None listed
Conditions
Interventions
Low Dose Type of group
losartan 2.5 / 5 mg once a day for 21 days
Group name:High Dose Type of group
losartan 50/100 mg once a day for 21 days
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • Male and female patients, weighing> 20 kg, with ages between 6 and 12 years of age. Age will be defined according to the date on which the respective age is met (for example, a patient will be considered 9 years old from the date of his ninth birthday until the day before his tenth birthday). • Patients should have an average SIDBF greater than the 95th percentile based on sex, height and age at the end of the wash phase from days 2 to 7. Qualifying blood pressure will be determined by 2 groups of confirmatory pressure measurements arterial (performed three times) that will be taken at least 1 hour apart. • Patients should have an estimated glomerular filtration rate of> 30 ml / min / 1.73 m2, determined according to the Schwartz Formula, based on the serum creatinine of Day -7 • Patients should be able to swallow tablets. • The informed consent of the parents and the patient´s permission are required (when appropriate). • The general study will be balanced according to race, sex and age (through central monitoring in Merck). Approximately between 10 and 30% of the patients will be black (the race will be determined by the patient´s own statement), approximately 25-50% of the patients will be women, and at least 50% of the patients will be women. will be between 6 and 16 years of age (or Stage 3 of Tanner).
Exclusion criteria
Exclusion criteria: • History of severe or symptomatic hypertension (for example, seizures, stroke, encephalopathy induced by hypertension) within 1 year. Patients who require more than 2 antihypertensive medications to control their blood pressure. • History of heart failure, hemodynamically significant obstructive valvular disease or cardiomyopathy. • Clinically significant neurological, respiratory, gastrointestinal, hepatobiliary or hematologic disease. • Known history of uncorrected coarctation of the aorta, bilateral stenosis of the renal artery or unilateral renal artery stenosis of a single kidney. Severely nephrotic patients who are not in remission should be excluded. • Patients who have undergone major organ transplantation (for example, heart, kidney, liver). • Clinically significant laboratory values ​​outside the established normal range, including but not limited to, any of the following parameters: SGOT (AST) or SGPT (ALT)> 2 times the normal maximum limit, total billrubin or direct birrubin> 2 times the normal maximum limit, white blood cell count 5.5 mEq / L, serum sodium <1 30 mEq / L • Alteration in clinically significant AV conduction (for example, second or third degree AV block or left bundle branch block), sinus disease syndrome, clinically significant bradycardia, flutter or atrial fibrillation, and an accessory bypass (bypass) ( for example, Stokes-Adams Syndrome or Wolff-Parkinson-White Syndrome). • Pregnant or lactating women. Pregnancy tests will be carried out on all women throughout the study. During the study, patients whose tests tested positive must be removed and Merck Research Laboratories (MRL) must be notified. Patients of childbearing age should receive advice regarding the need to use effective methods for birth control. • Known sensitivity to angiotensin II antagonists or any history of angioneurotic edema. • Patients, who, in the opinion of the researcher, will not cooperate fully, will not attend their appointments or who, in general, are not reliable. • Other factors that may affect your participation (for example, significant, concurrent or life-threatening illnesses such as cancer, mental disability or research drug use within 4 weeks prior to enrollment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The primary efficacy measure of this study will be the change in SiDBP. Measure:Efficacy Timepoints:From the Basal Phase to Day 22. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Adverse events will be recorded in each exam in the Adverse Event Case Report Forms. Measure:Safety Timepoints:During the study | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed