EUCTR2006-006350-10-DE进行中（未招募）不适用
DOUBLE BLIND, RANDOMISED, PARALLEL GROUP, MULTICENTRE STUDY TO EVALUATE THE EFFECTS OF MANIDIPINE 20 MG VS AMLODIPINE 10 MG AND THE COMBINATION OF MANIDIPINE 10 MG PLUS DELAPRIL 30 MG VS AMLODIPINE 5 MG PLUS DELAPRIL 30 MG ON INTRAGLOMERULAR PRESSURE IN HYPERTENSIVE PATIENTS. - MANTRA
Chiesi Farmaceutici0 个研究点目标入组 100 人开始时间: 2007年12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
- •To be eligible for study entry all patients must satisfy the following criteria at the time points specified:
- •Visit 1 (Day -28/-14):
- •1.Male or female aged >= 18 years <= 65 years (females of child bearing potential must be using adequate contraceptive precautions, i.e. hormonal contraceptives, IUP and sterilisation)
- •2.Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at enrolment visit
- •3.Patients with mild to moderate uncomplicated essential hypertension with a trough mean sitting DBP >90? and <110 mmHg and SBP <180 mmHg
- •4.No evidence of significant cardiovascular disease other than hypertension in the opinion of the Investigator
- •5.Written informed consent obtained
- •6.Agreement to attend all study visits as planned in the protocol
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.In the Investigator’s opinion the patient should not be withdrawn from their current antihypertensive medication
- •2.Malignant or secondary hypertension (e.g. patients with hyperaldosteronism, pheochromocytoma, renal artery stenosis, renal parenchymal disease, coarctation of the aorta, Cushing’s disease syndrome)
- •3.History of severe elevated blood pressure (mean sitting DBP >110 mmHg and/or SBP >180 mmHg).
- •4.Obesity as defined by a Body Mass Index (BMI) > 35 kg/m2
- •5.Hypertensive retinopathy (Keith Wagener Barker [KWB] scale) grade 3 or 4
- •6.History of hypertensive encephalopathy or cerebrovascular accident
- •7.Presence of cardiac disease especially aortic stenosis II° and III° other than: uncomplicated hypertensive cardiovascular disease or a single uncomplicated myocardial infarction (MI), which occurred a minimum of twelve months before this study with stable ECG findings for a minimum of twelve months before this study
- •8.History of MI complicated by congestive heart failure or post-MI angina
- •9.Presence of significant pulmonary, hepatic, renal, endocrine, metabolic or haematological disease, disorder or dysfunction
- •10.Laboratory evidence of significant disease including the following:
- •11.Serum creatinine >1.5 mg/dl
- •12.Serum potassium >10% x upper limit of normal (ULN)
- •13.Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3 x ULN and/or total serum bilirubin >2 x ULN
- •14.Presence of gastrointestinal disease or history of gastrointestinal surgery which would interfere with drug absorption
- •15.History of significant allergies (including multiple drug allergies)
- •16.History of cancer including leukaemia and lymphoma within the past five years (skin cancer, other than melanoma, is an exception)
- •17.Diabetes mellitus requiring treatment with insulin
- •18.Uncontrolled diabetes (HbA1c > 7.5%)
- •19.Chronic use of any drug known to affect blood pressure such as: tricyclic antidepressants, monoamine oxidase inhibitors, neuroleptic drugs (any type), centrally acting antihypertensives (e.g. clonidine, methyldopa, guanfacin, moxonidine), reserpin, non-steroidal anti-inflammatory drug (NSAID) (acetylsalicylic acid [ASA] ?0.5 gram/day is allowed), oral or parenteral corticosteroids, antiarrhythmic drugs, digitalis and cardiac glycosides, amphetamine and its derivatives
- •20.Concomitant treatment with other antihypertensive drugs different from the study drugs (i.e. alpha receptor blockers and agonists, beta receptor blockers and agonists, calcium antagonists ACE inhibitors, angiotensin–II receptor antagonist and diuretics)
- •21.Chronic nitrate treatment, e.g. isosorbide dinitrate or isosorbide mononitrate (short acting nitrates are permitted except just before blood pressure assessments)
- •22.Concomitiant use of CYP3A4-inhibitors like antiproteinases, cimetidine, ketoconazol, itraconazol, erythromycine, clarithromycine, and concomitant use of CYP3A4-activators like phenytoin, carbamazepine, phenonarbital, rifamicipine.
- •23.Concomitant use of lithium salts
- •24.Known allergy or a known intolerance to any calcium-antagonist or ACE-inhibitors or ARB
- •25.Females who are pregnant or lactating
- •26.Use of any investigational drug within 28 days before study entry
- •27.Patients previously enrolled into the study
- •28.History of drug, medications abuse.
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