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| ID | Type | Description | Link |
|---|---|---|---|
| 328 |
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This is a dose ranging study of candesartan cilexetil in hypertensive pediatric subjects ages 1 to less than 6 years of age. It employs a double blind, randomized, dose ranging design intended for conduct as a multicenter trial. There are 3 study 'periods': a 1-week placebo run-in, a 4-week double blind treatment, and a 52-week open-label, long-term treatment period. Subjects undergo a screening evaluation, then a 1-week single-blind, placebo run-in, after which eligible subjects are allocated to receive 1 of 3 dose levels of candesartan cilexetil (0.05 mg/kg, or 0.20 mg /kg or 0.40 mg /kg), liquid formulation, in a 1:1:1 ratio for 4-weeks. At the end of randomized dose allocation (Day 28), blood pressure assessment will be performed and subjects may begin the 52-week, open-label treatment period of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 0.05 mg/kg Atacand oral liquid dose |
|
| 2 | Experimental | 0.20 mg /kg Atacand oral liquid dose |
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| 3 | Experimental | 0.40 mg /kg Atacand oral liquid dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| candesartan cilexetil (Atacand) | Drug | 0.05 mg/kg once daily oral liquid dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Week 4 in Systolic Blood Pressure (SBP) | From randomisation to end of double-blind treatment (4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP) | From randomisation to end of double-blind treatment (4 weeks) | |
| Change in Albumin/Creatinine (A/C) Ratio for Each Assigned Dose Level From Baseline to Day 28 | From randomisation to day 28 |
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Inclusion Criteria:
Exclusion Criteria:
Nephrotic syndrome not in remission.
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Atacand Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20160654 | Derived | 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. |
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One to 2 weeks following a screening evaluation, participants underwent a 1-week, single-blind, placebo run-in period to reduce the variability in the baseline blood pressure measurements and to stabilize any concurrent antihypertensive medications.
The study population included male and female participants 1 to <6 years of age with mild to moderate hypertension. The participants were recruited during the time period from 04 November 2004 to 07 August 2008 at pediatric clinics in the USA, Puerto Rico and Europe.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atacand .05 mg | candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose |
| FG001 | Atacand .20 mg | candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind Treatment Period |
|
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| candesartan cilexetil (Atacand) | Drug | 0.20 mg/kg once daily oral liquid dose |
|
|
| candesartan cilexetil (Atacand) | Drug | 0.40 mg/kg once daily oral liquid dose |
|
|
| Change in Protein/Creatinine (P/C) Ratio for Each Assigned Dose Level From Baseline to Day 28 | From randomisation to day 28 |
| 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 | Padova | 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 |
| FG002 | Atacand .40 mg | candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose |
| COMPLETED |
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| NOT COMPLETED |
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| Open-label Treatment Period |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atacand .05 mg | candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose |
| BG001 | Atacand .20 mg | candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose |
| BG002 | Atacand .40 mg | candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline to Week 4 in Systolic Blood Pressure (SBP) | Posted | Mean | Standard Deviation | mm Hg | From randomisation to end of double-blind treatment (4 weeks) |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP) | Posted | Mean | Standard Deviation | mm Hg | From randomisation to end of double-blind treatment (4 weeks) |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in Albumin/Creatinine (A/C) Ratio for Each Assigned Dose Level From Baseline to Day 28 | Posted | Median | Inter-Quartile Range | Percent change | From randomisation to day 28 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in Protein/Creatinine (P/C) Ratio for Each Assigned Dose Level From Baseline to Day 28 | Posted | Median | Inter-Quartile Range | Percent change | From randomisation to day 28 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atacand .05 mg | candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose | 6 | 0 | 29 | |||
| EG001 | Atacand .20 mg | candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose | 5 | 0 | 32 | |||
| EG002 | Atacand .40 mg | candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose | 4 | 0 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Catheter Site Haematoma | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Catheter Site Necrosis | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Pyrexia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Drug Hypersensitivity | Immune system disorders | MedDRA 11.0 | Systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| External Ear Cellulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Pneumonia Parainfluenzae Viral | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Glomerulonephritis Chronic | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nephrotic Syndrome | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vena Cava Thrombosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C077793 | candesartan cilexetil |
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| Adverse Event |
|
| Moved abroad |
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| 2 to <6 years |
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| Male |
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