Atacand Dose Ranging in Hypertensive Pediatric Subjects 1 Year to Less Than 6 Years of Age
NCT ID: NCT00244621
Last Updated: 2011-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
95 participants
INTERVENTIONAL
2004-11-30
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
0.05 mg/kg Atacand oral liquid dose
candesartan cilexetil (Atacand)
0.05 mg/kg once daily oral liquid dose
2
0.20 mg /kg Atacand oral liquid dose
candesartan cilexetil (Atacand)
0.20 mg/kg once daily oral liquid dose
3
0.40 mg /kg Atacand oral liquid dose
candesartan cilexetil (Atacand)
0.40 mg/kg once daily oral liquid dose
Interventions
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candesartan cilexetil (Atacand)
0.05 mg/kg once daily oral liquid dose
candesartan cilexetil (Atacand)
0.20 mg/kg once daily oral liquid dose
candesartan cilexetil (Atacand)
0.40 mg/kg once daily oral liquid dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Weight \> 10 kg and \< 40 kg.
* SiSBP and/or SiDBP \> 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.
Exclusion Criteria
* Weight \< 10 kg and \> 40 kg.
* Less than 80% compliance with study medication during single-blind placebo screening as assessed by residual medication volume.
* Hypertension secondary to pheochromocytoma, hyperthyroidism, or Cushing's Syndrome.
* Uncorrected coarctation of the aorta, bilateral renal artery renal artery stenosis in a single kidney.
* Estimated glomerular filtration rate (GFR) \< 50 mL/min/1.73m 2 based on the Schwartz Formula (Schwartz et al, 1987).
* Renal transplant \< 6 months prior to study entry. Subjects who have received a renal transplant \> 6 months prior to study entry may participate in the study if: 1) renal function is stable, 2) estimated GFR \>50 mL/min/1.73m 2, 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.
Nephrotic syndrome not in remission.
* Unstable 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.
* 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).
* Known hypersensitivity to ARBs.
* Currently receiving an angiotensin receptor blocker or an angiotensin converting enzyme inhibitor that in the investigator's judgment cannot safely be withdrawn during 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 could negatively affect the subject.
* Unable or unwilling to comply with the study requirements including blood sampling and swallowing study drug suspension.
1 Year
6 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca Atacand Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Los Angeles, California, United States
Research Site
San Francisco, California, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Boise, Idaho, United States
Research Site
Detroit, Michigan, United States
Research Site
Durham, North Carolina, United States
Research Site
Cleveland, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Malvern, Pennsylvania, United States
Research Site
Chattanooga, Tennessee, United States
Research Site
Beaumont, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Edegem, , Belgium
Research Site
Ghent, , Belgium
Research Site
Aarhus, , Denmark
Research Site
Strasbourg, , France
Research Site
Berlin, , Germany
Research Site
Erlangen, , Germany
Research Site
Hamburg, , Germany
Research Site
Heidelberg, , Germany
Research Site
Marburg, , Germany
Research Site
Rostock, , Germany
Research Site
Genova, , Italy
Research Site
Milan, , Italy
Research Site
Padua, , Italy
Research Site
Roma, , Italy
Research Site
Gdansk, , Poland
Research Site
Krakow, , Poland
Research Site
Warsaw, , Poland
Research Site
San Juan, , Puerto Rico
Research Site
Crimea, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
London, , United Kingdom
Research Site
Manchester, , United Kingdom
Countries
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References
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Schaefer F, van de Walle J, Zurowska A, Gimpel C, van Hoeck K, Drozdz D, Montini G, Bagdasorova IV, Sorof J, Sugg J, Teng R, Hainer JW; Candesartan in Children with Hypertension Investigators. Efficacy, safety and pharmacokinetics of candesartan cilexetil in hypertensive children from 1 to less than 6 years of age. J Hypertens. 2010 May;28(5):1083-90. doi: 10.1097/HJH.0b013e328336b86b.
Other Identifiers
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328
Identifier Type: -
Identifier Source: secondary_id
D2451C00002
Identifier Type: -
Identifier Source: org_study_id