EUCTR2013-001562-42-HU进行中（未招募）不适用
A randomized, double-blind, parallel group, active-controlled study to compare the systolic blood pressure lowering efficacy of aliskiren, ramipril and a combination of aliskiren and amlodipine, with an initial 8-week evaluation, followed by a 2-3 year follow-up to compare long-term safety of an aliskiren-based regimen to a ramipril-based regimen in hypertensive patients = 65 years of age.
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
- 1,392
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
- •Inclusion Criteria: -Patients = 65 years of age with a clinical diagnosis of essential
- •hypertension at Visit 1.
- •-Mean sitting SBP (MSSBP) = 140 mmHg and < 180 mmHg at Visit 2/Visit 201 and Visit 3. –Absolute MSSBP difference = 20 mmHg between Visit 3 and the Visit immediately prior
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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 1392
排除标准
- •1.History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- •2.Severe hypertension (MSSBP = 180 mmHg or MSDBP = 110 mmHg) at Visit 1, Visit 2, Visit 201 or Visit 3 or during patient self measured blood pressure (SMBP) monitoring in the pre-randomization period confirmed by office measurement.
- •3.Current treatment with any blocker of the RAAS (aliskiren, ACEI, ARB or an aldosterone antagonist) and unable to discontinue this therapy.
- •4.Concurrent use of any anti-hypertensive medications except a stable dose of 3 months prior to Visit 1 of alpha adrenergic blockers for benign prostatic hypertrophy (e.g., tamsulosin [Flomax®] for benign prostatic hypertrophy [BPH]), beta blockers for angina, or beta blocker ophthalmic preparations.
- •5.Contraindications to aliskiren, ramipril, amlodipine, or HCTZ.
- •6.History of renal artery stenosis.
- •7.Known retinopathy.
- •8.History of hypertensive encephalopathy.
- •9.Known ejection fraction = 40%.
- •10.Current diagnosis of heart failure (NYHA Class III-IV).
- •11.History of transient ischemic cerebral attack (TIA) or cerebrovascular accident (CVA) within 6 months.
- •12.History of myocardial infarction, bypass surgery (CABG), or any percutaneous coronary intervention (PCI) within 6 months.
- •13.History of acute gouty arthritis within the last 3 years.
- •14.Serum sodium less than the lower limit of normal (minus 10 percent) or dehydration at Visit 1.
- •15.Serum potassium less than 3.5 mEq/L (corresponding to 3.5 mmol/L), or more than 5.2 mEq/L (corresponding to 5.2 mmol/L) at Visit 1.
- •16.Current unstable angina pectoris. Patients on a stable dose of oral or topical nitrates for angina are acceptable.
- •17.Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
- •18.Clinically significant valvular heart disease.
- •19.Evidence of renal impairment: eGFR < 60 ml/min/1.73m2 as estimated by the Modification of Diet in Renal Disease (MDRD) or the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equations using serum creatinine measured by an Isotope Dilution Mass Spectrometry (IDMS)-traceable creatinine assay at Visit 1.
- •20.Evidence of nephrotic range proteinuria as indicated by proteinuria > 3500 mg/day per 1.73m2 body surface area or nephrotic syndrome.
- •21.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.
- •22.Unstable type 2 diabetes mellitus (stable diabetes mellitus is defined as diabetes in patients on a stable regimen of diet and, if required, a stable dose of oral anti-diabetics and/or insulin during the last 3 month).
- •23.Concurrent treatment with cyclosporine, quinidine or systemic use of conazoles (e.g. itraconazole), except ketoconazole and voriconazole.
- •24.Any condition that in the opinion of the investigator or the Novartis Medical Monitor would confound the evaluation and interpretation of efficacy and/or safety data.
- •25.History of inflammatory bowel disease of the colon and small intestine (Crohn’s disease and ulcerative colitis).
- •26.History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- •27.History of chronic liver disease or abnormal ALT/SGPT (> 3 times the upper limit of the reference range) or total bilirubin (> 2 times the upper limit of the reference
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