EUCTR2005-004579-39-IT进行中（未招募）不适用
An eight-week, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of the combination of aliskiren / HCTZ (300/12.5 mg and 300/25 mg) in comparison with aliskiren 300 mg in patients with essential hypertension not adequately responsive to aliskiren 300 mg monotherapy - ND
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 792
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. Outpatients 18 years of age and older. 2. Male or female patients are eligible. 3. Patients with a diagnosis of hypertension: ? Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP sup/uguale a 95 mmHg and < 110 mmHg at Visit 1. ? All patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP sup/uguale a 85 mmHg and < 110 mmHg at Visit 2. ? All patients must have a msDBP sup/uguale a 90 mmHg and < 110 mmHg at Visit 4.
- •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
- •1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>= 5 mIU/ml). 2. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception such as surgical sterilization (e.g., bilateral tubal ligation) and hormonal contraception (implantable, patch, oral). Reliable contraception should be maintained throughout the study and for 7 days after medication discontinuation. 3. Severe hypertension (msDBP >= 110 mmHg and/or msSBP >= 180 mmHg). 4. History or evidence of a secondary form of hypertension. 5. Known Keith-Wagener grade III or IV hypertensive retinopathy. 6. Previous or current diagnosis of heart failure. 7. History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI). 8. Serum potassium < 3.5 mEq/L (mmol/L) or >= 5.3 mEq/L (mmol/L), serum sodium less than the lower limit of normal or dehydration. 9. Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled based on the investigator?s clinical judgment. Patients with diabetes mellitus enrolled in this study should be well controlled. It is recommended that patients currently being treated for diabetes mellitus be on a stable dose of oral antidiabetic medication for at least 4 weeks prior to Visit 1. 10. Current angina pectoris requiring pharmacological therapy. 11. Second or third degree heart block without a pacemaker. 12. Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening or any symptomatic arrhythmia during the 12 months prior to Visit 1. 13. Clinically significant valvular heart disease.(please see protocol)
研究者
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