EUCTR2009-011776-30-DE进行中（未招募）不适用
Clinical Study to Evaluate the Efficacy and Safety of the Combination Therapy Candesartan Cilexetil 32 mg plus Hydrochlorothiazide 25 mg in Patients with Severe Hypertension
Takeda Pharma GmbH0 个研究点目标入组 100 人开始时间: 2009年7月13日最近更新:
适应症
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
- 100
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
- •Main Criteria for Inclusion:
- •Subjects with severe essential hypertension (SBP between 150 mmHg and 200 mmHg AND DBP between 110 mmHg and 120 mmHg) who did not receive any antihypertensive treatment before and who gave informed consent will be included in the study. In females a negative pregnancy test and willingness to apply two independent methods of contraception will be additionally required.
- •Patients will be included in the study if they met all of the following inclusion criteria:
- •1. Male and female outpatients of at least 18 years of age with a confirmed diagnosis of essential hypertension.
- •2.SBP between 150 mmHg and 200 mmHg AND DBP between 110 mmHg and 120 mmHg. Blood pressure will be measured in sitting position.
- •3. Patients did not receive any antihypertensive treatment so far.
- •4. Negative pregnancy test at baseline (visit 1) in females of childbearing potential. Male or female patients with reproductive potential must use an approved contraceptive method during study treatment evaluation (for details see Section 7.7)
- •5. 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
- •Main Criteria for Exclusion:
- •Subjects will not be included if they suffer from secondary hypertension, if they suffer from a severe concomitant disease, if they provide a contraindication for Candesartan cilexetil or Hydrochlorothiazide or if they are not eligible for other reasons (e.g., intake of psychotropic medication, addiction to alcohol or drugs, pregnancy, known or suspected non-compliance).
- •Patients will be excluded from the study if they met any of the following exclusion criteria:
- •1.Known or suspected secondary hypertension or primary hyperaldosteronism.
- •2.Impaired renal function (creatinine concentration in serum =180 µmol/l for men respectively =140 µmol/l for women).
- •3.Severe hepatic impairment: ALAT and/or ASAT and/or ?-GT >3 x ULN and/or cholestasis.
- •4.Bilateral renal artery stenosis, solitary kidney or post-renal transplant status.
- •5.History of myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention or cerebral accident (stroke or transient ischaemic attack) within the last 6 months.
- •6.Diagnosis or suspicion of the following conditions: hypertrophic obstructive cardiomyopathy, angina pectoris, chronic heart failure, peripheral arterial occlusive disease, hypertensive retinopathy.
- •7.Haemodynamically relevant stenosis of the aortic or mitral valve.
- •8.Clinically relevant and refractory hypo- (<3.5 mval/l) or hyperkalaemia (>5.5 mval/l).
- •9.Uncorrected volume or sodium depletion.
- •10.Gout or relevant hyperuricaemia.
- •11.Known intolerance/hypersensitivity to Candesartan cilexetil or Hydrochlorothiazide.
- •12.Known galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
- •13.Patients taking psychotropic medication or being addicted to alcohol or drugs.
- •14.Pregnant or breast feeding women.
- •15.Known or suspected inability or unwillingness to abide by the requirements of the study protocol.
- •16.Known or suspected non-compliance regarding intake of the study medication.
- •17.Subject has participated in another trial of an investigational drug or a medical device within the last 30 days or is currently participating in another trial of an investigational drug or a medical device.
- •18.Personnel involved in the planning or conduct of the study
- •19.Withdrawal of informed consent.
研究者
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