EUCTR2006-001311-30-DE进行中（未招募）不适用
An open-label, multicenter study to evaluate the efficacy and tolerability of a 4 week therapy with the fixed dose combination of valsartan 160 mg plus HCTZ 25 mg in hypertensive patients not adequately responding to a 4 week therapy with the free combination of an angiotensin receptor blocker (candersartan 32 mg) plus HCTZ 25 mg - CICERO
ovartis Pharma GmbH0 个研究点目标入组 220 人开始时间: 2006年4月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
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
- •For inclusion into the study, patients must meet all of the following inclusion criteria:
- •1.Male or female patients >= 18 years
- •2.Patients with essential hypertension:
- •-At Visit 1, untreated patients must have a MSDBP >= 100 mmHg and < 110 mmHg and treated patients need to have a MSDBP < 110 mmHg. Untreated patients can be included as soon as the safety laboratory parameters are available, but not at the day of Visit 1. This inclusion visit will be recorded as Visit 3 in the CRF.
- •-At Visit 2, patients previously treated for hypertension need to have a MSDBP >= 100 mmHg and < 110 mmHg for entrance into the first treatment phase. Patients previously treated for hypertension who have a MSDBP < 100 mmHg at Visit 2 will continue the wash-out phase and will be again evaluated with regard to BP criteria at Visit 3. Untreated patients do not perform Visit 2.
- •-At Visit 3, which is not performed for patients who entered the first treatment phase already at Visit 2, patients need to have a MSDBP >= 100 mmHg and < 110 mmHg for entrance into the first treatment phase.
- •-At Visit 4, all patients need to have a MSDBP >= 90 mmHg for entrance into the second treatment phase
- •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.Patients with controlled blood pressure levels (MSSBP < 140 mmHg and MSDBP < 90 mmHg) under current antihypertensive therapy at Visit 1.
- •2.MSDBP >= 110 mmHg or MSSBP >= 180 mmHg at any time between visit 1 and baseline
- •3.Inability to completely discontinue all antihypertensive medications safely for a period of up to 2 weeks, as required by the protocol
- •4.Known Keith-Wagener grade III or IV hypertensive retinopathy
- •5.Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral renal artery stenosis or pheochromocytoma
- •6.History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures, known or suspected contraindications to angiotensin II receptor blockers or to diuretics as described in the SmPC (particularly candesartan 16 - 32 mg, valsartan 160 mg, HCTZ 12.5 – 25 mg)
- •7.Heart failure NYHA II-IV
- •8.Second or third degree heart block without pacemaker
- •9.Concomitant refractory angina pectoris
- •10.Concomitant potentially life-threatening arrhythmia or symptomatic arrhythmia
- •11.Clinically significant valvular heart disease
- •12.Transient ischemic cerebral attack, stroke, hypertensive encephalopathy or myocardial infarction prior to Visit 1
- •13.Type 1 diabetes mellitus
- •14.Type 2 diabetes mellitus with poor glucose control as defined by persistent fasting blood glucose > 11 mmol/l or > 200 mg/dl at Visit 1.
- •15.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug including but not limited to any of the following:
- •?History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
- •?Currently active, or active inflammatory bowel syndrome within 12 months prior to Visit 1
- •?Currently active gastritis, ulcers or gastrointestinal/ rectal bleeding (hemorrhoids not included)
- •?Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/ injury
- •?Evidence of hepatic disease or cholestasis as determined by any one of the following: ALT or AST values > 2 x ULN at Visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of a portocaval shunt, obstruction of the biliary tract
- •?Evidence of renal impairment as determined by any one of the following: serum creatinine > 1.5 x ULN or active acute glomerulonephritis at Visit 1, a history of dialysis, or a history of nephrotic syndrome
- •?Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions which is likely to require intervention during the course of the study or is regarded as clinically meaningful by the investigator
- •16.Therapy resistant hypokalemia, hypercalcemia, symptomatic hyperuricemia or sodium depletion (< 134 mmol/l), patients with volume depletion.
- •17.History of any severe, life-threatening disease
- •18.History of drug or alcohol abuse within the last 2 years
- •19.History of non-compliance to medical regimens, or those patients unwilling to comply with the trial protocol.
- •22.Unwillingness or inability to give informed consent
- •23.Persons directly involved in the execution of this protocol
- •24.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- •25.History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of l
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