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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00244621 |
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.
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: candesartan cilexetil (Atacand) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Dose-Ranging Safety and Pharmacokinetics Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects 1 to Less That 6 Years of Age: A 4-Week, Multicenter, Randomized, Double-Blind Study With a 1-Year, Open-Label, Follow-up Period. |
Enrollment: | 95 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
0.05 mg/kg Atacand oral liquid dose
|
Drug: candesartan cilexetil (Atacand)
0.05 mg/kg once daily oral liquid dose
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2: Experimental
0.20 mg /kg Atacand oral liquid dose
|
Drug: candesartan cilexetil (Atacand)
0.20 mg/kg once daily oral liquid dose
|
3: Experimental
0.40 mg /kg Atacand oral liquid dose
|
Drug: candesartan cilexetil (Atacand)
0.40 mg/kg once daily oral liquid dose
|
Ages Eligible for Study: | 1 Year to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Nephrotic syndrome not in remission.
Study Director: | AstraZeneca Atacand Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | D2451C00002, 328 |
Study First Received: | October 25, 2005 |
Last Updated: | September 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00244621 |
Health Authority: | United States: Food and Drug Administration |
Pediatric hypertension |
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 |