Status:
COMPLETED
Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of Age
Lead Sponsor:
AstraZeneca
Conditions:
Pediatric Hypertension
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
Study 261A is a dose-ranging and safety study of candesartan cilexetil. It is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with a 4 week treatment p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT00244634
Start Date
September 1 2003
End Date
November 1 2005
Last Update
December 19 2007
Active Locations (44)
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1
Research Site
Beverly Hills, California, United States
2
Research Site
Los Angeles, California, United States
3
Research Site
Madera, California, United States
4
Research Site
Yuba City, California, United States