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| Sponsor: | AstraZeneca |
|---|---|
| Information provided by: | 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 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 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
0.05 mg/kg Atacand oral liquid dose
|
Drug: candesartan cilexetil (Atacand)
0.05 mg/kg once daily oral liquid dose
|
|
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
|
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
Hide Study Locations| United States, Alabama | |
| Research Site | |
| Birmingham, Alabama, United States | |
| United States, Arkansas | |
| Research Site | |
| Little Rock, Arkansas, United States | |
| United States, California | |
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| Los Angeles, California, United States | |
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| San Francisco, California, United States | |
| United States, Florida | |
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| Miami, Florida, United States | |
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| Orlando, Florida, United States | |
| United States, Idaho | |
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| Boise, Idaho, United States | |
| United States, Michigan | |
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| Detroit, Michigan, United States | |
| United States, North Carolina | |
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| Durham, North Carolina, United States | |
| United States, Ohio | |
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| Cleveland, Ohio, United States | |
| United States, Oregon | |
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| Portland, Oregon, United States | |
| United States, Pennsylvania | |
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| Malvern, Pennsylvania, United States | |
| United States, Tennessee | |
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| Chattanooga, Tennessee, United States | |
| United States, Texas | |
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| Beaumont, Texas, United States | |
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| Houston, Texas, United States | |
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| San Antonio, Texas, United States | |
| Belgium | |
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| Edegem, Belgium | |
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| Gent, Belgium | |
| Denmark | |
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| Arhus, Denmark | |
| France | |
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| STRASBOURG CEDEX, France | |
| Germany | |
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| Berlin, Germany | |
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| ERLANGEN, Germany | |
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| Hamburg, Germany | |
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| Heidelberg, Germany | |
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| Marburg, Germany | |
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| ROSTOCK, Germany | |
| Italy | |
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| GENOVA, Italy | |
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| MILANO, Italy | |
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| PADOVA, Italy | |
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| ROMA, Italy | |
| Poland | |
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| GDANSK, Poland | |
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| KRAKÓW, Poland | |
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| WARSZAWA, Poland | |
| Puerto Rico | |
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| San Juan, Puerto Rico | |
| Ukraine | |
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| CRIMEA, Ukraine | |
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| KYIV, Ukraine | |
| United Kingdom | |
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| LONDON, United Kingdom | |
| Research Site | |
| MANCHESTER, United Kingdom | |
| Study Director: | AstraZeneca Atacand Medical Science Director, MD | AstraZeneca |
More Information
| Study ID Numbers: | D2451C00002, 328 |
| Study First Received: | October 25, 2005 |
| Results First Received: | August 7, 2009 |
| Last Updated: | August 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00244621 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Pediatric hypertension |
|
Angiotensin II Type 1 Receptor Blockers Candesartan cilexetil Molecular Mechanisms of Pharmacological Action Therapeutic Uses Candesartan Vascular Diseases |
Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Hypertension |