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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
Results First Received: March 19, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Intervention: Drug: Olmesartan medoxomil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.
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.
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.

Participant Flow:   Overall Study
    Olmesartan Group - 2 to 5 Years Old     Olmesartan Group - 6 to 12 Years Old     Olmesartan Group - 13 to 16 Years Old  
STARTED     4     10     10  
COMPLETED     4     10     10  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
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.
Total Total of all reporting groups

Baseline Measures
    Olmesartan Group - 2 to 5 Years Old     Olmesartan Group - 6 to 12 Years Old     Olmesartan Group - 13 to 16 Years Old     Total  
Number of Participants  
[units: participants]
  4     10     10     24  
Age  
[units: years]
Mean ± Standard Deviation
  4.8  ± 0.50     10.2  ± 1.03     14.8  ± 1.03     11.2  ± 3.76  
Gender  
[units: participants]
       
Female     3     5     5     13  
Male     1     5     5     11  
Region of Enrollment  
[units: participants]
       
United States     4     10     10     24  
Height  
[units: cm]
Mean ± Standard Deviation
  116.7  ± 9.01     151.8  ± 9.44     165.5  ± 9.74     151.6  ± 19.44  
Weight  
[units: kg]
Mean ± Standard Deviation
  32.0  ± 16.31     70.3  ± 20.53     86.3  ± 29.50     70.6  ± 30.09  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Primary:   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 ]

4.  Primary:   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 ]

5.  Primary:   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 ]

6.  Primary:   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 ]

7.  Primary:   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 ]

8.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Howard Kessler
Organization: Daiichi Sankyo
phone: 732-590-5032
e-mail: hmkessler@dsi.com


No publications provided


Responsible Party: Michael Melino, PhD, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00151814     History of Changes
Other Study ID Numbers: CS0866-A-U102
Study First Received: September 8, 2005
Results First Received: March 19, 2010
Last Updated: April 12, 2010
Health Authority: United States: Food and Drug Administration