EUCTR2006-000774-70-SE进行中（未招募）不适用
An 8-week, multicenter, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of the combination of valsartan/HCTZ/amlodipine compared to valsartan/HCTZ, valsartan/amlodipine, and HCTZ/amlodipine in patients with moderate to severe hypertension
适应症
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
- 2,252
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 patients = 18 years and < 86 years of age are eligible.
- •2.Systolic and diastolic blood pressure requirements:
- •Diagnosis of moderate to severe hypertension (MSDBP = 100 mmHg and < 120 mmHg, MSSBP = 145 mmHg and < 200 mmHg) at Visit 3
- •Patients must also meet the blood pressure requirements (MSDBP = 95 mmHg and < 110 mmHg, MSSBP < 180 mmHg) at Visit 2
- •MSDBP = 110 mmHg and < 120 mmHg, and MSSBP = 145 mmHg and < 200 mmHg, or MSDBP = 100 mmHg and < 110 mmHg and MSSBP = 180 mmHg and < 200 mmHg after one week of treatment with placebo (blood pressure check) or at any subsequent scheduled study visit or blood pressure evaluation during the single-blind run-in period (designated Visit 3)
- •3.Written informed consent to participate in the study prior to any study procedures.
- •4.Ability to communicate and comply with all study requirements.
- •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.Inability to discontinue all prior antihypertensive medications safely for a period of 1 to 5 weeks as required by the protocol.
- •2.Patients with an MSSBP = 180 mmHg and MSDBP < 100 mmHg at any time between one week (7 ± 3 days) and four weeks of treatment with placebo must be discontinued from the study.
- •3.Patients on two or more antihypertensive drugs with MSSBP = 180 mmHg and/or MSDBP = 110 mmHg at Visit 1 (see Table 4-2).
- •4.Patients on three or more antihypertensive drugs with MSDBP = 90 mmHg and < 110 mmHg, and/or MSSBP = 140 mmHg and < 180 mmHg at Visit 1(see Table 4-2).
- •5.Patients on four or more antihypertensive drugs at Visit 1 (see Table 4-2).
- •6.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).
- •7.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner, 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 bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, hysterectomy), double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
- •Hormonal contraceptive use is disallowed.
- •8.Known moderate or malignant retinopathy. Defined as: moderate (retinal signs of hemorrhage, microaneurysm, cotton-wool spot, hard exudates, or a combination thereof) or malignant (signs of moderate retinopathy plus swelling of the optic disk).
- •9.Any history of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack.
- •10.Any history of myocardial infarction or all types of revascularization procedures.
- •11.Heart failure requiring treatment.
- •12.Second or third degree heart block with or without a pacemaker.
- •13.Angina pectoris of any type.
- •14.Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
- •15.Clinically significant valvular heart disease.
- •16.Evidence of a secondary form of hypertension, including but not limited to any of the following: coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing disease, pheochromocytoma, polycystic kidney disease.
- •17.All patients with Type 1 diabetes mellitus and those patients with Type 2 diabetes mellitus who are not well controlled based on the Investigator’s clinical judgement. It is recommended that Type 2 diabetic patients are adequately controlled and, if treated with medication, be on a stable dose of oral anti-diabetic medication for at least 4 weeks prior to Visit 1.
- •18.Any condition, not identified in the protocol, that in the opinion of the Investigator or the Novartis monitor, places the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the trial period.
- •19.Administration of any agent indicated for the treatment of hypertension after Visit 1, with the permitted exception of those antihypertensive medications requirin
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