EUCTR2004-004264-75-ITActive, not recruitingNot Applicable
A dose ranging, safety and pharmacokinetics study of Candesartan Cilexetil in hypertensive pediatric subjects 1 to less than 6 years of age a 4-week, multicenter, randomised, double blind study with a 1 year open-label, follow-up period - ND
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ASTRAZENECA
- Enrollment
- 125
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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
Investigators
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