Trial Outcomes & Findings for Olmesartan Pediatric Pharmacokinetic (PK) Study (NCT NCT00151814)
NCT ID: NCT00151814
Last Updated: 2010-04-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing
Results posted on
2010-04-15
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
10
|
10
|
|
Overall Study
COMPLETED
|
4
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Olmesartan Pediatric Pharmacokinetic (PK) Study
Baseline characteristics by cohort
| Measure |
Olmesartan Group - 2 to 5 Years Old
n=4 Participants
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
n=10 Participants
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
n=10 Participants
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
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
4.8 years
STANDARD_DEVIATION 0.50 • n=5 Participants
|
10.2 years
STANDARD_DEVIATION 1.03 • n=7 Participants
|
14.8 years
STANDARD_DEVIATION 1.03 • n=5 Participants
|
11.2 years
STANDARD_DEVIATION 3.76 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Height
|
116.7 cm
STANDARD_DEVIATION 9.01 • n=5 Participants
|
151.8 cm
STANDARD_DEVIATION 9.44 • n=7 Participants
|
165.5 cm
STANDARD_DEVIATION 9.74 • n=5 Participants
|
151.6 cm
STANDARD_DEVIATION 19.44 • n=4 Participants
|
|
Weight
|
32.0 kg
STANDARD_DEVIATION 16.31 • n=5 Participants
|
70.3 kg
STANDARD_DEVIATION 20.53 • n=7 Participants
|
86.3 kg
STANDARD_DEVIATION 29.50 • n=5 Participants
|
70.6 kg
STANDARD_DEVIATION 30.09 • n=4 Participants
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosingPopulation: 24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.
Outcome measures
| Measure |
6-12 Years of Age Olmesartan Group
n=10 Participants
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.
|
13-16 Years of Age Olmesartan Group
n=10 Participants
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.
|
|---|---|---|
|
For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)
|
7874 ng/mL*hr
Standard Deviation 2913
|
5851 ng/mL*hr
Standard Deviation 2083
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosingPopulation: 24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.
Outcome measures
| Measure |
6-12 Years of Age Olmesartan Group
n=10 Participants
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.
|
13-16 Years of Age Olmesartan Group
n=10 Participants
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.
|
|---|---|---|
|
For Olmesartan, Area Under the Concentration-time Curve From the Time of the Dose to Infinity
|
7988 ng/mL*hr
Standard Deviation 2913
|
5982 ng/mL*hr
Standard Deviation 2130
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosingPopulation: 24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.
Outcome measures
| Measure |
6-12 Years of Age Olmesartan Group
n=10 Participants
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.
|
13-16 Years of Age Olmesartan Group
n=10 Participants
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.
|
|---|---|---|
|
For Olmesartan, the Elimination Constant Rate
|
0.090 L/hr
Standard Deviation 0.029
|
0.079 L/hr
Standard Deviation 0.016
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosingPopulation: 24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.
Outcome measures
| Measure |
6-12 Years of Age Olmesartan Group
n=10 Participants
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.
|
13-16 Years of Age Olmesartan Group
n=10 Participants
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.
|
|---|---|---|
|
For Olmesartan, the Maximum Plasma Concentration Over the Entire Sampling Phase
|
1227 ng/mL
Standard Deviation 451
|
895 ng/mL
Standard Deviation 262
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosingPopulation: 24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.
Outcome measures
| Measure |
6-12 Years of Age Olmesartan Group
n=10 Participants
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.
|
13-16 Years of Age Olmesartan Group
n=10 Participants
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.
|
|---|---|---|
|
Foe Olmesartan, the Time of Maximum Plasma Concentration
|
2.8 hr
Standard Deviation 1.3
|
2.5 hr
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosingPopulation: 24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.
Outcome measures
| Measure |
6-12 Years of Age Olmesartan Group
n=10 Participants
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.
|
13-16 Years of Age Olmesartan Group
n=10 Participants
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.
|
|---|---|---|
|
For Olmesartan, the Elimination Half-life of the Drug in Plasma
|
8.4 hr
Standard Deviation 2.4
|
9.1 hr
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosingPopulation: 24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.
Outcome measures
| Measure |
6-12 Years of Age Olmesartan Group
n=10 Participants
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.
|
13-16 Years of Age Olmesartan Group
n=10 Participants
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.
|
|---|---|---|
|
For Olmesartan, the Apparent Oral Clearance
|
4.3 L/hr
Standard Deviation 1.9
|
6.1 L/hr
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosingPopulation: 24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.
Outcome measures
| Measure |
6-12 Years of Age Olmesartan Group
n=10 Participants
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.
|
13-16 Years of Age Olmesartan Group
n=10 Participants
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.
|
|---|---|---|
|
For Olmesartan, the Apparent Oral Volume of Distribution
|
50.9 L
Standard Deviation 20.7
|
81.3 L
Standard Deviation 42.1
|
Adverse Events
Olmesartan Group - 2 to 5 Years Old
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Olmesartan Group - 6 to 12 Years Old
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Olmesartan Group - 13 to 16 Years Old
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Olmesartan Group - 2 to 5 Years Old
n=4 participants at risk
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
n=10 participants at risk
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
n=10 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • <3 days
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.
|
10.0%
1/10 • <3 days
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.
|
0.00%
0/10 • <3 days
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.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • <3 days
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.
|
10.0%
1/10 • <3 days
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.
|
0.00%
0/10 • <3 days
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.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • <3 days
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.
|
0.00%
0/10 • <3 days
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.
|
0.00%
0/10 • <3 days
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.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • <3 days
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.
|
10.0%
1/10 • <3 days
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.
|
0.00%
0/10 • <3 days
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.
|
|
General disorders
Fatigue
|
25.0%
1/4 • <3 days
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.
|
0.00%
0/10 • <3 days
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.
|
0.00%
0/10 • <3 days
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.
|
|
Investigations
Abnormal urine analysis
|
0.00%
0/4 • <3 days
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.
|
0.00%
0/10 • <3 days
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.
|
10.0%
1/10 • <3 days
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place