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, Randomized, Double-Blind Study with a 1-year Open-label, Follow-up Period.

AstraZeneca Pharmaceuticals0 sites125 target enrollmentStarted: June 14, 2005Last updated: October 27, 2014

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Active, not recruiting
Sponsor
Enrollment: 125

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional clinical trial of medicinal product

Eligibility Criteria

Sex: All

Inclusion Criteria

•For study inclusion, subjects must fulfill all eligibility criteria
•1)Signed informed consent by a parent or a legal guardian
•2)Age 1 to less than 6 years
•3)Weight ³ 10 kg and £ 40 kg
•4)SiSBP and/or SiDBP ³ 95th percentile and £ 20 mm Hg (systolic) and/or 10 mm Hg (diastolic) above the 95th percentile at screening and at randomization based on height-adjusted charts for age and gender (Appendices C through H)
•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

•The following exclude subjects from study participation:
•1) Any situation, clinical condition or laboratory abnormality that, in the opinion of the investigator or sponsor, may interfere with the subject’s participation in the study or would pose a significant risk to the subject or interfere with the assessment of safety and efficacy endpoints
•2) Weight < 10 kg and > 40 kg
•3) Less than 80% compliance with study medication during single-blind placebo screening as assessed by residual medication volume
•4) Hypertension secondary to pheochromocytoma, hyperthyroidism, or Cushing’s syndrome
•5) Uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateral renal artery stenosis in a single kidney
•6) Estimated glomerular filtration rate (GFR) < 50 mL/min/1.73m2 based on the Schwartz Formula (Schwartz et al, 1987)
•7) Renal transplant < 6 months prior to study entry
•Subjects who have received a renal transplant ³ 6 months prior to study entry may participate in the study if: 1) renal function is stable, 2) estimated GFR >50 mL/min/1.73m2, 3) stable doses of immunosuppressive medications are anticipated throughout the 4-week, double-blind period of the study, 4) no episodes of acute allograft rejection have occurred within 30 days of study entry, and 5) the renal allograft has no documented renal artery stenosis
•8) Nephrotic syndrome not in remission
•9) Unstable insulin dependent diabetes mellitus
•10) Known bleeding, coagulation, or platelet disorder that could interfere with blood sampling
•11) Clinically significant valvular heart disease
•12) Clinical diagnosis of heart failure
•13) Clinically significant arrhythmia (eg, any arrhythmia requiring medical therapy or that causes symptoms)
•14) Second or third degree AV block
•15) Impaired liver function defined as either acute liver disease or chronic liver disease with persistent liver enzyme values greater than 1½ times the upper limit of the reference range for aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
•16) Known hypersensitivity to ARBs
•17) Currently receiving an angiotensin receptor blocker or an angiotensin converting enzyme inhibitor that in the investigator’s judgement cannot safely be withdrawn during the study
•Subjects receiving an angiotensin receptor blocker or an angiotensin converting enzyme inhibitor may be eligible if they undergo withdrawal of the antihypertensive medication over a 2-week washout period and subsequently meet BP inclusion/exclusion criteria.
•Subjects currently receiving other classes of antihypertensive medications (eg, diuretics, calcium channel blockers or beta-blockers) and whose BP values meet inclusion/exclusion criteria may participate in the study while continuing their current antihypertensive medication regimen. Up to 2 concomitant antihypertensive medications are permitted. Doses and dose regimens of concomitant antihypertensive medications must remain unchanged during the 4-week double-blind period of the study.
•18) Currently using, or used within 14 days prior to receiving double-blind medication, any concomitant medications which in the opinion of the investigator could negatively affect the subject
•19) Unable or unwilling to comply with the study requirements including blood sampling and swallowing study drug suspension
•20) Received an investigational agent within 30 days prior to receiving study medication

Investigators

Sponsor

AstraZeneca Pharmaceuticals

Similar Trials

Active, not recruiting

Phase 1

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, Randomized, Double-Blind Study with a 1-year Open-label, Follow-up Period.Hypertension in children under the age of 6 years

EUCTR2004-004264-75-GBAstraZeneca AB93

Active, not recruiting

Not Applicable

EUCTR2004-004264-75-DEAstraZeneca AB125

Active, not recruiting

Not Applicable

EUCTR2004-004264-75-DKAstraZeneca Pharmaceuticals125

Active, not recruiting

Not 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 - NDHypertension in pediatric subjects 10020772MedDRA version: 8.1Level: PTClassification code 10020772Term: Hypertension

EUCTR2004-004264-75-ITASTRAZENECA125

Completed

Phase 1

To know the amount of the drug and safety of Brimonidine Tartarate ophthalmic suspensio

CTRI/2019/03/018023Sun Pharma Advanced Research Company Limited13