PER-008-14未知未知
A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVECONTROLLEDSTUDY TO COMPARE THE SYSTOLIC BLOOD PRESSURELOWERING EFFICACY OF ALISKIREN, RAMIPRIL AND A COMBINATION OFALISKIREN AND AMLODIPINE, WITH AN INITIAL 8-WEEK EVALUATION,FOLLOWED BY A 2-3 YEAR FOLLOW-UP TO COMPARE LONG-TERMSAFETY OF AN ALISKIREN-BASED REGIMEN TO A RAMIPRIL-BASEDREGIMEN IN HYPERTENSIVE PATIENTS ≥ 65 YEARS OF AGE
OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2014年5月29日最近更新:
适应症
试验速览
- 阶段
- 未知
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 65 至 100（—）
- 性别
- All
入选标准
- •Male or female patients ≥ 65 years of age with a clinical diagnosis of essential hypertension at
- •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 (i.e., Visit
- •2 or Visit 201)
排除标准
- •History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- •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.
- •Current treatment with any blocker of the renin angiotensin aldosterone system (RAAS) (aliskiren,
- •ACE inhibitor, angiotensin receptor blocker or an aldosterone antagonist) and unable to
- •discontinue this therapy.
- •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), beta blockers for angina, or beta blocker ophthalmic preparations.
- •Contraindications to aliskiren, ramipril, amlodipine, or hydrochlorothiazide.
- •Investigational and reference therapy:
- •Aliskiren monotherapy low-dose (aliskiren 150 mg)
- •Aliskiren monotherapy high-dose (aliskiren 300 mg)
- •Aliskiren dual therapy low-dose (aliskiren 150 mg + amlodipine 5 mg)
- •Aliskiren dual therapy high-dose (aliskiren 300 mg + amlodipine 5 mg)
- •Ramipril monotherapy low-dose (ramipril 5 mg)
- •Ramipril monotherapy high-dose (ramipril 10 mg)
- •Optional addition/up-titration of amlodipine (5 mg/10 mg) and hydrochlorothiazide (12.5 mg/25 mg) will
- •be based on systolic blood pressure control.
- •Efficacy assessments:
- •Mean sitting systolic blood pressure (MSSBP)
- •Blood pressure control (MSSBP/MSDBP < 140/90 mmHg)
- •Other assessments:
- •Physical examination
- •Vital signs
- •Height, weight and waist circumference
- •Laboratory evaluations
- •Electrocardiogram (ECG)
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