PER-040-00已完成未知
Parallel Two-Arm, Triple-Blind, Randomized Study, whose purpose is to evaluate the efficacy, tolerability and safety of the Dosage of 50 mg of Losartan titled at 50 mg of Losartan / 12.5 mg of Hydrochlorothiazide, titrated to 100 mg of Losartan / 25 mg of Hydrochlorothiazide versus the dose of 5 mg of Amlodipine titrated to 10 mg of Amlodipine, titrated to 10 mg of Amlodipine plus 25 mg of Hydrochlorothiazide in patients suffering from Isolated Systolic Hypertension.
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2000年7月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 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
- 0 至 0（—）
入选标准
- •History of HSA before entering the period of placebo treatment. At visit 3, patients should have a mean systolic blood pressure in the sitting position of 160-200 mmHg, and an average diastolic blood pressure in the sitting position of> 65 and> 90 mmHg.
- •The difference between the average PASSe at visit 2 and the average PASSe at visit 3 should be within 15 mmHg.
- •The patient is old enough to provide consent at the time of entering the period of placebo treatment.
- •Desire to participate in this study as judged by the informed consent provided by the patient
排除标准
- •Secondary hypertension of some etiology, such as renal artery stenosis, coarctation of the aorta or pheochromocytoma.
- •History of malignant hypertension.
- •Operation of a single kidney.
- •Known sensitivity or intolerance to an angiotensin II receptor antagonist, calcium channel blockers or diuretics.
- •History of angioedema.
- •Known syncopal disorder.
- •Pregnant women or women of childbearing age who are sexually active and who do not use an adequate method of birth control (oral or double-barrier contraceptives).
- •Unstable diabetes mellitus.
- •Concomitant therapy with antihypertensive medications, including those used for other indications in addition to hypertension
- •Concomitant therapy with lithium and other psychotropic agents such as phenothiazines.
- •Concomitant therapy with oral steroids or ACTH.
- •Concomitant therapy with daily use NSAIDs, COX-II inhibitor or high doses of aspirin.
- •Concomitant therapy with cold and / or flu medications containing ephedrine.
- •Hypertension induced by oral contraceptives.
- •History of angina pectoris.
- •Symptomatic cerebrovascular disorder that includes transient ischemic attack (TIA). Myocardial infarction, percutaneous coronary intervention, coronary artery bypass and congestive heart failure within 6 months prior to randomization.
- •History of stroke.
- •Interference in clinically significant atrioventricular conduction (AV), for example, second or third degree AV block, sick sinus syndrome or clinically significant bradycardia (resting heart rate <45 beats / minute) without a permanent pacemaker.
- •Presence of atrial flutter and atrial fibrillation.
- •Ventricular arrhythmias that potentially threaten life, decompensated valvular disorder, presence of hemodynamically significant obstructive valvular disorder or cardiomyopathy.
- •Serum potassium of <3.5 or> 5.5. mEq / L.
- •Presence of severe hepatic dysfunction as manifested by AST (SGOT) twice higher than the upper limit of normal or ALT (SGPT) twice the upper limit of normal.
- •Hematuria> 20 RBC / hpf or of unknown etiology.
- •Prior to patient admission, hematuria should be assessed, etiology established and documented, and adequate treatment provided.
- •Clinically significant laboratory values that, in the investigator´s judgment, may be clinically significant for the outcome of this study. This includes, without limitation, platelet count, hemoglobin or hematocrit.
- •A moderate to severe renal dysfunction, as shown by a serum creatinine greater than 1.5 mg / dL and a creatinine clearance less than 40 cc / min
- •A history of clinically important gastrointestinal resection, malabsorption or cirrhosis of the liver.
- •Any concurrent severe disease that in the opinion of the investigator could rule out participation or survival.
- •Use of any drug in research or participation in any drug study during or within 30 days prior to the baseline.
- •Inability to be withdrawn from an antihypertensive medication and treated with placebo for a period of up to 4 weeks.
- •Inability or lack of desire to give consent or follow protocol procedures.
- •Circumference of the arm greater than 41 cm.
- •Failure to meet the requirements at the end of the placebo treatment period (<80% or> 120%).
研究者
相似试验
已完成
不适用
Bioequivalence study with clinical endpoint of generic diclofenac gel withVoltaren® gel in patients with osteoarthritis of knee.CTRI/2017/04/008304Mylan Laboratories Pvt Ltd1,220
招募中
不适用
Dentin hypersensitivity:A randomised clinical trial on the efficacy of 5% Fluorocalcium phosphosilicate containing novel bioactive glass dentifrice.CTRI/2018/05/014136SDM College of Dental Sciences and Hospital
尚未招募
不适用
A comparative study to know the effect of diclofenac gel (used for pain relief) with diclofenac tablet (used for pain relief) in for breast pain.CTRI/2019/02/017635All India Institute of Medical Sciences Bhubaneswar
进行中（未招募）
Unknown
A clinical study to check the safety and effectiveness of test treatments in adult human subjects having anemia or iron-deficiency anemiaCTRI/2023/10/059283ORGENETICS INC
进行中（未招募）
1 期
Parallel group, blinded, multi-centre study of mifepristone in patients with endometriosisendometriosis in reproductive-ageMedDRA version: 20.0 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604 - Reproductive system and breast disordersEUCTR2018-002367-26-HUitaphar Laboratorios490