Status:
COMPLETED
Olmesartan Pediatric Pharmacokinetic (PK) Study
Lead Sponsor:
Daiichi Sankyo
Conditions:
Hypertension
Eligibility:
All Genders
12-16 years
Phase:
PHASE1
Brief Summary
Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with hypertension in ages 12 months - 16 years
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00151814
Start Date
September 1 2005
End Date
February 1 2008
Last Update
April 15 2010
Active Locations (5)
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1
Little Rock, Arkansas, United States
2
La Jolla, California, United States
3
Louisville, Kentucky, United States
4
Kansas City, Missouri, United States