Olmesartan Pediatric Pharmacokinetic (PK) Study
Completed · Phase 1
Conditions studied: Hypertension
In brief
Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with hypertension in ages 12 months - 16 years
Key facts
- Study ID
- NCT00151814
- Run by
- Daiichi Sankyo
- People needed
- 24
- Starts
- 2005-09-01
- Expected to finish
- 2008-02-01
- Last updated by the study team
- 2010-04-15
Who can join
Age: 1 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Study site — Little Rock, Arkansas, United States
- Study site — La Jolla, California, United States
- Study site — Louisville, Kentucky, United States
- Study site — Kansas City, Missouri, United States
- Study site — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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