Clinical Trial Results:
An Open-label Extension Study of Candesartan Cilexetil in Hypertensive
Pediatric Subjects Ages 1 to <11 Years: A Long-term Study
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Summary
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EudraCT number |
2007-001545-17 |
Trial protocol |
DE BE FR PL IT |
Global end of trial date |
09 Sep 2009
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Apr 2016
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First version publication date |
16 Apr 2016
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
D2451C00006
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00690612 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
AstraZeneca
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Sponsor organisation address |
Pepparedsleden 1, Molndal, Sweden, 431 83
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Public contact |
Robin Mukherjee, R&D/GMD/Biometrics & Information Sciences, robin.mukherjee@astrazeneca.com
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Scientific contact |
Robin Mukherjee, R&D/GMD/Biometrics & Information Sciences, robin.mukherjee@astrazeneca.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
09 Sep 2009
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 Sep 2009
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Global end of trial reached? |
Yes
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Global end of trial date |
09 Sep 2009
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study was to describe the long-term clinical experience of
candesartan cilexetil in hypertensive children ages 1 to <11 years who had participated in
Protocol 328 (D2451C00002) without discontinuation due to a study drug-related AE, and
who had an ongoing clinical indication for treatment with candesartan cilexetil.
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Protection of trial subjects |
The study ICI and the AstraZeneca Study Physician reviewed and discussed each SAE. In
addition, an independent pediatric hypertension expert not otherwise participating in the study
reviewed all SAEs, AEs, and AEs leading to discontinuation (DAEs) of the study drug. The
safety committee consisting of the ICI and the independent expert met 3 times; minutes from
the meetings are archived with the sponsor.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
17 Sep 2007
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 6
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Country: Number of subjects enrolled |
Denmark: 6
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Country: Number of subjects enrolled |
France: 6
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Country: Number of subjects enrolled |
Italy: 6
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Country: Number of subjects enrolled |
Poland: 6
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Country: Number of subjects enrolled |
Ukraine: 5
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Worldwide total number of subjects |
35
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EEA total number of subjects |
30
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
35
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Hypertensive children aged 1 to <11 years who had participated in the 1-year study (Protocol 328, D2451C00002-NCT00244621). First patient enrolled 17 Sep 2007 and last patient completed 9 Sep 2009 at Pediatric clinics in Europe. | ||||||||||||
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Pre-assignment
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Screening details |
Patients who had participated in the 1-year study (Protocol 328, D2451C00002-NCT00244621) and did not discontinue study due to a study drug-related adverse event (AE) and had an ongoing clinical indication for treatment with candesartan. | ||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
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Arms
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Arm title
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Overall | ||||||||||||
Arm description |
Overall | ||||||||||||
Arm type |
Follow-up | ||||||||||||
Investigational medicinal product name |
Candesartan Cilexetil
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
0.05, 0.20 and 0.40 mg
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Baseline characteristics reporting groups
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Reporting group title |
Overall Study
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Overall
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Reporting group description |
Overall | ||
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End point title |
Mean change from baseline to final visit in systolic blood pressure (SBP). [1] | ||||||||
End point description |
Blood pressure response was defined as Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) less than the 95th percentile based on population height-adjusted charts for age and gender. Response rates were based on the proportion of patients meeting the criteria at each evaluation time point or the last available measure.
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End point type |
Primary
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End point timeframe |
Every 3 months- baseline to final visit
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses in the sense of hypothesis testing were carried out for the primary endpoints. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change from baseline to final visit in diastolic blood pressure (DBP). [2] | ||||||||
End point description |
Blood pressure response was defined as Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) less than the 95th percentile based on population height-adjusted charts for age and gender. Response rates were based on the proportion of patients meeting the criteria at each evaluation time point or the last available measure.
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End point type |
Primary
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End point timeframe |
every 3 months - baseline to final visit
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses in the sense of hypothesis testing were carried out for the primary endpoint. |
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
During the entire study period; from 14 days before patient received study medication to end of study (month 27).
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
NA
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Reporting groups
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Reporting group title |
Atacand candesartan cilexetil
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Reporting group description |
candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 2% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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24 Jul 2007 |
Echocardiography (ECHO) is added following recommendation from the Paedeatric Committee (PDCO) at the European Medicines Agency’s (EMEA). |
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11 Feb 2008 |
The investigator or designated cardiologist will perform an echocardiogram (ECHO) at study entry and then annually during the course of this study. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
