EUCTR2005-000684-26-FI进行中（未招募）不适用
A randomized, double blind, parallel group, active-controlled, multi-center, 14 week study to evaluate the effectiveness of a valsartan versus an amlodipine treatment strategy in achieving blood pressure control in patients with stage 1 or stage 2 hypertension or uncontrolled on present monotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,244
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. Male or female outpatients, age between 18- 75 years of age, inclusive, at Visit 1
- •2. Stage/grade 1 or stage/grade 2 hypertension, MSSBP = 140 mm Hg, and/or MSDBP = 90 mm Hg, (based on the JNC-VII/ESC/ESH guidelines), at Visit 1 and 2 in untreated patients Untreated is defined as treatment naïve or patients not treated in the past 12 weeks.
- •Patients who are currently treated on monotherapy and uncontrolled (i.e. MSSBP =
- •140 mm Hg, and/or MSDBP = 90) and have a blood pressure = 160/100 mmHg at Visit 1 and Visit 2. Treatment is defined as having taken medication for a minimum of 4 weeks and until = 2 days prior to Visit 1.
- •Patients who neither meet the definition of treated or untreated will not be eligible for study entry.
- •3. Written informed consent to participate in the study prior to any study procedures
- •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. Current treatment with a CCB
- •2. MSSBP = 180 mm Hg or MSDBP = 110 mm Hg at any time between Visit 1 and Visit 2
- •3. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- •4. Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, renal artery stenosis, or pheochromocytoma, etc.
- •5. Cerebrovascular accident or myocardial infarction during the last 12 months, prior to Visit 1
- •6. Transient ischemic cerebral attack during the last 6 months, prior to Visit 1
- •7. History of/or symptoms consistent with congestive heart failure
- •8. Clinically significant valvular heart disease
- •9. Second or third degree heart block without a pacemaker
- •10. Concomitant angina pectoris
- •11. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia
- •12. Diabetes mellitus
- •13. Serum potassium < 3.5 or > 5.5 mmol/L without medication at Visit 1
- •14. Serum creatinine > 1.5 ULN at Visit 1 or a history of dialysis or nephrotic syndrome
- •15. ALT or AST values > 2 x ULN at Visit 1 or a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
- •16. 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) at Visit 1
- •17. 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: surgical sterilization (e.g., bilateral tubal ligation, hysterectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap).
- •18. Any surgical or medical condition which might alter the absorption, distribution,
- •metabolism, or excretion of any drug
- •19. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
- •20. History of any severe or life- threatening disease
- •21. History of drug or alcohol abuse within the last two years
- •22. History of noncompliance to medical regimens, or patients unwilling to comply with the study protocol
- •23. Any condition in the investigators opinion, which renders the patient unable to complete the study or which would produce significant risk to the patient
- •24. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer
- •25. Persons directly involved with the conduct of this study
- •26. Inability to communicate and comply with all study requirements
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