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Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with hypertension in ages 12 months - 16 years
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olmesartan | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olmesartan medoxomil | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t) | 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 | PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing | |
| For Olmesartan, the Elimination Constant Rate | 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 | 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 | 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 | PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing | |
| For Olmesartan, the Apparent Oral Clearance | 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 | PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22880942 | Derived | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t) | 24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed. | Posted | Mean | Standard Deviation | ng/mL*hr | PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing |
|
<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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Howard Kessler | Daiichi Sankyo | 732-590-5032 | hmkessler@dsi.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068557 | Olmesartan Medoxomil |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| La Jolla |
| California |
| United States |
| Louisville | Kentucky | United States |
| Kansas City | Missouri | United States |
| Cleveland | Ohio | United States |
| 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
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.
|
|
| Primary | For Olmesartan, Area Under the Concentration-time Curve From the Time of the Dose to Infinity | 24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed. | Posted | Mean | Standard Deviation | ng/mL*hr | PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing |
|
|
|
| Primary | For Olmesartan, the Elimination Constant Rate | 24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed. | Posted | Mean | Standard Deviation | L/hr | PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing |
|
|
|
| Primary | For Olmesartan, the Maximum Plasma Concentration Over the Entire Sampling Phase | 24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed. | Posted | Mean | Standard Deviation | ng/mL | PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing |
|
|
|
| Primary | Foe Olmesartan, the Time of Maximum Plasma Concentration | 24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed. | Posted | Mean | Standard Deviation | hr | PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing |
|
|
|
| Primary | For Olmesartan, the Elimination Half-life of the Drug in Plasma | 24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed. | Posted | Mean | Standard Deviation | hr | PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing |
|
|
|
| Primary | For Olmesartan, the Apparent Oral Clearance | 24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed. | Posted | Mean | Standard Deviation | L/hr | PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing |
|
|
|
| Primary | For Olmesartan, the Apparent Oral Volume of Distribution | 24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed. | Posted | Mean | Standard Deviation | L | PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing |
|
|
|
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | 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. | 0 | 10 | 2 | 10 |
| EG002 | 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. | 0 | 10 | 1 | 10 |
| Diarrhea | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (8.1) | Systematic Assessment |
|
| Abnormal urine analysis | Investigations | MedDRA (8.1) | Systematic Assessment |
|
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| D013777 |
| Tetrazoles |