Olmesartan Pediatric Pharmacokinetic (PK) Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00151814

Enrollment

Registered

2005-09-09

Start date

2005-09-30

Completion date

2008-02-29

Last updated

2010-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Olmesartan PK in children

Brief summary

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

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Months to 16 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)	PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, Area Under the Concentration-time Curve From the Time of the Dose to Infinity	PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Elimination Constant Rate	PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Maximum Plasma Concentration Over the Entire Sampling Phase	PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Foe Olmesartan, the Time of Maximum Plasma Concentration	PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Elimination Half-life of the Drug in Plasma	PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Apparent Oral Clearance	PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
For Olmesartan, the Apparent Oral Volume of Distribution	PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

The 2-5 years old cohort had only 4 participants and their data were not sufficient for meaningful analysis. No participants in the 12-23 month old category were enrolled.

Participants by arm

Arm	Count
Olmesartan Group - 2 to 5 Years Old Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children \<6 years old was 0.3 mg.kg; the dose for children \> or = to 6 years of age and \> or = to 35 kg was 40mg; for \<35 kg the dose was 20 mg.	4
Olmesartan Group - 6 to 12 Years Old Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children \<6 years old was 0.3 mg.kg; the dose for children \> or = to 6 years of age and \> or = to 35 kg was 40mg; for \<35 kg the dose was 20 mg.	10
Olmesartan Group - 13 to 16 Years Old Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children \<6 years old was 0.3 mg.kg; the dose for children \> or = to 6 years of age and \> or = to 35 kg was 40mg; for \<35 kg the dose was 20 mg.	10
Total	24

Baseline characteristics

Characteristic	Olmesartan Group - 2 to 5 Years Old	Olmesartan Group - 6 to 12 Years Old	Olmesartan Group - 13 to 16 Years Old	Total
Age Continuous	4.8 years STANDARD_DEVIATION 0.5	10.2 years STANDARD_DEVIATION 1.03	14.8 years STANDARD_DEVIATION 1.03	11.2 years STANDARD_DEVIATION 3.76
Height	116.7 cm STANDARD_DEVIATION 9.01	151.8 cm STANDARD_DEVIATION 9.44	165.5 cm STANDARD_DEVIATION 9.74	151.6 cm STANDARD_DEVIATION 19.44
Region of Enrollment United States	4 participants	10 participants	10 participants	24 participants
Sex: Female, Male Female	3 Participants	5 Participants	5 Participants	13 Participants
Sex: Female, Male Male	1 Participants	5 Participants	5 Participants	11 Participants
Weight	32.0 kg STANDARD_DEVIATION 16.31	70.3 kg STANDARD_DEVIATION 20.53	86.3 kg STANDARD_DEVIATION 29.5	70.6 kg STANDARD_DEVIATION 30.09

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	1 / 4	2 / 10	1 / 10
serious Total, serious adverse events	0 / 4	0 / 10	0 / 10