None listed
Conditions
Interventions
1 month to 25 to 45 kg.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • Male or female patients from 1 month to 30 mL / min / 1.73m ^, as determined by the Schwartz Formula based on baseline serum creatinine: • The informed consent of the parents is required. The patient´s approval will be obtained (when feasible) if required.
Exclusion criteria
Exclusion criteria: • History of severe or symptomatic hypertension (for example: seizures induced by hypertension, cerebrovascular accident, encephalopathy) within 1 year. Patient who requires more than 2 antihypertensive medications to control blood pressure. • History of heart failure, hemodynamically significant obstructive valve disease or cardiomyopathy. • Clinically significant neurological, respiratory, gastrointestinal, hepatobiliary or hematologic disease. • Known antecedents of uncorrected coarctation of the aorta, bilateral stenosis of the renal artery or unilateral stenosis of the renal artery in patients with only one kidney. Patients with severe nephrotic syndrome who are not in remission should be excluded. • Patients who have undergone major organ transplantation (for example: heart, kidney, liver). • Clinically significant laboratory values ​​that are outside the normal range established • Clinically significant disturbance of atrioventricular conduction (for example: atrio-ventricular block in second or third degree or left bundle branch block), sinus node syndrome, clinically significant bradycardia, atrial flutter or atrial fibrillation and an accessory conduction tract ( for example: Stokes-Adams Syndrome or Wolff-Parkinson-White Syndrome). • Patients can not receive lisinopril or enalapril for 2 weeks before the first dose of the study drug. The use of captopril before the study is allowed. Also, the use of other antihypertensive medications (excluding ACE inhibitors and angiotensin II receptor antagonists) is permitted before the study and in Days 2 to 6 of the study. • Known sensitivity to ACE inhibitors or a history of angioneurotic edema. • Patients, who in the opinion of the researcher, will not cooperate fully, will not attend appointments or, in general, have not been reliable. • Other factors that may have affected the subject´s participation (for example: important, concurrent or life-threatening diseases such as cancer, mental disability or the use of investigational drugs for 4 weeks before enrollment). • Pregnant or breastfeeding women (pregnancy tests should be performed on all women who are 6 years old or older before and during the study). Women of childbearing age can participate as long as they accept to use adequate methods of contraception and do not get pregnant during the duration of the study. If a patient becomes pregnant, she will be immediately removed from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Blood pressure measurement Measure:Blood pressure measurement Timepoints:Days 1 and 7 comparing it with the baseline. ; Outcome name:The pharmacokinetic parameters will include programmed blood sampling at steady state for the measurement of serum lisinopril in order to evaluate the ADC (0-24 hours) Cmax and Tmax in children. Urine shots will also be scheduled to evaluate the recovery of lisinopril in urine. Measure:Pharmacokinetics Timepoints:After 7 days of treatment | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed