combination of LCZ696 and amlodipine compared to LCZ696 and amlodipine alone
Временное ограничение: baseline, 8 weeks
The ABPM cuff will be placed on the non-dominant arm between approximately 7:00 am and 11:00 am and the device will measure blood pressure 3 times per hour for 24 hours.
baseline, 8 weeks
Percentage of patients achieving msSBP <140 mmHg and msDBP <90 mmHg
Временное ограничение: 8 weeks
The percentage of patients achieving blood pressure control (msSBP <140 mmHg and msDBP <90 mmHg) after 8 weeks of treatment will be calculated.
8 weeks
Percentage of patients achieving msSBP <140 mmHg or a reduction ≥20 mmHg from baseline
Временное ограничение: Baseline, 8 weeks
The percentage of patients achieving a successful response in msSBP (msSBP <140 mmHg or a reduction ≥20 mmHg from baseline) after 8 weeks of treatment will be calculated.
Baseline, 8 weeks
Percentage of patients achieving msDBP <90 mmHg or a reduction ≥10 mmHg from baseline
Временное ограничение: Baseline, 8 weeks
The percentage of patients achieving a successful response in msSBP (msDBP <90 mmHg or a reduction ≥10 mmHg from baseline) after 8 weeks of treatment will be calculated.
Baseline, 8 weeks
Number of patients reporting adverse events
Временное ограничение: 8 weeks
As an assessment of safety of monotherapy and combination therapy of LCZ696, total adverse events, serious adverse events and deaths after 8 weeks of treatment will be reported .
8 weeks

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Novartis Pharmaceuticals

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 апреля 2014 г.

Первичное завершение (Ожидаемый)

1 апреля 2015 г.

Завершение исследования (Ожидаемый)

1 апреля 2015 г.

Даты регистрации исследования

Первый отправленный

24 мая 2013 г.

Впервые представлено, что соответствует критериям контроля качества

24 мая 2013 г.

Первый опубликованный (Оценивать)

30 мая 2013 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

5 августа 2014 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

4 августа 2014 г.

Последняя проверка

1 августа 2014 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • CLCZ696A2320
  • 2013-001643-30 (Номер EudraCT)

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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