Olmesartan Pediatric Pharmacokinetic (PK) Study

Study Overview
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Brief Summary
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Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with hypertension in ages 12 months - 16 years

Official Title
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An Open-label Study of the Single-dose Pharmacokinetics of Olmesartan Medoxomil in Pediatric Patients With Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Olmesartan medoxomil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 12 months to 16 years inclusive Signed parental/guardian informed consent and assent from the subject Current treatment for hypertension, or, if not currently treated for hypertension, systolic blood pressure (SBP) greater than or equal to 95th percentile for gender and height-for-age, or, if not currently treated for hypertension, systolic blood pressure or diastolic blood pressure greater than or equal to 90th percentile for gender and height-for-age and diabetic or having a family history of hypertension Glomerular filtration rate (GFR) greater than or equal to 30 mL/min/1.73 m2, estimated using the Schwartz equation Sexually active females of child-bearing potential must be practicing an acceptable method of birth control Negative serum beta-human chorionic gonadotropin at screening and at admission (female of child-bearing potential only) Exclusion Criteria: Clinically significant cardiac, gastrointestinal, hematologic, hepatic or hepatobiliary, neurologic, or pulmonary (except asthma) disorder History of severe or symptomatic hypertension associated with stroke, seizures, encephalopathy, or other significant neurologic findings within 1 year prior to screening Current treatment with more than 2 antihypertensive medications Secondary hypertension from uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateral renal artery stenosis in a single kidney Serum albumin < 2.5 g/dL Major organ or bone marrow transplantation except for prior kidney transplantation of at least 6 months and with stable renal function meeting the inclusion criteria

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olmesartan<br>Children less than 6 years old received 0.3 mg/kg. Children 6 years old or older received 40 mg, if they weighed 35 kg or more; 20 mg if they weighed less than 35 kg. | Drug: Olmesartan medoxomil<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t) |  | 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 |  | PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing | 
| For Olmesartan, the Elimination Constant Rate |  | 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 |  | 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 |  | 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 |  | PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing | 
| For Olmesartan, the Apparent Oral Clearance |  | 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 |  | PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Olmesartan PK in children