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| ID | Type | Description | Link |
|---|---|---|---|
| 261B |
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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 characteristics and antihypertensive efficacy, and between antihypertensive therapy (candesartan cilexetil dose and add-on treatments) and efficacy over a 1 year treatment period in hypertensive children ages 6 to < 17 years; to describe growth in terms of height and weight in the study population; to describe change in neurocognition as assessed by the Full Scaled IQ score in a subset of study subjects; to determine the pharmacokinetics of candesartan in hypertensive paediatric subjects ages 6 to < 17 years; and to describe safety including adverse events and adverse events necessitating study drug discontinuation including dose level and dose duration relationships and growth over a 1 year period in hypertensive children age 6 to < 17 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| candsartan cilexetil | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| - Achieved sitting, trough, systolic blood pressure summarized over time and at Week 52 & the mean of the last two measures. | ||
| - The measure of effect is the mean value and the corresponding descriptive statistics. | ||
| - Additional measures include mean diastolic blood pressure, and the proportion of subjects meeting 'controlled' criteria. |
| Measure | Description | Time Frame |
|---|---|---|
| - Subject and baseline characteristics, antecedent treatment (eg, in 261A, an double-blind placebo-controlled efficacy study that is described elsewhere) | ||
| - The relationship to efficacy measures |
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Inclusion Criteria:
Exclusion Criteria:
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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 | Phoenix | Arizona | United States | |||
| Research Site |
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| - The relationship of antihypertensive treatment (candesartan cilexetil dose; add on therapy) and achieved blood pressure. |
| Beverly Hills |
| California |
| United States |
| Research Site | Los Angeles | California | United States |
| Research Site | Madera | California | United States |
| Research Site | Yuba City | California | United States |
| Research Site | Newark | Delaware | United States |
| Research Site | Wilmington | Delaware | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Athens | Georgia | United States |
| Research Site | Augusta | Georgia | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Park Ridge | Illinois | United States |
| Research Site | Louisville | Kentucky | United States |
| Research Site | Ann Arbor | Michigan | United States |
| Research Site | Jackson | Mississippi | United States |
| Research Site | Port Gibson | Mississippi | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | Paterson | New Jersey | United States |
| Research Site | Brooklyn | New York | United States |
| Research Site | New Hyde Park | New York | United States |
| Research Site | The Bronx | New York | United States |
| Research Site | Charlotte | North Carolina | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Cleveland | Ohio | United States |
| Research Site | Columbus | Ohio | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Pittsburgh | Pennsylvania | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Site | Beaumont | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Salt Lake City | Utah | United States |
| Research Site | Charlottesville | Virginia | United States |
| Research Site | Norfolk | Virginia | United States |
| Research Site | Charleston | West Virginia | United States |
| Research Site | Ghent | Belgium |
| Research Site | Budapest | Hungary |
| Research Site | Miskolc | Hungary |
| Research Site | Szeged | Hungary |
| Research Site | Bratislava | Slovakia |
| Research Site | Martin | Slovakia |
| Research Site | Trnava | Slovakia |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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