E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hypertension in pediatric subjects 10020772 |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020772 |
E.1.2 | Term | Hypertension |
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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 |
To characterize the dose response relantionship of candesartan cilexetil once-daily in hypertensive pediatric subjects 1to 6 years of age |
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E.2.2 | Secondary objectives of the trial |
To further evaluate the antihypertension effects and the safety of candesartan cilexetil in hypertensive pediatric subjects |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Signed informed consent by a person or a legal guardian. Age 1 to less than 6 years Weight 8805; 10 Kg and 8804; 40 Kg SISBP and/or SIDBP 8805;95 percentile e 8804; 20 mmHg systolic and/or 10 mmHg diastolic above the 95 percentile at screening and at randomization in based on height- adjusted charts for age and gender |
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E.4 | Principal exclusion criteria |
Any situation, clinical condition or laboratory abnormality Weight 8805; 10 Kg and 8804; 40 Kg Less than 80 compliance with study medication during single-blind placeboscreening Hypertension secondary to pheochromocytoma, hyperthyroidism, or Cushing ssyndrome Uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateralrenal artery stenosis in a single kidney Estimated glomerular filtration rate GFR 50 mL/min/1.73m2 based on theSchwartz Formula Renal transplant 6 months prior to study entry Nephrotic syndrome not in remission Unstable insulin dependent diabetes mellitus Known bleeding, coagulation, or platelet disorder that could interfere with bloodsampling Clinically significant valvular heart disease Clinical diagnosis of heart failure Clinically significant arrhythmia Second or third degree AV block Impaired liver function Known hypersensitivity to ARBs Currently receiving an angiotensin receptor blocker or an angiotensin convertingenzyme inhibitor that in the investigator s judgement cannot safely be withdrawnduring the study Currently using, or used within 14 days prior to receiving double-blind medication,any concomitant medications which in the opinion of the investigator couldnegatively affect the subject Unable or unwilling to comply with the study requirements Received an investigational agent within 30 days prior to receiving study medicatio |
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E.5 End points |
E.5.1 | Primary end point(s) |
the slope of linear regression for the change in trough SiSBP from baseline Day 0 to the end of the 4-week double-blind treatment period Day 28 as a function of dose for subjects 1 to less than 6 years of age with hypertension based on the ITT population |
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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 | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |