Clinical Trial Results:
Dose Titration of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension
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Summary
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EudraCT number |
2012-002927-14 |
Trial protocol |
BE |
Global end of trial date |
14 Jun 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Jun 2024
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First version publication date |
07 Jun 2024
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Other versions |
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Summary report(s) |
Final Study Report Protocol |
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 |
AGO/2012/004
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02184858 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
UZ Ghent
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Sponsor organisation address |
Corneel Heymanslaan 10, 9000, Belgium, Ghent
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Public contact |
Hiruz CTU, Ghent University Hospital, 32 93320500, hiruz.ctu@uzgent.be
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Scientific contact |
Hiruz CTU, Ghent University Hospital, 32 93320500, hiruz.ctu@uzgent.be
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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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
16 Dec 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
08 May 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Jun 2018
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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 |
Evaluation of the efficacy and safety of lisinopril in children aged 1 to 18 years with both primary and secondary hypertension.
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Protection of trial subjects |
Ethics review and approval, informed consent, supportive care and routine monitoring.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
27 Aug 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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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: 13
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Worldwide total number of subjects |
13
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EEA total number of subjects |
13
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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) |
6
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Adolescents (12-17 years) |
7
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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 |
13 patients were recruited between 25-JUN-2014 abd 08-May-2017. End of trial notification was dated 14-Jun-2018(last patient last visit) and submitted to EC and CA on17-Sep-2018. There were no dropouts. | |||||||||
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Pre-assignment
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Screening details |
Patients between 1 and 18 years with a systolic and/or diastolic blood pressure above the 95th percentile for their age without rversible cause were included. Patients were screened as per inclusion and exclusion criteria in the protocol. | |||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
Open label trial
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Baseline data | |||||||||
Arm description |
Baseline data of patients inrolled in the trial | |||||||||
Arm type |
Baseline arm | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Active arm | |||||||||
Arm description |
Active arm with lisinopril administration | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Lisinopril
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Start dose of 0.1mg/kg/day with monthly uptitration with 0.1mg/kg/day until a maximal dose of 0.4mg/kg/day.
In case of GFR >30-60ml/min: Start dose of 0.05mg/kg/day with monthly uptitration with 0.05mg/kg/day until a maximal dose of 0.2mg/kg/day.
In case of GFR >30-60ml/min: Start dose of 0.025mg/kg/day with monthly uptitration with 0.025mg/kg/day until a maximal dose of 0.1mg/kg/day.
In case of GFR >30-60ml/min: Start dose of 0.0125mg/kg/day with monthly uptitration with 0.0125mg/kg/day until a maximal dose of 0.05mg/kg/day.
Patients already on lisinopril treated with a study dose closest to their current dose and will start at visit 2, 4 or 6 depending on the start dose.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Baseline data
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Reporting group description |
Baseline data of patients inrolled in the trial | ||
Reporting group title |
Active arm
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Reporting group description |
Active arm with lisinopril administration | ||
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End point title |
Reaching target blood pressure by personalized lisinopril dosing [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Dose is increased to a maximum over the period of 4 weeks or untill hypotension would occur
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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: See attachments |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Dose-response correlation | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
continuous monitoring during the course of the study
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
From start until end of study.
Only SAEs were reported
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Adverse event reporting additional description |
Only SAEs were reported
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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 |
21.1
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Reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
All subjects in the trial | ||||||||||||||||||||||||||||||||||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No non-serious adverse events were recorded for the participating patients |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
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. | |||
| Due to the strict GMP legislation, the magistral preparation of lisinoprii became too labor intensive | |||
