A Phase III, Randomized, Open-Label, Parallel-Group, Dose-Ranging Clinical Trial to Study the Safety and Efficacy of MK-0954/Losartan Potassium in Pediatric Patients With Hypertensio
- Conditions
- Health Condition 1: null- Pediatric Hypertension
- Registration Number
- CTRI/2009/091/000045
- Lead Sponsor
- Merck Sharp Dohme Corp a subsidiary of Merck Co Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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 <1 year old with a mean systolic blood pressure >= 95th
percentile based on gender and age.
OR
Patient is >=1 year old with a mean systolic and/or diastolic blood pressure >= 95th
percentile based on gender, height and age.
OR
Patient has co-morbidities or evidence of end organ damage with:
a. mean systolic blood pressure >= 90th percentile (6 month to <1 year old) based on
gender and age.
OR
b. mean systolic and/or diastolic blood pressure >= 90th percentile (>=1 year old)
based on gender, height, and age. 3) Informed parental consent has been obtained. Patient assent (when feasible) has been
obtained as required by local regulations.
. 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 30 ml/min/1.73m2 as determined by the
Schwartz Formula, based on the baseline serum creatinine: 6. Patient has clinically significant laboratory values (as determined by the investigator)
at Visit 1 outside of the established normal range including but not limited to any of
the following parameters:
SGOT (AST) or SGPT (ALT) 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 patientâ??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). Exclusion Criteria Based on Concomitant Therapy
10. Patient is currently being treated with any of the following:
angiotensin II type I receptor blocker (ARB)
cyclosporine or tacrolimus (FK-506).
o Investigators may enter patients receiving other immunosuppressants provided
that the dose has been stable for at least 2 months prior to Visit 1. Patients
receiving systemic corticosteroids may be entered at the investigatorâ??s
discretion, provided that the dose has been stable for at least 2 months prior to
Visit 1.
potassium-s
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the safety and tolerability of losartan in hypersensitive children ages 6 months to 6 yearsTimepoint: After 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method To define a dose-response relationship for losartan in hypersensitive children ages 6 months to 6 yearsTimepoint: After 21 day treatment period