Olmesartan Pediatric Pharmacokinetic (PK) Study

This study has been completed.

Sponsor:

Information provided by:

Daiichi Sankyo Inc.

ClinicalTrials.gov Identifier:

NCT00151814

First received: September 8, 2005

Last updated: April 12, 2010

Last verified: April 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	September 8, 2005
Last Updated Date	April 12, 2010
Start Date ^ICMJE	September 2005
Primary Completion Date	February 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 12, 2010)	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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: September 8, 2005)	Pharmacokinetic parameters
Change History	Complete list of historical versions of study NCT00151814 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE (submitted: September 8, 2005)	Safety
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Olmesartan Pediatric Pharmacokinetic (PK) Study
Official Title ^ICMJE	An Open-label Study of the Single-dose Pharmacokinetics of Olmesartan Medoxomil in Pediatric Patients With Hypertension
Brief Summary	Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with hypertension in ages 12 months - 16 years
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hypertension
Intervention ^ICMJE	Drug: Olmesartan 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 Arm (s)	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. Intervention: Drug: Olmesartan medoxomil
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	24
Completion Date	February 2008
Primary Completion Date	February 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	12 Months to 16 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00151814
Other Study ID Numbers ^ICMJE	CS0866-A-U102
Has Data Monitoring Committee	Not Provided
Responsible Party	Michael Melino, PhD, Daiichi Sankyo
Study Sponsor ^ICMJE	Daiichi Sankyo Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Daiichi Sankyo Inc.
Verification Date	April 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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