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Trial record 10 of 134 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.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Intervention Drug: Olmesartan medoxomil
Enrollment 24
Recruitment Details 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 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.
Arm/Group Title Olmesartan Group - 2 to 5 Years Old Olmesartan Group - 6 to 12 Years Old Olmesartan Group - 13 to 16 Years Old
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 4 10 10
Completed 4 10 10
Not Completed 0 0 0
Arm/Group Title Olmesartan Group - 2 to 5 Years Old Olmesartan Group - 6 to 12 Years Old Olmesartan Group - 13 to 16 Years Old Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 4 10 10 24
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 10 participants 10 participants 24 participants
4.8  (0.50) 10.2  (1.03) 14.8  (1.03) 11.2  (3.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 10 participants 10 participants 24 participants
Female
3
  75.0%
5
  50.0%
5
  50.0%
13
  54.2%
Male
1
  25.0%
5
  50.0%
5
  50.0%
11
  45.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 10 participants 10 participants 24 participants
4 10 10 24
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 4 participants 10 participants 10 participants 24 participants
116.7  (9.01) 151.8  (9.44) 165.5  (9.74) 151.6  (19.44)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 4 participants 10 participants 10 participants 24 participants
32.0  (16.31) 70.3  (20.53) 86.3  (29.50) 70.6  (30.09)
1.Primary Outcome
Title For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)
Hide Description [Not Specified]
Time Frame PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.
Arm/Group Title 6-12 Years of Age Olmesartan Group 13-16 Years of Age Olmesartan Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: ng/mL*hr
7874  (2913) 5851  (2083)
2.Primary Outcome
Title For Olmesartan, Area Under the Concentration-time Curve From the Time of the Dose to Infinity
Hide Description [Not Specified]
Time Frame PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.
Arm/Group Title 6-12 Years of Age Olmesartan Group 13-16 Years of Age Olmesartan Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: ng/mL*hr
7988  (2913) 5982  (2130)
3.Primary Outcome
Title For Olmesartan, the Elimination Constant Rate
Hide Description [Not Specified]
Time Frame PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.
Arm/Group Title 6-12 Years of Age Olmesartan Group 13-16 Years of Age Olmesartan Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: L/hr
0.090  (0.029) 0.079  (0.016)
4.Primary Outcome
Title For Olmesartan, the Maximum Plasma Concentration Over the Entire Sampling Phase
Hide Description [Not Specified]
Time Frame PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.
Arm/Group Title 6-12 Years of Age Olmesartan Group 13-16 Years of Age Olmesartan Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
1227  (451) 895  (262)
5.Primary Outcome
Title Foe Olmesartan, the Time of Maximum Plasma Concentration
Hide Description [Not Specified]
Time Frame PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.
Arm/Group Title 6-12 Years of Age Olmesartan Group 13-16 Years of Age Olmesartan Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: hr
2.8  (1.3) 2.5  (1.1)
6.Primary Outcome
Title For Olmesartan, the Elimination Half-life of the Drug in Plasma
Hide Description [Not Specified]
Time Frame PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.
Arm/Group Title 6-12 Years of Age Olmesartan Group 13-16 Years of Age Olmesartan Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: hr
8.4  (2.4) 9.1  (1.9)
7.Primary Outcome
Title For Olmesartan, the Apparent Oral Clearance
Hide Description [Not Specified]
Time Frame PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.
Arm/Group Title 6-12 Years of Age Olmesartan Group 13-16 Years of Age Olmesartan Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: L/hr
4.3  (1.9) 6.1  (2.6)
8.Primary Outcome
Title For Olmesartan, the Apparent Oral Volume of Distribution
Hide Description [Not Specified]
Time Frame PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.
Arm/Group Title 6-12 Years of Age Olmesartan Group 13-16 Years of Age Olmesartan Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: L
50.9  (20.7) 81.3  (42.1)
Time Frame <3 days
Adverse Event Reporting Description Adverse events observed by the Investigator, or reported by the subject, and any remedial action taken, were recorded in the CRF by the Investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the Investigator’s opinion of the causal relationship to the treatment.
 
Arm/Group Title Olmesartan Group - 2 to 5 Years Old Olmesartan Group - 6 to 12 Years Old Olmesartan Group - 13 to 16 Years Old
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Olmesartan Group - 2 to 5 Years Old Olmesartan Group - 6 to 12 Years Old Olmesartan Group - 13 to 16 Years Old
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Olmesartan Group - 2 to 5 Years Old Olmesartan Group - 6 to 12 Years Old Olmesartan Group - 13 to 16 Years Old
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Olmesartan Group - 2 to 5 Years Old Olmesartan Group - 6 to 12 Years Old Olmesartan Group - 13 to 16 Years Old
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/4 (25.00%)   2/10 (20.00%)   1/10 (10.00%) 
Gastrointestinal disorders       
Abdominal pain upper  1  0/4 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
Diarrhea  1  0/4 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
General disorders       
Fatigue  1  1/4 (25.00%)  0/10 (0.00%)  0/10 (0.00%) 
Investigations       
Abnormal urine analysis  1  0/4 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
Nervous system disorders       
Headache  1  1/4 (25.00%)  0/10 (0.00%)  0/10 (0.00%) 
Somnolence  1  0/4 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.1)
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
Layout table for Results Point of Contact information
Name/Title: Howard Kessler
Organization: Daiichi Sankyo
Phone: 732-590-5032
EMail: hmkessler@dsi.com
Layout table for additonal information
Responsible Party: Michael Melino, PhD, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00151814     History of Changes
Other Study ID Numbers: CS0866-A-U102
First Submitted: September 8, 2005
First Posted: September 9, 2005
Results First Submitted: March 19, 2010
Results First Posted: April 9, 2010
Last Update Posted: April 15, 2010