Clinical trial NCT00151814: Olmesartan Pediatric Pharmacokinetic (PK) Study
Official title: An Open-label Study of the Single-dose Pharmacokinetics of Olmesartan Medoxomil in Pediatric Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Keywords: Olmesartan PK in children
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 24
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with hypertension in ages 12 months - 16 years


Eligibility criteria: 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

Primary outcomes:
measure: For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)
timeFrame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
measure: For Olmesartan, Area Under the Concentration-time Curve From the Time of the Dose to Infinity
timeFrame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
measure: For Olmesartan, the Elimination Constant Rate
timeFrame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
measure: For Olmesartan, the Maximum Plasma Concentration Over the Entire Sampling Phase
timeFrame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
measure: Foe Olmesartan, the Time of Maximum Plasma Concentration
timeFrame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
measure: For Olmesartan, the Elimination Half-life of the Drug in Plasma
timeFrame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
measure: For Olmesartan, the Apparent Oral Clearance
timeFrame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
measure: For Olmesartan, the Apparent Oral Volume of Distribution
timeFrame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: La Jolla
country: United States
state: California
city: Louisville
country: United States
state: Kentucky
city: Kansas City
country: United States
state: Missouri
city: Cleveland
country: United States
state: Ohio
Study officials:
References:
citation: Wells TG, Blowey DL, Sullivan JE, Blumer J, Sherbotie JR, Song S, Rohatagi S, Heyrman R, Salazar DE. Pharmacokinetics of olmesartan medoxomil in pediatric patients with hypertension. Paediatr Drugs. 2012 Dec 1;14(6):401-9. doi: 10.2165/11631450-000000000-00000.