Clinical trial NCT01638000: A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.
Official title: A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects With Overactive Bladder (OAB) Treated With Antimuscarinics and Dissatisfied Due to Lack of Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urologic Diseases
Urinary Bladder, Overactive
Urinary Bladder Diseases
Keywords: Vesitrim
Frequency
Urgency
Urgency incontinence
Urinary incontinence
Overactive Bladder (OAB)
Micturition
Mirabegron
YM178
Vesicare
Solifenacin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-07-11
Enrollment: 1887
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.


Eligibility criteria: Inclusion Criteria:

* Subject is willing and able to complete the micturition diary and questionnaires correctly
* Subject has symptoms of OAB (urinary frequency and urgency with or without urgency incontinence) for at least 3 months
* Subject is currently or has previously received at least one antimuscarinic agent intended to treat their OAB. The last antimuscarinic must have been taken for at least 4 weeks and taken within 6 months prior to the Screening Visit

Exclusion Criteria:

* Female subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential is sexually active and not practicing a highly reliable method of birth control
* Subject has neurogenic bladder
* Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator (for female subjects confirmed by a cough provocation test)
* Subject has an indwelling catheter or practices intermittent self-catheterization
* Subject has diabetic neuropathy
* Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
* Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis, toxic megacolon, myasthenia gravis or any other medical condition which makes the use of anticholinergics contraindicated
* The subject is currently receiving or has a history of treatment with intravesical botulinum toxin (cosmetic use is acceptable) or resiniferatoxin within 9 months prior to screening
* Subject receives non-drug treatment including electro-stimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to screening)
* Subject has moderate to severe hepatic impairment
* Subject has severe renal impairment or end stage renal disease
* Subject has severe uncontrolled hypertension
* Subject has a clinically significant abnormal electrocardiogram (ECG) or has a known history of QT prolongation or currently taking medication known to prolong the QT interval
* Subject has a known or suspected hypersensitivity to solifenacin, mirabegron or any of the inactive ingredients
* Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening
* Subject has been treated with an experimental device within 30 days or received an experimental agent within the longer of 30 days or five half-lives
* Subject is using prohibited medications which cannot be stopped safely at the Screening Visit. Subject is excluded if using restricted medications not meeting protocol-specified criteria
* Subject's last antimuscarinic treatment was solifenacin

Primary outcomes:
measure: Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours
timeFrame: Baseline and final visit (up to Week 12)
Secondary outcomes:
measure: Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period
timeFrame: From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks)
measure: Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours
timeFrame: Baseline and Week 4, Week 8, Week 12
measure: Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
timeFrame: Week 4, Week 8, Week 12
measure: Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
timeFrame: Baseline and Week 4, Week 8, Week 12
measure: Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
timeFrame: Week 4, Week 8, Week 12
measure: Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
timeFrame: Baseline and Week 4, Week 8, Week 12
measure: Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
timeFrame: Baseline and Week 4, Week 8, Week 12
measure: Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency
timeFrame: Baseline and Week 4, Week 8, Week 12
measure: Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit
timeFrame: Week 4, Week 8, Week 12
measure: Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment
timeFrame: Baseline and Week 4, Week 8 , Week 12
measure: Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
timeFrame: Week 4, Week 8, Week 12
measure: Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment
timeFrame: Baseline and Week 4, Week 8, Week 12
measure: Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit
timeFrame: Week 4, Week 8, Week 12
measure: Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit
timeFrame: Week 4, Week 8, Week 12
measure: Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit
timeFrame: Week 4, Week 8, Week 12
measure: Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire
timeFrame: Baseline and Week 4
measure: Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
timeFrame: Baseline and Week 4
measure: Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
timeFrame: Baseline and Week 4
measure: Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
timeFrame: Baseline and Week 4
measure: Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
timeFrame: Baseline and Week 4
measure: Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
timeFrame: Baseline and Week 8
measure: Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
timeFrame: Baseline and Week 8
measure: Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
timeFrame: Baseline and Week 8
measure: Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
timeFrame: Baseline and Week 8
measure: Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
timeFrame: Baseline and Week 8
measure: Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
timeFrame: Baseline and Week 12
measure: Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
timeFrame: Baseline and final visit (up to Week 12)
measure: Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
timeFrame: Baseline and final visit (up to Week 12)
measure: Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
timeFrame: Baseline and final visit (up to Week 12)
measure: Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
timeFrame: Baseline and final visit (up to Week 12)
measure: Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
timeFrame: Baseline and final visit (up to Week 12)
measure: Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)
timeFrame: Baseline and Week 4, Week 8, Week 12
measure: Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q
timeFrame: Baseline and Week 4, Week 8, Week 12
measure: Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)
timeFrame: Baseline and Week 4, Week 8, Week 12
measure: Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale
timeFrame: Baseline and Week 12
measure: Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit
timeFrame: Baseline to Week 12
measure: Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit
timeFrame: Baseline to Week 12
measure: Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12
timeFrame: Baseline to Week 12
measure: Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit
timeFrame: Baseline to final visit (up to Week 12)
measure: Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit
timeFrame: Baseline to Week 12
measure: Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: Site: 37406
city: Yerevan
country: Armenia
facility: Site: 37404
city: Yerevan
country: Armenia
facility: Site: 37403
city: Yerevan
country: Armenia
facility: Site: 37401
city: Yerevan
country: Armenia
facility: Site: 37402
city: Baden
country: Austria
facility: Site: 43006
city: Graz
country: Austria
facility: Site: 43014
city: Innsbruck
country: Austria
facility: Site: 43015
city: Linz
country: Austria
facility: Site: 43013
city: Oberwart
country: Austria
facility: Site: 43005
city: Vienna
country: Austria
facility: Site: 43011
city: Vienna
country: Austria
facility: Site: 43002
city: Wels
country: Austria
facility: Site: 43003
city: Minsk
country: Belarus
facility: Site: 37502
city: Minsk
country: Belarus
facility: Site: 37501
city: Vitebsk
country: Belarus
facility: Site: 37504
city: Brussels
country: Belgium
facility: Site: 32006
city: Deurne
country: Belgium
facility: Site: 32008
city: Edegem
country: Belgium
facility: Site: 32001
city: Gent
country: Belgium
facility: Site: 32004
city: Leuven
country: Belgium
facility: Site: 32007
city: Liege
country: Belgium
facility: Site: 32005
city: Burgas
country: Bulgaria
facility: Site: 35902
city: Haskovo
country: Bulgaria
facility: Site: 35909
city: Lovech
country: Bulgaria
facility: Site: 35901
city: Plovdiv
country: Bulgaria
facility: Site: 35905
city: Sofia
country: Bulgaria
facility: Site: 35906
city: Sofia
country: Bulgaria
facility: Site: 35908
city: Sofia
country: Bulgaria
facility: Site: 35903
city: Abbotsford
country: Canada
facility: Site: 10010
city: Barrie
country: Canada
facility: Site: 10011
city: Bathurst
country: Canada
facility: Site: 10001
city: Brampton
country: Canada
facility: Site: 10003
city: Brantford
country: Canada
facility: Site: 10005
city: Kingston
country: Canada
facility: Site: 10007
city: Montreal
country: Canada
facility: Site: 10002
city: Sherbrooke
country: Canada
facility: Site: 10009
city: Toronto
country: Canada
facility: Site: 10004
city: Victoria
country: Canada
facility: Site: 10008
city: Bohumin
country: Czechia
facility: Site: 42004
city: Brno
country: Czechia
facility: Site: 42003
city: Hradec Kralove
country: Czechia
facility: Site: 42001
city: Jihlava
country: Czechia
facility: Site: 42002
city: Plzen-Lochotin
country: Czechia
facility: Site: 42006
city: Prague 1
country: Czechia
facility: Site: 42005
city: Prague 4
country: Czechia
facility: Site: 42007
city: Prague
country: Czechia
facility: Site: 42008
city: Aalborg
country: Denmark
facility: Site: 45002
city: Aarhus N
country: Denmark
facility: Site: 45001
city: Frederiksbjerg
country: Denmark
facility: Site: 45005
city: Hvidovre
country: Denmark
facility: Site: 45004
city: Odense C
country: Denmark
facility: Site: 45003
city: Jyvaskyla
country: Finland
facility: Site: 35802
city: Oulu
country: Finland
facility: Site: 35801
city: Tampere
country: Finland
facility: Site: 35804
city: Angers
country: France
facility: Site: 33010
city: Colmar Cedex
country: France
facility: Site: 33007
city: Dijon
country: France
facility: Site: 33011
city: Marseille
country: France
facility: Site: 33002
city: Marseille
country: France
facility: Site: 33006
city: Nimes
country: France
facility: Site: 33013
city: Orleans Cedex 2
country: France
facility: Site: 33004
city: Paris Cedex 20
country: France
facility: Site: 33001
city: Paris Cedex 20
country: France
facility: Site: 33005
city: Rouen
country: France
facility: Site: 33003
city: Suresnes Cedex
country: France
facility: Site: 33014
city: Tours
country: France
facility: Site: 33017
city: Valence
country: France
facility: Site: 33015
city: Tbilisi
country: Georgia
facility: Site: 99501
city: Tbilisi
country: Georgia
facility: Site: 99502
city: Tbilisi
country: Georgia
facility: Site: 99503
city: Bad Ems
country: Germany
facility: Site: 49006
city: Halle Saale
country: Germany
facility: Site: 49009
city: Alexandroupoli
country: Greece
facility: Site: 30005
city: Athens
country: Greece
facility: Site: 30009
city: Athens
country: Greece
facility: Site: 30007
city: Athens
country: Greece
facility: Site: 30001
city: Herakleion
country: Greece
facility: Site: 30006
city: Larisa
country: Greece
facility: Site: 30008
city: Patras
country: Greece
facility: Site: 30004
city: Thessaloniki
country: Greece
facility: Site: 30010
city: Thessaloniki
country: Greece
facility: Site: 30002
city: Budapest
country: Hungary
facility: Site: 36003
city: Budapest
country: Hungary
facility: Site: 36004
city: Csongrad
country: Hungary
facility: Site: 36005
city: Nyiregyhaza
country: Hungary
facility: Site: 36006
city: Salgotarjan
country: Hungary
facility: Site: 36001
city: Szekszard
country: Hungary
facility: Site: 36002
city: Cork
country: Ireland
facility: Site: 35304
city: Dublin
country: Ireland
facility: Site: 35302
city: Dublin
country: Ireland
facility: Site: 35306
city: Dublin
country: Ireland
facility: Site: 35301
city: Tralee
country: Ireland
facility: Site: 35303
city: Waterford
country: Ireland
facility: Site: 35305
city: Avellino
country: Italy
facility: Site: 39001
city: Catanzaro
country: Italy
facility: Site: 39005
city: Cinisello Balsamo
country: Italy
facility: Site: 39003
city: Florence
country: Italy
facility: Site: 39002
city: Milan
country: Italy
facility: Site: 39008
city: Pavia
country: Italy
facility: Site: 39010
city: Perugia
country: Italy
facility: Site: 39006
city: Treviglio
country: Italy
facility: Site: 39007
city: Almaty
country: Kazakhstan
facility: Site: 77705
city: Almaty
country: Kazakhstan
facility: Site: 77706
city: Astana
country: Kazakhstan
facility: Site: 77703
city: Astana
country: Kazakhstan
facility: Site: 77702
city: Liepaja
country: Latvia
facility: Site: 37103
city: Riga
country: Latvia
facility: Site: 37102
city: Riga
country: Latvia
facility: Site: 37101
city: Achrafieh
country: Lebanon
facility: Site: 96103
city: Jbeil
country: Lebanon
facility: Site: 96102
city: Kaunas
country: Lithuania
facility: Site: 37001
city: Vilnius
country: Lithuania
facility: Site: 37003
city: Amsterdam
country: Netherlands
facility: Site: 31010
city: Eindhoven
country: Netherlands
facility: Site: 31005
city: Enschede
country: Netherlands
facility: Site: 31004
city: Nijmegen
country: Netherlands
facility: Site: 31007
city: Tilburg
country: Netherlands
facility: Site: 31001
city: Utrecht
country: Netherlands
facility: Site: 31008
city: Zwolle
country: Netherlands
facility: Site: 31006
city: Hamar
country: Norway
facility: Site: 47002
city: Tonsberg
country: Norway
facility: Site: 47001
city: Trondheim
country: Norway
facility: Site: 47005
city: Kolbuszowa Dolna
country: Poland
facility: Site: 48007
city: Krakow
country: Poland
facility: Site: 48006
city: Lublin
country: Poland
facility: Site: 48001
city: Piaseczno
country: Poland
facility: Site: 48004
city: Warsaw
country: Poland
facility: Site: 48003
city: Wroclaw
country: Poland
facility: Site: 48005
city: Lisbon
country: Portugal
facility: Site: 35105
city: Lisbon
country: Portugal
facility: Site: 35104
city: Matosinhos
country: Portugal
facility: Site: 35102
city: Porto
country: Portugal
facility: Site: 35103
city: Setubal
country: Portugal
facility: Site: 35101
city: Moscow
country: Russian Federation
facility: Site: 70007
city: Moscow
country: Russian Federation
facility: Site: 70001
city: Moscow
country: Russian Federation
facility: Site: 70008
city: Moscow
country: Russian Federation
facility: Site: 70005
city: Moscow
country: Russian Federation
facility: Site: 70006
city: Moscow
country: Russian Federation
facility: Site: 70011
city: Moscow
country: Russian Federation
facility: Site: 70002
city: Moscow
country: Russian Federation
facility: Site: 70003
city: Saint Petersburg
country: Russian Federation
facility: Site: 70013
city: Saint Petersburg
country: Russian Federation
facility: Site: 70012
city: Saint Petersburg
country: Russian Federation
facility: Site: 70010
city: Saint Petersburg
country: Russian Federation
facility: Site: 70009
city: St. Petersburg
country: Russian Federation
facility: Site: 70004
city: Galanta
country: Slovakia
facility: Site: 42104
city: Martin
country: Slovakia
facility: Site: 42106
city: Piestany
country: Slovakia
facility: Site: 42103
city: Poprad
country: Slovakia
facility: Site: 42101
city: Trencin
country: Slovakia
facility: Site: 42105
city: Zilina
country: Slovakia
facility: Site: 42102
city: Ljubljana
country: Slovenia
facility: Site: 38603
city: Ljubljana
country: Slovenia
facility: Site: 38604
city: Maribor
country: Slovenia
facility: Site: 38601
city: Maribor
country: Slovenia
facility: Site: 38602
city: Novo Mesto
country: Slovenia
facility: Site: 38606
city: Barcelona
country: Spain
facility: Site: 34001
city: Barcelona
country: Spain
facility: Site: 34002
city: Bilbao
country: Spain
facility: Site: 34009
city: Madrid
country: Spain
facility: Site: 34004
city: Madrid
country: Spain
facility: Site: 34005
city: Madrid
country: Spain
facility: Site: 34003
city: Mendaro
country: Spain
facility: Site: 34011
city: Murcia
country: Spain
facility: Site: 34013
city: San Sebastian
country: Spain
facility: Site: 34010
city: Sevilla
country: Spain
facility: Site: 34014
city: Valencia
country: Spain
facility: Site: 34012
city: Gothenburg
country: Sweden
facility: Site: 46007
city: Halmstad
country: Sweden
facility: Site: 46004
city: Karlshamn
country: Sweden
facility: Site: 46005
city: Norrtalje
country: Sweden
facility: Site: 46003
city: Stockholm
country: Sweden
facility: Site: 46002
city: Stockholm
country: Sweden
facility: Site: 46001
city: Uppsala
country: Sweden
facility: Site: 46006
city: Frauenfeld
country: Switzerland
facility: Site: 41001
city: Zurich
country: Switzerland
facility: Site: 41003
city: Ankara
country: Turkey
facility: Site: 90005
city: Ankara
country: Turkey
facility: Site: 90003
city: Denizli
country: Turkey
facility: Site: 90011
city: Diyarbakir
country: Turkey
facility: Site: 90007
city: Istanbul
country: Turkey
facility: Site: 90004
city: Izmir
country: Turkey
facility: Site: 90001
city: Izmir
country: Turkey
facility: Site: 90008
city: Manisa
country: Turkey
facility: Site: 90009
city: Sivas
country: Turkey
facility: Site: 90010
city: Chernivtsi
country: Ukraine
facility: Site: 38007
city: Dnepropetrovsk
country: Ukraine
facility: Site: 38004
city: Kharkov
country: Ukraine
facility: Site: 38001
city: Kiev
country: Ukraine
facility: Site: 38002
city: Lviv
country: Ukraine
facility: Site: 38003
city: Aberdeen
country: United Kingdom
facility: Site: 44027
city: Birmingham
country: United Kingdom
facility: Site: 44029
city: Cambridge
country: United Kingdom
facility: Site: 44025
city: Chichester
country: United Kingdom
facility: Site: 44030
city: Croydon
country: United Kingdom
facility: Site: 44028
city: Devon
country: United Kingdom
facility: Site: 44003
city: Edgbaston
country: United Kingdom
facility: Site: 44001
city: Glasgow
country: United Kingdom
facility: Site: 44011
city: Harrow
country: United Kingdom
facility: Site: 44023
city: Kent
country: United Kingdom
facility: Site: 44006
city: Leeds
country: United Kingdom
facility: Site: 44012
city: Leicester
country: United Kingdom
facility: Site: 44019
city: Liverpool
country: United Kingdom
facility: Site: 44008
city: London
country: United Kingdom
facility: Site: 44010
city: London
country: United Kingdom
facility: Site: 44017
city: Newcastle upon Tyne
country: United Kingdom
facility: Site: 44013
city: Northwood
country: United Kingdom
facility: Site: 44022
city: Nottingham
country: United Kingdom
facility: Site: 44021
city: Plymouth
country: United Kingdom
facility: Site: 44009
city: Reading
country: United Kingdom
facility: Site: 44007
city: Sheffield
country: United Kingdom
facility: Site: 44005
city: Southampton
country: United Kingdom
facility: Site: 44020
city: Taunton
country: United Kingdom
facility: Site: 44026
city: West Yorkshire
country: United Kingdom
facility: Site: 44024
city: West Yorkshire
country: United Kingdom
facility: Site: 44002
Study officials:
affiliation: Astellas Pharma Europe Ltd.
name: Clinical Study Manager
role: STUDY_DIRECTOR
References: