Olmesartan Pediatric Pharmacokinetic (PK) Study
- Registration Number
- NCT00151814
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with hypertension in ages 12 months - 16 years
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Olmesartan Olmesartan medoxomil 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method