EUCTR2008-002797-36-SK进行中（未招募）1 期
A twenty-four week, open-label, non-comparative, multicenter study to assess the efficacy and tolerability of an aliskiren-based treatment algorithm in patients with mild to moderate hypertension.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 230
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
- •1. Patients who are eligible and able to participate in the study and who provide written informed consent to do so after the purpose and nature of investigation has been clearly explained to them.
- •2. Male or female outpatients, 18 years of age or older.
- •3. Patients with a diagnosis of mild to moderate hypertension at visit 1 (defined as msSBP = 140 mmHg and < 180 mmHg and/or msDBP = 90 and < 110 mmHg).
- •4. All patients must have a msSBP = 140 mmHg and < 180 mmHg and/or msDBP = 90 and < 110 mmHg at Visit 3.
- •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
- •For full list, please refer to the protocol.
- •1. Severe hypertension defined as msSBP = 180 mmHg and/or msDBP = 110 mmHg at any visit.
- •2. History or evidence of secondary hypertension of any etiology (e.g., untreated renal artery stenosis, pheochromocytoma).
- •3. Current diagnosis of heart failure (NYHA class II-IV).
- •4. Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates).
- •5. Second or third degree heart block without a pacemaker.
- •6. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial
- •fibrillation or atrial flutter, during the 12 months prior to Visit 1.
- •7. Clinically significant valvular heart disease.
- •8. History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, coronary bypass surgery, myocardial infarction or any percutaneous coronary intervention (PCI).
- •9. Known Keith-Wagener grade III or IV hypertensive retinopathy.
- •10. History of angioedema due to ACEI and/or ARB administration.
- •11. For patients with mild hypertension, an antihypertensive therapy regimen that includes more than one class of medication prior to Visit 1. (It means that patients on a fixed dose combination antihypertensive therapy that include two or more classes are considered to take two or more antihypertensive medications and therefore cannot be enrolled in the study)
- •12. For patients with moderate hypertension, the antihypertensive therapy that includes more than two classes of medication prior to Visit 1.
- •13. Patients with Type 1 diabetes mellitus.
- •14. Patients with Type 2 diabetes mellitus who are not well controlled based on
- •investigator’s judgment. Patients currently being treated for diabetes mellitus must have satisfactory metabolic control. Type 2 diabetic patients taking oral antidiabetics must be on stable dose for at least 4 weeks prior to Visit 1.
- •15. Serum sodium less than the lower limit of normal, serum potassium < 3.5 mEq/L
- •(corresponding to 3.5 mmol/L) or = 5.3 mEq/L (corresponding to 5.3 mmol/L), or
- •dehydration at Visit 1.
研究者
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