E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hypertension, Chronic Kidney Disease, Nephrotic Syndrome |
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E.1.1.1 | Medical condition in easily understood language |
Chronic Kidney Disease, High Blood Pressure, Kidney Diseases |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary objective
• To determine the single-dose PK of valsartan 20 mg or 40 mg in Japanese pediatric patients from 6 to 14 years of age. |
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E.2.2 | Secondary objectives of the trial |
Secondary objective
• To assess the safety and tolerability of valsartan 20 mg or 40 mg in Japanese pediatric patients from 6 to 14 years of age. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•apanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome
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E.4 | Principal exclusion criteria |
GFR < 30 mL/min/1.73 m2
Inability to safely tolerate the temporary discontinuation of concomitant antihypertensive medications (expect amlodipine or atenolol) from 24 hours prior to study drug administration to study completion.
Inability to safely tolerate the temporary discontinuation of any drug known or suspected to effect hepatic or renal clearance capacity from 24 hours prior to study drug administration to study completion (this includes drugs that are known to cause induction or inhibition of hepatic enzymes). |
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E.5 End points |
E.5.1 | Primary end point(s) |
AUC of valsartan in plasma [ Time Frame: Up to 24 hours post-dose ] [ Designated as safety issue: No ]
Cmax of valsartan in plasma [ Time Frame: Up to 24 hours post-dose ] [ Designated as safety issue: No ]
Tmax of valsartan in plasma [ Time Frame: Up to 24 hours post-dose ] [ Designated as safety issue: No ]
T1/2 of valsartan in plasma [ Time Frame: Up to 24 hours post-dose ] [ Designated as safety issue: No ]
CL/F of valsartan in plasma [ Time Frame: Up to 24 hours post-dose ] [ Designated as safety issue: No ]
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Blood collection at pre-dose, 2, 4, 6, 8 and 24 hours post-dose. |
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E.5.2 | Secondary end point(s) |
ECG evaluations
Standard clinical laboratory evaluations
Vital signs
Physical examination
Number and severity of adverse events |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
ECG evaluations [ Time Frame: 24 hours post-dose ] [ Designated as safety issue: Yes ]
Standard clinical laboratory evaluations [ Time Frame: 24 hours post-dose ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: 2, 4, and 24 hours post-dose ] [ Designated as safety issue: Yes ]
Physical examination [ Time Frame: 24 hours post-dose ] [ Designated as safety issue: Yes ]
Number and severity of adverse events [ Time Frame: Up to 24 hours post-dose ] [ Designated as safety issue: Yes ]
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 27 |