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| Sponsor: | AstraZeneca |
|---|---|
| Information provided by (Responsible Party): | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00244621 |
Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
0.05 mg/kg Atacand oral liquid dose
|
Drug: candesartan cilexetil (Atacand)
0.05 mg/kg once daily oral liquid dose
Other Name: Atacand
|
|
Experimental: 2
0.20 mg /kg Atacand oral liquid dose
|
Drug: candesartan cilexetil (Atacand)
0.20 mg/kg once daily oral liquid dose
Other Name: ATACAND
|
|
Experimental: 3
0.40 mg /kg Atacand oral liquid dose
|
Drug: candesartan cilexetil (Atacand)
0.40 mg/kg once daily oral liquid dose
Other Name: ATACAND
|
Eligibility| 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.
Contacts and Locations
Show 38 Study Locations| Study Director: | AstraZeneca Atacand Medical Science Director, MD | AstraZeneca |
More Information
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00244621 History of Changes |
| Other Study ID Numbers: | D2451C00002, 328 |
| Study First Received: | October 25, 2005 |
| Results First Received: | August 7, 2009 |
| Last Updated: | August 29, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Pediatric hypertension |
|
Hypertension Vascular Diseases Cardiovascular Diseases Candesartan cilexetil Candesartan Angiotensin II Type 1 Receptor Blockers |
Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |