EUCTR2006-005556-32-DK进行中（未招募）不适用
Phase III Study Evaluating the Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide 40/12.5 mg Combination Therapy versus Olmesartan Medoxomil 40 mg Monotherapy in Patients with Essential Hypertension
Menarini Ricerche S.p.A.0 个研究点目标入组 1,400 人开始时间: 2007年4月16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
- 1,400
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 Caucasian patients = 18 years of age. A female of childbearing potential may be enrolled providing she:
- •- has a negative pregnancy test at screening/enrolment and
- •randomisation, and
- •- is routinely using a highly effective method of birth control resulting
- •in a low failure rate (i.e. less than 1% per year) when used
- •consistently and correctly, e.g. implants, injectables, combined oral
- •contraceptives, hormone containing intra uterine devices (IUDs).
- •2. Patients with a diagnosis of essential hypertension, either treatment-naive
- •or currently on anti-hypertensive medication in whom it is medically
- •justifiable to withdraw treatment, and who are likely to meet the required
- •BP inclusion criteria at randomisation (see inclusion criteria No. 3
- •3. BP criteria at randomisation:
- •a) Mean sitting dBP = 100 mmHg and = 120 mmHg.
- •b) Mean sitting sBP = 160 mmHg and = 200 mmHg.
- •4. Patients who have freely given 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
- •1. Patients with mean sitting sBP values > 200 mmHg and/or dBP
- •> 120 mmHg.
- •2. Pregnant or nursing women.
- •3. Patients with serious disorders which may limit the ability to evaluate the
- •efficacy or safety of the tested medication, including cerebrovascular,
- •cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or
- •metabolic, haematological, oncological, neurological, and psychiatric
- •diseases. The same applies for immunocompromised and/or neutropenic
- •4. Patients having a history of the following within the last six months:
- •Myocardial infarction, unstable angina pectoris, percutaneous coronary
- •intervention, hypertensive encephalopathy, cerebrovascular accident
- •(stroke), or transient ischaemic attack.
- •5. Patients with clinically relevant significant abnormal laboratory values at
- •screening/enrolment, including patients with:
- •- aspartate aminotransferase/serum glutamic-oxaloacetic-transaminase
- •(ASAT/SGOT) and alanine aminotransferase/serum glutamic –
- •pyruvate - transaminase (ALAT/SGPT) greater than twice the upper
- •limit and/or gamma-glutamyltransferase (?-GT) greater than three times
- •the upper limit of laboratory reference range
- •- potassium above the upper limit of laboratory reference range (unless
- •high value is due to haemolytic blood sample).
- •6. Patients with secondary hypertension of any aetiology such as renal
- •disease, pheochromocytoma, or Cushing’s syndrome.
- •7. Patients with contraindication to Hydrochlorothiazide (HCTZ) and/or
- •8. Patients with electrocardiographic evidence of 2nd or 3rd degree
- •atrioventricular (AV)-block, atrial fibrillation or other cardiac arrhythmia
- •(requiring treatment), or bradycardia (< 50 beats/min as measured by
- •mean radial heart rate).
- •9. Patients with severe heart failure (New York Heart Association stage IIIIV),
- •a narrowing of the aortic or bicuspid valve, an obstruction of cardiac
- •outflow (obstructive, hypertrophic cardiomyopathy) or symptomatic
- •coronary disease.
- •10. Patients with clinical evidence of a renal disease (including renovascular
- •occlusive disease, nephrectomy and/or renal transplant, bilateral renal
- •artery stenosis or unilateral renal artery stenosis in a solitary kidney, or
- •severe renal impairment as evidenced by creatinine clearance (CLCR) < 30
- •11. Patients with uncorrected coarctation of aorta and higher grades of
- •acquired aortic stenosis.
- •12. Patients with clinically relevant hepatic impairment.
- •13. Patients with biliary obstruction.
- •14. Poorly controlled diabetic patients, defined as Type 1 or Type 2 patients
- •with a fasting glucose >12.21 mmol/L [>220 mg/dL].
- •15. Patients with a history of a wasting disease (e.g. cancer), autoimmune
- •diseases, connective tissue diseases, major allergies, or angioneurotic
- •16. Patients being treated for other diseases with drugs or medication which
- •may influence BP or interfere with the objectives of the study and which
- •cannot be withdrawn during the period of the study (e.g. alpha-blockers
- •for the treatment of benign prostatic hypertrophy or intra-ocular betablockers
- •for the treatment of glaucoma).
- •17. Patients being treated at randomisation with any antihypertensive
- 另有 6 项未显示
研究者
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