CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Olmesartan medoxomildrug
Likely dose
0.3 mg/kg for children <6 years; 20-40 mg tablets for children ≥6 years (weight-dependent)AI-extracted
Key inclusion· 4
  • ✓Age 12 months to 16 years inclusive
  • ✓Currently treated for hypertension, or if untreated: SBP ≥95th percentile for gender/height-for-age, or SBP/DBP ≥90th percentile with diabetes or family history of hypertension
  • ✓GFR ≥30 mL/min/1.73 m² estimated using Schwartz equation
  • ✓Parental/guardian informed consent and subject assent
Key exclusion· 6
  • ✕Clinically significant cardiac, gastrointestinal, hematologic, hepatic, neurologic, or pulmonary disorder (except asthma)
  • ✕History of severe or symptomatic hypertension with stroke, seizures, encephalopathy, or significant neurologic findings within 1 year prior to screening
  • ✕Current treatment with more than 2 antihypertensive medications
  • ✕Secondary hypertension from uncorrected coarctation of aorta, bilateral renal artery stenosis, or unilateral renal artery stenosis in single kidney

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00151814
NCT00151814Phase 1Completed
CompareCT.gov

An Open-label Study of the Single-dose Pharmacokinetics of Olmesartan Medoxomil in Pediatric Patients With Hypertension

Daiichi Sankyo·interventional·Posted Sep 9, 2005·Updated Apr 15, 2010

In Brief

A Phase 1 clinical trial evaluating Olmesartan medoxomil for Hypertension. Completed, enrolled 24 participants across 5 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 9, 2005
Enrollment StartSep 1, 2005
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 20.8 years ago

Interventions

Olmesartan medoxomildrug

Children less than 6 years old: oral suspension or tablets equal to 0.3 mg/kg; 20 mg or 40 mg tablets for older children depending on weight.