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: Hypertension in pediatric subjects 10020772; MedDRA version: 8.1Level: PTClassification code 10020772Term: Hypertension

• Registration Number: EUCTR2004-004264-75-IT
• Lead Sponsor: ASTRAZENECA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-28
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified