Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 years of age

Study identifier:D2451C00261

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Dose-Ranging and Safety Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects 6 to <17 Years of Age: A 4-Week, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study

Medical condition

Pediatric hypertension

Phase

Phase 3

Healthy volunteers

Study drug

candsartan cilexetil

Sex

All

Actual Enrollment

238

Study type

Interventional

Age

6 Years - 17 Years

Date

Study Start Date: 01 Sept 2003

Primary Completion Date: -

Study Completion Date: 01 Nov 2005

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Male or female ages 6 to < 17 years-of-age after parent or guardian’s signing of informed consent.
Subjects with hypertension that is either:
- Diagnosed and untreated with a mean sitting systolic and/or diastolic blood pressure ≥ 95th percentile and ≤ 20 mm Hg (systolic) and/or 10 mm Hg (diastolic) above the 95th percentile at randomisation based on height-adjusted charts for age and gender; or
- Previously diagnosed and currently treated with mean sitting systolic blood pressure and/or diastolic blood pressure ≥ 95th percentile and ≤ 20 mm Hg (systolic) and/or 10 mm Hg (diastolic) above the 95th percentile at randomisation (off treatment) based on height-adjusted charts for age and gender.
Females of childbearing potential (post-menarche) must have a negative urine pregnancy test prior to randomization and adhere to a pregnancy prevention method (abstinence, barrier method plus spermicidal foam, oral, or implanted contraceptive).
A signed informed consent by a parent or a legal guardian and an assent form signed by the subject (if applicable).

Exclusion Criteria

- 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.
- Hypertension secondary to coarctation of the aorta, pheochromocytoma, hyperthyroidism, Cushing’s syndrome, or medications (eg: corticosteroids).
- Known history of bilateral renal artery stenosis, unilateral renal artery stenosis or a renal transplant.
- Glomerular filtration rate < 50 mL/min based on an estimated value using the Schwartz Formula.
- Nephrotic syndrome not in remission.
- Insulin dependent diabetes mellitus.
- Known bleeding, coagulation, or platelet disorder that could interfere with blood sampling.
- Clinically significant valvular heart disease.
- Clinical diagnosis of heart failure.
- Clinically significant arrhythmia (eg, any arrhythmia requiring medical therapy or that causes symptoms).
- Second or third degree AV block.
- Pregnant or breast-feeding an infant.
- 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 AST or ALT.
- Known hypersensitivity to ARBs.
- Unable to be off antihypertensive medication (diuretics, beta blockers, ACE Inhibitors, etc) for 6-weeks.
- Inability to discontinue medications which may contribute to elevated blood pressure e.g. systemic corticosteroids.
- 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.
- Unable or unwilling to comply with the study requirements including blood sampling and swallowing study drug tablets.
- Received an investigational agent within 30 days prior to receiving study medication.
- Alcohol or drug abuse.

No locations available

Arms	Assigned Interventions

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1265&filename=CSR-D2451C00261.pdf
Download
CSR-D2451C00261.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Information Center

800-236-9933, (US - 8a-7p EST)

Investigators

Principal Investigator

AstraZeneca Atacand Medical Science Director

AstraZeneca