Study of Losartan Potassium in Pediatric Patients With Hypertensio

• Conditions: hypertension; MedDRA version: 14.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2008-004732-20-Outside-EU/EEA
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-30
• Last Update Posted: 18 September 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 100

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 <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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 <30 ml/min/1.73m2 as determined by the
Schwartz Formula, based on the baseline serum creatinine:

GFR = 0.55 x height (cm)/Serum creatinine (mg/dL)

[Note: For patients <1 year of age, the constant 0.45 will be used in place of 0.55.
For patients <1 year of age who were born with low birth weight (regardless of
gestational age), the constant 0.33 will be used in place of 0.55.]

Low birth weight is defined as <2500 grams (2.5 kilograms).

The constant that is used for an individual patient at the start of the study will be used for that patient for the duration of the base study. During the extension phase, the constant appropriate for the child’s chronological age will be used.

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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified