Clinical Trial Results:
Gastrointestinal behavior of simvastatin in healthy volunteers
Summary
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EudraCT number |
2013-001715-76 |
Trial protocol |
BE |
Global end of trial date |
16 Oct 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
23 May 2020
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First version publication date |
23 May 2020
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Other versions |
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Summary report(s) |
Geboers- simvastatin |
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 |
FTB13-SMV01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Clinical Trail Center: s55581 | ||
Sponsors
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Sponsor organisation name |
KU Leuven
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Sponsor organisation address |
Herestraat 49, Leuven, Belgium, 3000
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Public contact |
Drug Delivery and Disposition, KU Leuven, 32 16330301, sophie.geboers@pharm.kuleuven.be
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Scientific contact |
Drug Delivery and Disposition, KU Leuven, 32 16330301, sophie.geboers@pharm.kuleuven.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 |
01 Apr 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Apr 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Oct 2014
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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 |
To evaluate the gastrointestinal behavior and absorption of simvastatin.
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Protection of trial subjects |
No specific measures were taken to protect the trial subjects.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Mar 2013
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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: 5
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Worldwide total number of subjects |
5
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EEA total number of subjects |
5
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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) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
5
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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 |
- | ||||||
Pre-assignment
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Screening details |
NA | ||||||
Period 1
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Period 1 title |
water condition (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
NA
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Arms
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Arm title
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Fasted state conditions | ||||||
Arm description |
administering simvastatine in fasted state conditions | ||||||
Arm type |
Placebo | ||||||
Investigational medicinal product name |
Simvastatin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
A single tablet of Zocor (simvastatin, 40 mg) was administered together with 250 mL of water.
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Baseline characteristics reporting groups
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Reporting group title |
Fasted state conditions
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Reporting group description |
administering simvastatine in fasted state conditions | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
subject analysis set
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
descriptive statistics (mean+ SD)
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End points reporting groups
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Reporting group title |
Fasted state conditions
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Reporting group description |
administering simvastatine in fasted state conditions | ||
Subject analysis set title |
subject analysis set
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
descriptive statistics (mean+ SD)
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End point title |
GI and plasma AUC, Cmax and Tmax | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
4 hour timeframe
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Statistical analysis title |
Data Presentation and Statistical Analysis | ||||||||||||
Comparison groups |
Fasted state conditions v subject analysis set
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Number of subjects included in analysis |
10
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Analysis specification |
Post-hoc
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
ANOVA | ||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
before and after the study. No AE were reported.
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
Excel file | ||
Dictionary version |
office 365
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Frequency threshold for reporting non-serious adverse events: 0% | |||
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 AE were reported. |
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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. | |||
NA |