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

September 8, 2005
April 12, 2010
September 2005
February 2008   (final data collection date for primary outcome measure)
  • 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 ]
Pharmacokinetic parameters
Complete list of historical versions of study NCT00151814 on ClinicalTrials.gov Archive Site
Not Provided
Safety
Not Provided
Not Provided
 
Olmesartan Pediatric Pharmacokinetic (PK) Study
An Open-label Study of the Single-dose Pharmacokinetics of Olmesartan Medoxomil in Pediatric Patients With Hypertension

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
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.
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
February 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
12 Months to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00151814
CS0866-A-U102
Not Provided
Michael Melino, PhD, Daiichi Sankyo
Daiichi Sankyo Inc.
Not Provided
Not Provided
Daiichi Sankyo Inc.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP