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.
- Conditions
- I10-I10 Essential (primary) hypertensionEssential (primary) hypertension
- Registration Number
- PER-040-00
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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
• 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%).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Blood pressure measurement with a standard mercury sphygmomanometer. The measurement of routine blood pressure is a measurement in the valley; that is, the measurements taken 24 (between 22 and 26 hours) after the last dose in the morning.<br>Measure:Efficacy<br>Timepoints:At each clinical visit throughout the study.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Adverse experiences will be monitored, which will be recorded, in each of the exams, in the Adverse Event Case Report Forms.<br>Measure:Safety<br>Timepoints:During the whole study.<br>