hypertension MedDRA version: 14.1 Level: PT Classification code 10020772 Term: Hypertension System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Product Name: Losartan Potassium
Product Code: MK-0954
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: Losartan Potassium
CAS Number: 124750-99-8
Current Sponsor code: MK-0954
Oth
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is male or female from 6 months to 6 years of age. (Patient has not reached 7th birthday at time of randomization). Patient age refers to chronological age not corrected age as in the prematurely born infant population 2. Patient is determined to be hypertensive according to one of the following criteria: Patient is 6 months to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient has a history of severe or symptomatic hypertension (e.g.hypertensioninduced seizures, stroke, encephalopathy) within 1 year of Visit 1 including patients whose SBP or DBP >99th percentile for gender/age/height plus 10 mm Hg. 2. Patient has a history of clinically significant heart failure, rhythm disturbance or cardiomyopathy, or hemodynamically significant obstructive valvular disease. 3. Patient has clinically significant neurologic, respiratory, gastrointestinal, hepatobiliary, or hematologic disease. 4. Patient has a known history of uncorrected coarctation of the aorta, bilateral renal artery stenosis, or renal artery stenosis to a single kidney. 5. Patient has a glomerular filtration rate of 2X the upper limit of normal Total bilirubin or direct bilirubin >2X the upper limit of normal White blood cell count <3000/mm3 Platelet count <100,000/mm3 Serum potassium =5.5 mEq/L (=5.0 mEq/L if concomitantly on ACE-inhibitor) Serum sodium =130 mEq/L 7. Patient has a known sensitivity to losartan or other ARB, or any history of angioneurotic edema. 8. Patient or patient’s guardian who, in the opinion of the investigator, will not fully cooperate, keep appointments, or who has been generally unreliable. 9. Patient has any other factors limiting participation (e.g., significant, concurrent, or life-threatening diseases such as cancer, or mental incapacitation). 10. Patient is currently being treated with any of the following: angiotensin II type I receptor blocker (ARB) cyclosporine or tacrolimus (FK-506) potassium-sparing diuretics (triamterene, amiloride, spironolactone and eplerenone) herbal supplements pentamidine trimethoprim lithium potassium supplements chronic analgesics (NSAIDS, opioids, acetaminophen, aspirin) 11. Patient has used any investigational compounds within 30 days of Visit 1. 12. Patient has started any new concomitant antihypertensive medications within 30 days of Visit 1. Dosage of concomitant antihypertensive medications should be stable for 30 days before Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Change in sitting systolic blood pressure (SBP) after 21 days of treatment (the end of the 1st dose period) compared to baseline as a function of dose;Timepoint(s) of evaluation of this end point: 21 days;Main Objective: (1) To define a dose-response relationship for losartan in hypertensive children aged 6 months to 6 years, after a 21-day open-label treatment period (response assessed by change from baseline in mean trough SBP). (2) To investigate the safety and tolerability of losartan at doses up to 1.4 mg/kg/day in hypertensive children aged 6 months to 6 years after 12 weeks of treatment. ;Secondary Objective: (1) To define a dose-response relationship for losartan in hypertensive children aged 6 months to 6 years, after a 21-day open-label treatment period (response as assessed by change from baseline in mean trough DBP). (2) To estimate the change from baseline in SBP in each dose regimen by Day 21. (3) To estimate the change from baseline in DBP in each dose regimen by Day 21. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoint is the slope of change in sitting diastolic blood pressure (DBP) after 21 days of treatment (the end of the first dose-period) as compared to baseline as a function of dose. Other secondary efficacy endpoints include the change from baseline in SBP and DBP by Day 21.;Timepoint(s) of evaluation of this end point: 21 days | — |
Countries
Argentina, Brazil, Chile, Colombia, European Union, Guatemala, Hungary, India, Lithuania, Philippines, Spain, United Kingdom, United States
Contacts
Public ContactDr. Steven Hildemann
MSD Regional Business Support Center GmbH
Outcome results
None listed