EUCTR2006-003629-98-DK进行中（未招募）1 期
A 54-week, open label, multi-center study to assess the long-term safety and tolerability of the combination of aliskiren 300 mg/ amlodipine 10 mg in patients with essential 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
- 500
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. For newly diagnosed/untreated patients with essential hypertension defined as
- •DBP > 90 and < 110 mmHg at Visit 1 and Visit 4.
- •4. For previously treated patients with essential hypertension defined as DBP = 90
- •and < 110 mmHg after 2 to 4 weeks of washout (Visits 3 or 4).
- •5. Patients who are eligible and able to participate in the study, and who consent to
- •do so after the purpose and nature of the investigation has been clearly
- •explained to them (written informed consent).
- •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 Protocol
- •1. Previously treated in an aliskiren study that contained the treatment group of the
- •combination of aliskiren and amlodipine and had been randomized or enrolled
- •into the active drug treatment period of that study.
- •2. Severe hypertension (msDBP >110 mmHg and/or msSBP > 180 mmHg)
- •3. Pregnant or nursing (lactating) women, where pregnancy is defined as a state of
- •a female after conception and until the termination of gestation, confirmed by a
- •positive hCG laboratory test (> 5 mIU/ml)
- •4. 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/ml or 6 weeks post surgical blilateral 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) or
- •hormonal contraception (implantable, patch, oral). Reliable contraception should
- •be maintained throughout the study and for 7 days after study medication
- •discontinuation.
- •5. History or evidence of a secondary form of hypertension
- •6. Any history of hypertensive encephalopathy or cerebrovascular accident, or
- •history within 12 months from visit 1 for transient ischemic attack (TIA),
- •myocardial infarction, coronary bypass surgery, or any percutaneous coronary
- •intervention (PCI).
- •7. Previous or current diagnosis of heart failure (NYHA Class III-IV).
- •8. Serum potassium > 5.3 mEq/L (mmol/L) at Visit 1.
- •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 antidiabetic
- •medication for at least 4 weeks prior Visit 1.
- •10. Current angina pectoris requiring pharmacological therapy except for nitrates.
研究者
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