None listed
Conditions
Interventions
50 mg losartan for 6 weeks. If after 6 weeks of treatment the patients blood pressure has not been controlled, the patient will be titrated with a dose of 50 mg of losartan / 12.5 mg of HCTZ once a day for 6 more weeks. If after 12 weeks of treatment the patients blood pressure has not been controlled, the patient will be titrated with a dose of 100 mg losartan / 25 mg HCTZ once a day during the last six weeks of the study.
Group name:Group II Type of group
5 mg of amlodipine for 6 weeks. If after 6 weeks of treatment the patients blood pressure has not been controlled, the patient will be titrated with 10 mg of amlodipine once a day for 6 weeks. If after 12 weeks of treatment the patients blood pressure has not been controlled, the patient will be titrated with 10 mg of amlodipine plus 25 mg of HCTZ once a day during the last six weeks of the study.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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 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 ( 120%).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Measure:Efficacy Timepoints:At each clinical visit throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Adverse experiences will be monitored, which will be recorded, in each of the exams, in the Adverse Event Case Report Forms. Measure:Safety Timepoints:During the whole study. | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed