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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00244595 |
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.
Condition | Intervention | Phase |
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Hypertension |
Drug: candsartan cilexetil |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Multicenter, Multinational, Open-Label Study of the Efficacy, Safety, and Pharmacokinetics of Candesartan Cilexetil in Hypertensive Paediatric Subjects 6 to < 17 Years of Age |
Estimated Enrollment: | 235 |
Study Start Date: | September 2003 |
Study Completion Date: | November 2006 |
Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | AstraZeneca Atacand Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | D2451C00001, 261B |
Study First Received: | October 25, 2005 |
Last Updated: | December 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00244595 |
Health Authority: | United States: Food and Drug Administration |
Pediatric hypertension Hypertension in children |
Candesartan cilexetil Candesartan Vascular Diseases Angiotensin II Hypertension |
Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action Therapeutic Uses Cardiovascular Diseases |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |