Phase 1
Completed N=24
Olmesartan Pediatric Pharmacokinetic (PK) Study
Source: ClinicalTrials.gov NCT00151814 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2010
Primary outcomePrimary: For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t) — 7874; 5851 ng/mL*hr
Summary
Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with hypertension in ages 12 months - 16 years
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t) |
7874; 5851 | — |
| PRIMARY For Olmesartan, Area Under the Concentration-time Curve From the Time of the Dose to Infinity |
7988; 5982 | — |
| PRIMARY For Olmesartan, the Elimination Constant Rate |
0.090; 0.079 | — |
| PRIMARY For Olmesartan, the Maximum Plasma Concentration Over the Entire Sampling Phase |
1227; 895 | — |
| PRIMARY Foe Olmesartan, the Time of Maximum Plasma Concentration |
2.8; 2.5 | — |
| PRIMARY For Olmesartan, the Elimination Half-life of the Drug in Plasma |
8.4; 9.1 | — |
| PRIMARY For Olmesartan, the Apparent Oral Clearance |
4.3; 6.1 | — |
| PRIMARY For Olmesartan, the Apparent Oral Volume of Distribution |
50.9; 81.3 | — |
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
Data sourced from ClinicalTrials.gov (NCT00151814). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.