Clinical Trial Results:
Efficacy and safety of 3 doses of S 38093 (2, 5 and 20 mg/day) versus placebo in patients with mild to moderate Alzheimer’s disease. A 24-week international, multi-centre, randomised, double-blind, placebo-controlled phase IIb study followed by a 24-week extension period.

Due to a system error, the data reported in v1 is not correct and has been removed from public view.

Summary
EudraCT number	2010-024626-37
Trial protocol	DE CZ PT HU BG
Global end of trial date	21 Mar 2014

Results information
Results version number	v2(current)
This version publication date	22 Jul 2016
First version publication date	31 Jul 2015
Other versions	v1 (removed from public view)
Version creation reason	Correction of full data set Data correction due to a system error in EudraCT – Results

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CL2-38093-011

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Institut de Recherches Internationales Servier (I.R.I.S.)

Sponsor organisation address

50 rue Carnot, Suresnes, France, 92284

Public contact

Therapeutic Innovation Pole, Institut de Recherches Internationales Servier, +33 1 55 72 43 66, clinicaltrials@servier.com

Scientific contact

Therapeutic Innovation Pole, Institut de Recherches Internationales Servier, +33 1 55 72 43 66, clinicaltrials@servier.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

17 Sep 2013

Is this the analysis of the primary completion data?

Yes

Primary completion date

17 Sep 2013

Global end of trial reached?

Yes

Global end of trial date

21 Mar 2014

Was the trial ended prematurely?

Main objective of the trial

The purpose of this trial was to assess the efficacy and safety of S 38093 versus placebo in patients with mild to moderate Alzheimer’s disease (AD).

Protection of trial subjects

Reasons could lead to premature discontinuation of treatment: - Adverse event: any medical reason or circumstance justifying the discontinuation of the treatment in the investigator’s opinion. The patient was to be withdrawn from the study in case of a repeated demonstration of a QTcF > 500 ms or a delta > 60 ms over baseline (inclusion) value. The following changes in hepatic enzymes should led to treatment discontinuation of a study participant: ALAT or ASAT > 8x ULN. ALAT or ASAT > 5x ULN for more than 2 weeks. ALAT or ASAT > 3x ULN and total bilirubin > 2x ULN. ALAT or ASAT > 3x ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (>5%). - Protocol deviation: in case of a missing informed consent or if there was any deviation that could compromise the patient’s safety. - Lack of efficacy (in the investigator’s opinion). - Non medical reason (e.g. patient’s consent withdrawal). - Lost to follow-up: when the investigator had no news from the patient, s/he had to make every effort to contact him/her, to establish if the study treatment had been discontinued, obtain information on the reason for the treatment discontinuation, and to suggest the patient to come to an end-of-study visit. If all attempts to contact the participant failed, the investigator could then declare the participant “lost to follow-up”. The investigator had to document all attempts in the corresponding medical file.

Background therapy

Evidence for comparator

Actual start date of recruitment

18 Oct 2011

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country