Performance in Delivering Clinical Trials - Q2 2016-17
Integrated
Research Ethics
Research
Committee
Application
Reference
System
Number
Number
12/LO/0082
12/WS/0300
Reason For
Closure Of
Trial
92190
A MULTI-CENTER, OPEN-LABEL STUDY OF CPNumber
690,550 IN SUBJECTS WITH MODERATE TO
Agreed
SEVERE ULCERATIVE COLITIS
4
4
Date Agreed
31/03/2016
4
31/03/2016
4
Recruitment
Finished
114081
A Randomized, Double-Blind, PlaceboControlled, Parallel-Group Study to Evaluate
the Effect of SAR236553/REGN727 on the
Occurrence of Cardiovascular Events in
Patients Who Have Recently Experienced an
Acute Coronary Syndrome
Number
Agreed
10
10
Date Agreed
31/08/2016
0
02/11/2015
0
Recruitment
Finished
Number
Agreed
5
5
Date Agreed
23/10/2015
9
28/10/2015
9
Recruitment
Finished
Number
Agreed
2
2
Date Agreed
12/11/2015
0
04/11/2015
0
Recruitment
Finished
Range
Agreed
1
2
Date Agreed
15/06/2016
1
03/05/2016
1
Recruitment
Finished
14/EE/0102
149126
15/SC/0239
173072
12/SC/0394
Name of Trial
Total
Date Agreed
Total
Target
Minimum Maximum Target Date
Number Of
Date That
to recruit
Number Of
Number Of Number Of Number Of To Recruit
Patients
The Trial
target
Study
Patients
Patients
Patients
Patients
Recruited At Closed To
number of
Participants
Agreed?
Agreed
Agreed
Agreed?
The Agreed Recruitment
patients
Recruited
Target Date
108188
PROSPECTIVE, RANDOMIZED, OPEN-LABEL,
BLINDED ENDPOINT EVALUATION (PROBE)
PARALLEL GROUP STUDY COMPARING
EDOXABAN (DU-176b) WITH
ENOXAPARIN/WARFARIN FOLLOWED BY
WARFARIN ALONE IN SUBJECTS
UNDERGOING PLANNED ELECTRICAL
CARDIOVERSION OF NONVALVULAR ATRI
A randomized, parallel-group, double-blind,
placebo- and active-controlled, multi-center
study to assess the efficacy and safety of two
regimens of vilaprisan in patients with
uterine fibroids
A Randomized, Open Label Study of
Ofatumumab and Bendamustine
Combination Therapy Compared with
Bendamustine Monotherapy in Indolent Bcell Non-Hodgkin'sLymphoma Unresponsive
to Rituximab or a Rituximab-Containing
Regimen During or Within Six Months
Comments
UK Recruitment Terminated
Early
Page 1 of 2
Performance in Delivering Clinical Trials - Q2 2016-17
Integrated
Research Ethics
Research
Committee
Application
Reference
System
Number
Number
13/EE/0339
15/NE/0270
15/WM/0410
14/LO/1997
Name of Trial
Total
Date Agreed
Total
Target
Minimum Maximum Target Date
Number Of
Date That
to recruit
Number Of
Number Of Number Of Number Of To Recruit
Patients
The Trial
target
Study
Patients
Patients
Patients
Patients
Recruited At Closed To
number of
Participants
Agreed?
Agreed
Agreed
Agreed?
The Agreed Recruitment
patients
Recruited
Target Date
Reason For
Closure Of
Trial
122902
A randomized controlled trial of rivaroxaban
for the prevention of major cardiovascular
events in patients with coronary or peripheral Number
artery disease (COMPASS - Cardiovascular
Agreed
OutcoMes for People using Anticoagulation
StrategieS)
50
50
Date Agreed
31/05/2016
26
09/05/2016
26
Recruitment
Finished
180799
A randomised, double-blind, double-dummy,
parallel-group, multicenter, phase IIb study to
evaluate the effect of ticagrelor 10 mg and 45 Number
mg bid versus placebo in reducing the
Agreed
number of days with pain in young adults
with sickle cell disease
2
2
Date Agreed
30/06/2016
2
30/06/2016
2
Recruitment
Finished
193904
Efficacy and Safety of LEO 43204 in Field
Treatment of Actinic Keratosis on Balding
Scalp including 12-month follow-up
Number
Agreed
12
12
Date Agreed
10/06/2016
6
10/06/2016
6
Recruitment
Finished
167263
Treating Diabetic Lipohypertrophy: Intensive
Education vs Standard Care: A Randomised, Number
Prospective, Controlled Study in Ealing,
Agreed
United Kingdom
190
190
Date Agreed
30/09/2016
52
01/08/2016
52
Recruitment
Finished
Comments
Termiated early due to
global target reached
Page 2 of 2