Status:
COMPLETED
Efficacy, Safety, & Pharmacokinetics of Candesartan Cilexetil in Hypertensive Paediatric Subjects 6 to < 17 Years of Age
Lead Sponsor:
AstraZeneca
Conditions:
Hypertension
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
The objectives of this study are to describe candesartan cilexetil antihypertensive effects in terms of achieved blood pressure and hypertension control rates and the relationship between subject char...
Eligibility Criteria
Inclusion
- The subjects must have fulfilled the eligibility criteria for and have participated in Study 261A or did not participate in Study 261A but meet the following criteria:
- Diagnosed and untreated hypertension, or
- Diagnosed and treated, but off antihypertensive treatment for at least 2 days with a mean sitting systolic blood pressure and/or sitting diastolic blood pressure ≥ 95th percentile and ≤ 20 mm Hg (systolic) and/or 10 (diastolic) mm Hg above the 95th percentile based on height-adjusted charts for age and gender.
- Females of childbearing potential (post-menarche), must have a negative urine pregnancy test and adhere to a pregnancy prevention method (abstinence, a barrier method plus a spermicidal foam or an 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 (except in Study 261A).
- Alcohol or drug abuse.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT00244595
Start Date
September 1 2003
End Date
November 1 2006
Last Update
December 9 2009
Active Locations (44)
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1
Research Site
Phoenix, Arizona, United States
2
Research Site
Beverly Hills, California, United States
3
Research Site
Los Angeles, California, United States
4
Research Site
Madera, California, United States