Clinical Trial Results:
Patient pREference and satisFaction for pErindopril oRodispersible vs convENtional tablets in daily Clinical practicE.
PREFERENCE
Summary
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EudraCT number |
2011-003328-11 |
Trial protocol |
FR |
Global end of trial date |
28 Apr 2014
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Results information
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Results version number |
v1 |
This version publication date |
26 Nov 2016
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First version publication date |
26 Nov 2016
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Other versions |
v2 |
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 |
DM4-90652-001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Institut de Recherches Internationales Servier
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Sponsor organisation address |
50 rue Carnot, Suresnes, France,
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Public contact |
Clinical Studies Department, Institut de Recherches Internationales Servier, 33 01 55 72 43 66, clinicaltrials@servier.com
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Scientific contact |
Clinical Studies Department, Institut de Recherches Internationales Servier, 33 01 55 72 43 66, clinicaltrials@servier.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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Apr 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Apr 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Apr 2014
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To study, in hypertensive patients, followed in general practice and whose Blood Pressure is well controlled by a monotherapy with tablets of perindopril arginine, their preference and acceptability in favour of the orodispersible form of this medicinal product 1 month after changing the dosage form.
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Protection of trial subjects |
This study was conducted in accordance with Good Clinical Practice standards, ethical principles stated in the Declaration of Helsinki and applicable regulatory requirements. After the subject has ended his/her participation in the trial, the investigator provided appropriate medication and/or arranged access to appropriate care for the patient.
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Background therapy |
Before entry in the study patients were treated by their doctor with perindopril arginine 5 or 10 mg per day administered as tablet, and at the same dose for at least 3 months | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
22 Feb 2013
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Efficacy | ||
Long term follow-up duration |
3 Months | ||
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 |
France: 12
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Worldwide total number of subjects |
12
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EEA total number of subjects |
12
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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) |
8
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From 65 to 84 years |
4
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85 years and over |
0
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Recruitment
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Recruitment details |
• Adult male or female, without upper limit for the age, with arterial hypertension (systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mmHg) previously treated with perindopril arginine as tablet, 5 or 10 mg per day, and at stable dose for at least 3 months | ||||||
Pre-assignment
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Screening details |
- | ||||||
Pre-assignment period milestones
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Number of subjects started |
12 | ||||||
Number of subjects completed |
12 | ||||||
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 | ||||||
Arms
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Arm title
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Perindopril arginine orodispersible | ||||||
Arm description |
an orodispersible tablet of perindopril arginine at posology of 5 or 10 mg per day over a maximum period of 3 months. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Perindopril arginine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Orodispersible tablet
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Routes of administration |
Oral use
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Dosage and administration details |
5 or 10 mg/day
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Baseline characteristics reporting groups
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Reporting group title |
Perindopril arginine orodispersible
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Reporting group description |
an orodispersible tablet of perindopril arginine at posology of 5 or 10 mg per day over a maximum period of 3 months. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Perindopril arginine orodispersible
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Reporting group description |
an orodispersible tablet of perindopril arginine at posology of 5 or 10 mg per day over a maximum period of 3 months. |
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End point title |
Preference for orodispersible versus tablet perindopril arginine form at one month [1] | ||||||
End point description |
5 questions were included in the questionnaire that was filled in after one month after patient's inclusion
- Question 1 : Preference for orodispersible form (versus tablet) ?
- Question 2: Is orodispersible form the most convenient ?
- Question 3 : Is orodispersible form the most appropriate ?
- Question 4: Would you use orodispersible form for a long treatment period ?
- Question 5 : Would you use orodispersible form for the further 2 months ?
As no statistical analysis of the questionnaire was conducted due to the low number of patients included in the study, the endpoint described hereafter correspond to the answer to the question 1. Of note the same score was obtained for question 2, 3, 4, and at question 5 all patients responded that they would use for further 2 months the orodispersible perindopril arginine form.
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End point type |
Primary
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End point timeframe |
Over 30 days
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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: A low number of patients could be included in the study (n = 12) compared to the number planned (n = 100), due to difficulty to recruit patients that led to premature study discontinuation. Therefore it had been decided to not carry out statistical analysis of the questionnaires. |
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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 |
Overall study
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
14.1
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Reporting groups
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Reporting group title |
Perindopril arginine orodispersible
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Reporting group description |
- | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
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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: This study was conducted in very few patients, followed by their doctor, for whom the arterial hypertension was well controlled with perindopril arginine 5 or 10 mg per day administered as tablet for at least 3 months. In the Preference study patients switched from this background therapy to the same product same dose but with an orodispersible form, on a short duration. None of the patients reported as medical history co-morbidities. It is probably why no non-serious adverse event occurred. |
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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? Yes | |||||||
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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 |