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CompletedNCT00151814Updated Apr 15, 2010Results posted

Olmesartan Pediatric Pharmacokinetic (PK) Study

A Phase 1 interventional study of Olmesartan medoxomil in Hypertension, sponsored by Daiichi Sankyo. Completed at 5 sites in United States. Open to participants aged 12 Months to 16 Years. Per ClinicalTrials.gov, last updated 2010-04-15.

Sponsored by Daiichi Sankyo · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
12 Months to 16 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Hypertension

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Keywords

  • Olmesartan PK in children
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 24 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Daiichi Sankyo is the lead sponsor of 316 studies on the registry; 35 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Olmesartan

    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.

    Drug: Olmesartan medoxomil

Interventions

  • DrugOlmesartan medoxomil

    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.

06

What researchers measure

Primary outcomes

  1. For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)

    Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

  2. For Olmesartan, Area Under the Concentration-time Curve From the Time of the Dose to Infinity

    Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

  3. For Olmesartan, the Elimination Constant Rate

    Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

  4. For Olmesartan, the Maximum Plasma Concentration Over the Entire Sampling Phase

    Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

  5. Foe Olmesartan, the Time of Maximum Plasma Concentration

    Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

  6. For Olmesartan, the Elimination Half-life of the Drug in Plasma

    Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

  7. For Olmesartan, the Apparent Oral Clearance

    Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

  8. For Olmesartan, the Apparent Oral Volume of Distribution

    Time frame: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

07

Results

Posted Apr 9, 2010

Participant flow

The recruitment period was from September 2005 to February 2008. This period lasted for this length of time because of difficulties in recruiting participants. Children from 12 months old to 16 years old were to be enrolled.

Participant flow — Overall Study
MilestoneOlmesartan Group - 2 to 5 Years OldOlmesartan Group - 6 to 12 Years OldOlmesartan Group - 13 to 16 Years Old
Started41010
Completed41010
Not completed000

Outcome measures

PrimaryFor Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)
Time frame:
PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Reported as:
Mean · ng/mL*hr
For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)
ng/mL*hr6-12 Years of Age Olmesartan Group13-16 Years of Age Olmesartan Group
For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)7874 ± 29135851 ± 2083
PrimaryFor Olmesartan, Area Under the Concentration-time Curve From the Time of the Dose to Infinity
Time frame:
PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Reported as:
Mean · ng/mL*hr
For Olmesartan, Area Under the Concentration-time Curve From the Time of the Dose to Infinity
ng/mL*hr6-12 Years of Age Olmesartan Group13-16 Years of Age Olmesartan Group
For Olmesartan, Area Under the Concentration-time Curve From the Time of the Dose to Infinity7988 ± 29135982 ± 2130
PrimaryFor Olmesartan, the Elimination Constant Rate
Time frame:
PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Reported as:
Mean · L/hr
For Olmesartan, the Elimination Constant Rate
L/hr6-12 Years of Age Olmesartan Group13-16 Years of Age Olmesartan Group
For Olmesartan, the Elimination Constant Rate0.090 ± 0.0290.079 ± 0.016
PrimaryFor Olmesartan, the Maximum Plasma Concentration Over the Entire Sampling Phase
Time frame:
PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Reported as:
Mean · ng/mL
For Olmesartan, the Maximum Plasma Concentration Over the Entire Sampling Phase
ng/mL6-12 Years of Age Olmesartan Group13-16 Years of Age Olmesartan Group
For Olmesartan, the Maximum Plasma Concentration Over the Entire Sampling Phase1227 ± 451895 ± 262
PrimaryFoe Olmesartan, the Time of Maximum Plasma Concentration
Time frame:
PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Reported as:
Mean · hr
Foe Olmesartan, the Time of Maximum Plasma Concentration
hr6-12 Years of Age Olmesartan Group13-16 Years of Age Olmesartan Group
Foe Olmesartan, the Time of Maximum Plasma Concentration2.8 ± 1.32.5 ± 1.1
PrimaryFor Olmesartan, the Elimination Half-life of the Drug in Plasma
Time frame:
PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Reported as:
Mean · hr
For Olmesartan, the Elimination Half-life of the Drug in Plasma
hr6-12 Years of Age Olmesartan Group13-16 Years of Age Olmesartan Group
For Olmesartan, the Elimination Half-life of the Drug in Plasma8.4 ± 2.49.1 ± 1.9
PrimaryFor Olmesartan, the Apparent Oral Clearance
Time frame:
PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Reported as:
Mean · L/hr
For Olmesartan, the Apparent Oral Clearance
L/hr6-12 Years of Age Olmesartan Group13-16 Years of Age Olmesartan Group
For Olmesartan, the Apparent Oral Clearance4.3 ± 1.96.1 ± 2.6
PrimaryFor Olmesartan, the Apparent Oral Volume of Distribution
Time frame:
PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Reported as:
Mean · L
For Olmesartan, the Apparent Oral Volume of Distribution
L6-12 Years of Age Olmesartan Group13-16 Years of Age Olmesartan Group
For Olmesartan, the Apparent Oral Volume of Distribution50.9 ± 20.781.3 ± 42.1

Adverse events

Collected over <3 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Olmesartan Group - 2 to 5 Years Old—0/4 (0%)1/4 (25%)
Olmesartan Group - 6 to 12 Years Old—0/10 (0%)2/10 (20%)
Olmesartan Group - 13 to 16 Years Old—0/10 (0%)1/10 (10%)
Most frequent other events
Most frequent other events
EventOlmesartan Group - 2 to 5 Years OldOlmesartan Group - 6 to 12 Years OldOlmesartan Group - 13 to 16 Years Old
HeadacheNervous system disorders1/40/100/10
FatigueGeneral disorders1/40/100/10
Abdominal pain upperGastrointestinal disorders0/41/100/10
DiarrheaGastrointestinal disorders0/41/100/10
SomnolenceNervous system disorders0/41/100/10
Abnormal urine analysisInvestigations0/40/101/10

Baseline characteristics

Age Continuous
Age Continuous(years)Olmesartan Group - 2 to 5 Years OldOlmesartan Group - 6 to 12 Years OldOlmesartan Group - 13 to 16 Years OldTotal
Mean4.8 ± 0.5010.2 ± 1.0314.8 ± 1.0311.2 ± 3.76
Sex: Female, Male
Sex: Female, Male(Participants)Olmesartan Group - 2 to 5 Years OldOlmesartan Group - 6 to 12 Years OldOlmesartan Group - 13 to 16 Years OldTotal
Female35513
Male15511
Region of Enrollment
Region of Enrollment(participants)Olmesartan Group - 2 to 5 Years OldOlmesartan Group - 6 to 12 Years OldOlmesartan Group - 13 to 16 Years OldTotal
United States4101024
Height
Height(cm)Olmesartan Group - 2 to 5 Years OldOlmesartan Group - 6 to 12 Years OldOlmesartan Group - 13 to 16 Years OldTotal
Mean116.7 ± 9.01151.8 ± 9.44165.5 ± 9.74151.6 ± 19.44
Weight
Weight(kg)Olmesartan Group - 2 to 5 Years OldOlmesartan Group - 6 to 12 Years OldOlmesartan Group - 13 to 16 Years OldTotal
Mean32.0 ± 16.3170.3 ± 20.5386.3 ± 29.5070.6 ± 30.09
08

Study locations

5 sites
  • Little Rock, Arkansas, United States
  • La Jolla, California, United States
  • Louisville, Kentucky, United States
  • Kansas City, Missouri, United States
  • Cleveland, Ohio, United States
09

References and documents

Publications

  • Wells TG, Blowey DL, Sullivan JE, Blumer J, Sherbotie JR, Song S, Rohatagi S, Heyrman R, Salazar DE. Pharmacokinetics of olmesartan medoxomil in pediatric patients with hypertension. Paediatr Drugs. 2012 Dec 1;14(6):401-9. doi: 10.2165/11631450-000000000-00000. PubMed 22880942 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00151814
Lead sponsor
Daiichi Sankyo
First posted
Sep 9, 2005
Start date
Sep 2005
Primary completion
Feb 2008
Completion
Feb 2008
Results posted
Apr 9, 2010
Last update
Apr 15, 2010
View the source record on ClinicalTrials.gov ↗

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