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Trial record 12 of 139 for:    OLMESARTAN

Olmesartan Pediatric Pharmacokinetic (PK) Study

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ClinicalTrials.gov Identifier: NCT00151814
Recruitment Status : Completed
First Posted : September 9, 2005
Results First Posted : April 9, 2010
Last Update Posted : April 15, 2010
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 9, 2005
Results First Submitted Date  ICMJE March 19, 2010
Results First Posted Date  ICMJE April 9, 2010
Last Update Posted Date April 15, 2010
Study Start Date  ICMJE September 2005
Actual 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Arms  ICMJE 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 * 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.

*   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
Actual Enrollment  ICMJE
 (submitted: March 10, 2008)
24
Original Enrollment  ICMJE
 (submitted: September 8, 2005)
40
Actual Study Completion Date  ICMJE February 2008
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00151814
Other Study ID Numbers  ICMJE CS0866-A-U102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Melino, PhD, Daiichi Sankyo
Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account 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