EUCTR2005-000450-75-DE进行中（未招募）不适用
Add-on Study of Olmesartan Medoxomil in Patients with Moderate to Severe Hypertension not Achieving Target Blood Pressure on Amlodipine 5 mg Alone
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 632
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female patients aged 18 years or older.
- •Patients with moderate to severe hypertension defined as mean sitting sBP 160 mmHg, mean sitting dBP 100 mmHg and a mean 24-hour dBP, assessed by 24hour-ABPM, of at least 84 mmHg and with at least 30% of daytime dBP readings over 90 mmHg at Visit 2 (i.e. prior to monotherapy treatment) will enter Period I.
- •Eligible patients who at Screening are already taking a stable dose of AML 5 mg or AML 10 mg for at least four weeks have to fulfil the following criteria before entering directly into Period I:
- •- previously suffered from moderate to severe hypertension (before first intake of
- •AML 5 mg or AML 10 mg)
- •- mean sitting sBP 140 mmHg and mean sitting dBP 90 mmHg at Screening
- •- a mean 24-hour dBP, assessed by 24hour-ABPM, of at least 80 mmHg and with at
- •least 30% of daytime dBP readings over 85 mmHg (at Visit 2).
- •To be randomised, the mean sitting trough dBP must be between 90 and 115 mmHg inclusive and the mean sitting trough systolic blood pressure (sPB) must be 140 mmHg (at Visit 4, conventional BP measurement). Furthermore, the mean 24-hour dBP, assessed by 24hour-ABPM, must be at least 80 mmHg and at least 30% of daytime dBP readings must be over 85 mmHg on monotherapy with amlodipine 5 mg.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Female patients of childbearing potential must not be pregnant or lactating.
- •- Patients with serious disorders which may limit the ability to evaluate the efficacy
- •or safety of the test drug(s), including cerebrovascular, cardiovascular, renal,
- •pulmonary, hepatic, gastrointestinal, endocrine/metabolic, haematological/onco-
- •logical, neurological and psychiatric diseases.
- •- Patients with poorly controlled diabetes mellitus.
- •- Patients having a history of the following within the last six months: myocardial
- •infarction, unstable angina pectoris, percutaneous coronary intervention, heart
- •failure, cerebrovascular accident, congestive heart failure, or transient ischaemic
- •- Patients with clinically significant elevations in laboratory values at Screening.
- •- Patients with secondary hypertension of any aetiology, such as renal disease,
- •pheochromocytoma, or Cushing’s syndrome.
- •- Patients with contraindications to olmesartan medoxomil, amlodipine besilate
- •and/or hydrochloro-thiazide.
研究者
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