Hypertension in children in ages 1 to <11 years
Conditions
Interventions
Product Name: candesartan cilexetil
Pharmaceutical Form: Oral suspension
INN or Proposed INN: candesartan cilexetil
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concent
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: N/A;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. | — |
Countries
France, Germany, Italy
Outcome results
None listed