E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hypertension in children in ages 1 to <11 years |
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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 |
To describe the long-term clinical experience of candesartan cilexetil in hypertensive children ages 1 to <11 years who have completed Protocol 328 (D2451C00002) and who have an ongoing clinical indication for treatment with candesartan cilexetil. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
For study inclusion, subjects must fulfil all eligibility criteria:
1. Must have participated in Protocol 328 (without discontinuation due to a study drug related AE). If there have been more than 30 days between the last visit for Protocol 328 and the first visit for this study (Protocol D2451C00006), the subject’s participation in the study is subject to sponsor approval.
2. Signed informed consent by a parent or a legal guardian.
3. Have, in the opinion of the investigator, an on-going clinical indication for an oral liquid formulation of candesartan cilexetil. For selected patients i.e. obese patients who have lost weight, appropriate dose reductions must be considered. Subsequent doses of study drug should be calculated based on current weight and must adhere to the dosing guidelines outlines in section 3.4.1.1. A "step-down" therapy in selceted patients (e.g. obese patient after weight reduction) should be considered as an option before inclusion in the study.
4. Age 1 to less than 11 years.
5. Weight ≥ 10 kg and ≤ 40 kg. |
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E.4 | Principal exclusion criteria |
The following exclude subjects from study participation:
1. Any situation, clinical condition (such as clinically significant declining renal function) or laboratory abnormality that, in the opinion of the investigator or sponsor, may interfere with the subject’s participation in the study, pose a significant risk to the subject or interfere with the assessment of the study safety and efficacy measurements.
2. Estimated glomerular filtration rate (GFR) <30 ml/min/1.73m2 for non-transplant patients and <40 ml/min/1.73m2 for transplant patients based on the Schwartz Formula (Schwartz et al 1987) as determined at enrollment into Study 328.
3. Impaired liver function defined as either acute liver disease or chronic liver disease with persistently elevated liver enzyme values judged clinically significant by the investigator.
4. Currently using any medications that, in the opinion of the investigator could negatively affect the subject when given together with candesartan cilexetil.
5. Unable or unwilling to comply with the study requirements including blood sampling and swallowing study drug suspension.
6. Received an investigational agent (other than study medication in Protocol 328) within 30 days prior to receiving study medication.
7. Experienced a candesartan cilexetil related AE while participating in Protocol 328 that necessitated discontinuation of the medication. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Blood pressure response is defined as SBP and DBP less than the 95th percentile based on height-adjusted charts for age and gender. Response rates are based on the proportion of subjects meeting the criteria at each evaluation time point or the last available measure. Ninety-five percent confidence intervals for the response rates are provided. Blood pressures attained at each evaluation time point are summarized by n, mean, standard deviation (SD), minimum, median, and maximum.
Safety evaluations include reported AEs, heart rate, physical examinations, echocardiograms and clinical laboratory test results. The number and percent of subjects with AEs are tabulated for preferred terms by body systems. SAEs and AEs leading to study discontinuation are listed in detail. Heart rate is summarized over time. Echocardiograms and clinical laboratory test results are summarized descriptively. Height/length and weight are also presented descriptively. |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
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) | 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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
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 | 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
|
last subject completed on 31 August 2009 will be considered end of study |
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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 | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |