Olmesartan Pediatric Pharmacokinetic (PK) Study
An Open-label Study of the Single-dose Pharmacokinetics of Olmesartan Medoxomil in Pediatric Patients With Hypertension
1 other identifier
interventional
24
1 country
5
Brief Summary
Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with hypertension in ages 12 months - 16 years
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hypertension
Started Sep 2005
Longer than P75 for phase_1 hypertension
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 9, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
April 9, 2010
CompletedApril 15, 2010
April 1, 2010
2.4 years
September 8, 2005
March 19, 2010
April 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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
Study Arms (1)
Olmesartan
EXPERIMENTALChildren 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.
Interventions
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (5)
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
La Jolla, California, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
Cleveland, Ohio, United States
Related Publications (1)
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.
PMID: 22880942DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Howard Kessler
- Organization
- Daiichi Sankyo
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 9, 2005
Study Start
September 1, 2005
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
April 15, 2010
Results First Posted
April 9, 2010
Record last verified: 2010-04