Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with hypertension in ages 12 months - 16 years
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Children less than 6 years old: oral suspension or tablets equal to 0.3 mg/kg; 20 mg or 40 mg tablets for older children depending on weight.
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
La Jolla, California, United States
Unnamed facility
Louisville, Kentucky, United States
Unnamed facility
Kansas City, Missouri, United States
Unnamed facility
For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)
Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, Area Under the Concentration-time Curve From the Time of the Dose to Infinity
Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Elimination Constant Rate
Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Maximum Plasma Concentration Over the Entire Sampling Phase
Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Foe Olmesartan, the Time of Maximum Plasma Concentration
Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Elimination Half-life of the Drug in Plasma
Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Apparent Oral Clearance
Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Apparent Oral Volume of Distribution
Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
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Cleveland, Ohio, United States