Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00689104




Registration number
NCT00689104
Ethics application status
Date submitted
29/05/2008
Date registered
3/06/2008
Date last updated
20/11/2024

Titles & IDs
Public title
Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
Scientific title
A Randomized, Double-Blind, Parallel Group, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron in Subjects With Symptoms of Overactive Bladder
Secondary ID [1] 0 0
2007-001451-19
Secondary ID [2] 0 0
178-CL-046
Universal Trial Number (UTN)
Trial acronym
SCORPIO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Bladder, Overactive 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mirabegron
Treatment: Drugs - Tolterodine
Treatment: Drugs - Placebo to Mirabegron
Treatment: Drugs - Placebo to Tolterodine

Placebo comparator: Placebo - Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.

Experimental: Mirabegron 50 mg - Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.

Experimental: Mirabegron 100 mg - Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.

Active comparator: Tolterodine SR 4 mg - Participants received tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.


Treatment: Drugs: Mirabegron
Tablets

Treatment: Drugs: Tolterodine
Capsules

Treatment: Drugs: Placebo to Mirabegron
Matching mirabegron placebo tablets.

Treatment: Drugs: Placebo to Tolterodine
Matching tolterodine placebo capsules.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours
Timepoint [1] 0 0
Baseline and Week 12 (final visit)
Primary outcome [2] 0 0
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
Change From Baseline to Final Visit in Mean Volume Voided Per Micturition
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours
Timepoint [2] 0 0
Baseline and Week 4
Secondary outcome [3] 0 0
Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours
Timepoint [3] 0 0
Baseline and Week 4
Secondary outcome [4] 0 0
Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
Timepoint [4] 0 0
Baseline and Weeks 8 and 12
Secondary outcome [5] 0 0
Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours
Timepoint [5] 0 0
Baseline and Weeks 8 and 12
Secondary outcome [6] 0 0
Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition
Timepoint [6] 0 0
Baseline and Weeks 4, 8 and 12
Secondary outcome [7] 0 0
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Timepoint [7] 0 0
Baseline and Weeks 4, 8 and 12
Secondary outcome [8] 0 0
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours
Timepoint [8] 0 0
Baseline and Weeks 4, 8 and 12
Secondary outcome [9] 0 0
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency
Timepoint [9] 0 0
Baseline and Weeks 4, 8 and 12
Secondary outcome [10] 0 0
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours
Timepoint [10] 0 0
Baseline and Weeks 4, 8 and 12
Secondary outcome [11] 0 0
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours
Timepoint [11] 0 0
Baseline and Weeks 4, 8 and 12
Secondary outcome [12] 0 0
Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit
Timepoint [12] 0 0
Weeks 4, 8 and 12
Secondary outcome [13] 0 0
Percentage of Participants With = 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
Timepoint [13] 0 0
Baseline and Weeks 4, 8 and 12
Secondary outcome [14] 0 0
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score
Timepoint [14] 0 0
Baseline and Weeks 4, 8 and 12
Secondary outcome [15] 0 0
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score
Timepoint [15] 0 0
Baseline and Weeks 4, 8 and 12
Secondary outcome [16] 0 0
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
Timepoint [16] 0 0
Baseline and Week 12
Secondary outcome [17] 0 0
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
Timepoint [17] 0 0
Baseline and Week 12
Secondary outcome [18] 0 0
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
Timepoint [18] 0 0
Baseline and Week 12
Secondary outcome [19] 0 0
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
Timepoint [19] 0 0
Baseline and Week 12
Secondary outcome [20] 0 0
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
Timepoint [20] 0 0
Baseline and Week 12
Secondary outcome [21] 0 0
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
Timepoint [21] 0 0
Baseline and Week 12
Secondary outcome [22] 0 0
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
Timepoint [22] 0 0
Baseline and Week 12
Secondary outcome [23] 0 0
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
Timepoint [23] 0 0
Baseline and Week 12
Secondary outcome [24] 0 0
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score
Timepoint [24] 0 0
Baseline and Week 12
Secondary outcome [25] 0 0
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
Timepoint [25] 0 0
Baseline and Weeks 4, 8 and 12
Secondary outcome [26] 0 0
Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)
Timepoint [26] 0 0
Baseline and Week 12
Secondary outcome [27] 0 0
Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
Timepoint [27] 0 0
Baseline and Week 12
Secondary outcome [28] 0 0
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician
Timepoint [28] 0 0
Baseline and Weeks 4, 8 and 12
Secondary outcome [29] 0 0
Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit
Timepoint [29] 0 0
Baseline and Week 12

Eligibility
Key inclusion criteria
* Subject is willing and able to complete the micturition diary and questionnaires correctly
* Subject has symptoms of overactive bladder (urinary frequency and urgency with or without urge incontinence) for = 3 months
* Subject experiences frequency of micturition on average = 8 times per 24-hour period during the 3-day micturition diary period
* Subject must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence, during the 3-day micturition diary period
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control
* Subject has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
* 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 receives non-drug treatment including electro-stimulation therapy
* Subject has severe hypertension
* Subject has a known or suspected hypersensitivity to tolterodine, other anticholinergics, YM178, other beta-adrenoreceptor (ß-AR) agonists, or lactose or any of the other inactive ingredients
* Subject has been treated with any investigational drug or device within 30 days (90 days in the UK)
* Subject had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period
* Subject has serum creatinine >150 umol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2x upper limit of normal range (ULN), or gamma glutamyl transferase (?-GT) > 3x ULN
* Subject has a clinically significant abnormal electrocardiogram (ECG)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/03/2009
Sample size
Target
Accrual to date
Final
2336
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Auchenflower
Recruitment hospital [2] 0 0
- Clayton
Recruitment hospital [3] 0 0
- Kogarah
Recruitment hospital [4] 0 0
- Randwick
Recruitment hospital [5] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
- Auchenflower
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Kogarah
Recruitment postcode(s) [4] 0 0
- Randwick
Recruitment postcode(s) [5] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Linz
Country [4] 0 0
Belarus
State/province [4] 0 0
Minsk
Country [5] 0 0
Belgium
State/province [5] 0 0
Antwerp
Country [6] 0 0
Belgium
State/province [6] 0 0
Brussels
Country [7] 0 0
Belgium
State/province [7] 0 0
Edegem
Country [8] 0 0
Belgium
State/province [8] 0 0
Gent
Country [9] 0 0
Belgium
State/province [9] 0 0
Kortrijk
Country [10] 0 0
Belgium
State/province [10] 0 0
Leper
Country [11] 0 0
Belgium
State/province [11] 0 0
Leuven
Country [12] 0 0
Belgium
State/province [12] 0 0
Liege
Country [13] 0 0
Belgium
State/province [13] 0 0
Sint Truiden
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Pleven
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Sofia
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Varna
Country [17] 0 0
Czechia
State/province [17] 0 0
Brno
Country [18] 0 0
Czechia
State/province [18] 0 0
Melnik
Country [19] 0 0
Czechia
State/province [19] 0 0
Olomouc
Country [20] 0 0
Czechia
State/province [20] 0 0
Ostrava-Poruba
Country [21] 0 0
Czechia
State/province [21] 0 0
Plzen
Country [22] 0 0
Czechia
State/province [22] 0 0
Prague
Country [23] 0 0
Czechia
State/province [23] 0 0
Steti
Country [24] 0 0
Czechia
State/province [24] 0 0
Usti nad Labem
Country [25] 0 0
Denmark
State/province [25] 0 0
Aalborg
Country [26] 0 0
Denmark
State/province [26] 0 0
Aarhus
Country [27] 0 0
Denmark
State/province [27] 0 0
Glostrup
Country [28] 0 0
Denmark
State/province [28] 0 0
Roskilde
Country [29] 0 0
Finland
State/province [29] 0 0
Helsinki
Country [30] 0 0
Finland
State/province [30] 0 0
Oulu
Country [31] 0 0
Finland
State/province [31] 0 0
Tampere
Country [32] 0 0
Finland
State/province [32] 0 0
Turku
Country [33] 0 0
France
State/province [33] 0 0
Bordeaux
Country [34] 0 0
France
State/province [34] 0 0
Colmar
Country [35] 0 0
France
State/province [35] 0 0
Marseille Cedex 9
Country [36] 0 0
France
State/province [36] 0 0
Marseille
Country [37] 0 0
France
State/province [37] 0 0
Mulhouse
Country [38] 0 0
France
State/province [38] 0 0
Nantes
Country [39] 0 0
France
State/province [39] 0 0
Nimes Cedex 9
Country [40] 0 0
France
State/province [40] 0 0
Orleans Cedex 2
Country [41] 0 0
France
State/province [41] 0 0
Paris-Cedex 12
Country [42] 0 0
France
State/province [42] 0 0
Paris
Country [43] 0 0
France
State/province [43] 0 0
Rouen
Country [44] 0 0
France
State/province [44] 0 0
Saint Priest en Jarez
Country [45] 0 0
France
State/province [45] 0 0
Strasbourg
Country [46] 0 0
France
State/province [46] 0 0
Toulouse Cedex 9
Country [47] 0 0
Germany
State/province [47] 0 0
Aichach
Country [48] 0 0
Germany
State/province [48] 0 0
Bad Ems
Country [49] 0 0
Germany
State/province [49] 0 0
Bautzen
Country [50] 0 0
Germany
State/province [50] 0 0
Berlin
Country [51] 0 0
Germany
State/province [51] 0 0
Duisburg
Country [52] 0 0
Germany
State/province [52] 0 0
Frankfurt
Country [53] 0 0
Germany
State/province [53] 0 0
Ganderkesee
Country [54] 0 0
Germany
State/province [54] 0 0
Hagenow
Country [55] 0 0
Germany
State/province [55] 0 0
Halle/Saale
Country [56] 0 0
Germany
State/province [56] 0 0
Hamburg
Country [57] 0 0
Germany
State/province [57] 0 0
Henningsdorf
Country [58] 0 0
Germany
State/province [58] 0 0
Hettstedt
Country [59] 0 0
Germany
State/province [59] 0 0
Koblenz
Country [60] 0 0
Germany
State/province [60] 0 0
Leipzig
Country [61] 0 0
Germany
State/province [61] 0 0
Lutherstadt Eisleben
Country [62] 0 0
Germany
State/province [62] 0 0
Muenchen-Bogenhausen
Country [63] 0 0
Germany
State/province [63] 0 0
Neustadt I. Sachsen
Country [64] 0 0
Germany
State/province [64] 0 0
Oranienburg
Country [65] 0 0
Germany
State/province [65] 0 0
Radebeul
Country [66] 0 0
Germany
State/province [66] 0 0
Sangerhausen
Country [67] 0 0
Germany
State/province [67] 0 0
Trier
Country [68] 0 0
Germany
State/province [68] 0 0
Uetersen
Country [69] 0 0
Greece
State/province [69] 0 0
Athens
Country [70] 0 0
Greece
State/province [70] 0 0
Nikaias-Piraeus
Country [71] 0 0
Greece
State/province [71] 0 0
Patras
Country [72] 0 0
Greece
State/province [72] 0 0
Thessaloniki
Country [73] 0 0
Hungary
State/province [73] 0 0
Budapest
Country [74] 0 0
Hungary
State/province [74] 0 0
Debrecen
Country [75] 0 0
Hungary
State/province [75] 0 0
Eger
Country [76] 0 0
Hungary
State/province [76] 0 0
Nyiregyhaza
Country [77] 0 0
Hungary
State/province [77] 0 0
Papa
Country [78] 0 0
Hungary
State/province [78] 0 0
Sopron
Country [79] 0 0
Hungary
State/province [79] 0 0
Szeged
Country [80] 0 0
Hungary
State/province [80] 0 0
Szekesfehervar
Country [81] 0 0
Hungary
State/province [81] 0 0
Szekszard
Country [82] 0 0
Hungary
State/province [82] 0 0
Tatabanya
Country [83] 0 0
Hungary
State/province [83] 0 0
Veszprem
Country [84] 0 0
Iceland
State/province [84] 0 0
Reykjavik
Country [85] 0 0
Ireland
State/province [85] 0 0
Cork
Country [86] 0 0
Ireland
State/province [86] 0 0
Dublin 9
Country [87] 0 0
Ireland
State/province [87] 0 0
Dublin
Country [88] 0 0
Ireland
State/province [88] 0 0
Mullingar
Country [89] 0 0
Ireland
State/province [89] 0 0
Tralee
Country [90] 0 0
Italy
State/province [90] 0 0
Bari
Country [91] 0 0
Italy
State/province [91] 0 0
Catanzaro
Country [92] 0 0
Italy
State/province [92] 0 0
Florence
Country [93] 0 0
Italy
State/province [93] 0 0
Genoa
Country [94] 0 0
Italy
State/province [94] 0 0
Latina
Country [95] 0 0
Italy
State/province [95] 0 0
Magenta
Country [96] 0 0
Italy
State/province [96] 0 0
Milan
Country [97] 0 0
Italy
State/province [97] 0 0
Modena
Country [98] 0 0
Italy
State/province [98] 0 0
Naples
Country [99] 0 0
Italy
State/province [99] 0 0
Perugia
Country [100] 0 0
Italy
State/province [100] 0 0
Teramo
Country [101] 0 0
Italy
State/province [101] 0 0
Treviglio
Country [102] 0 0
Italy
State/province [102] 0 0
Varese
Country [103] 0 0
Latvia
State/province [103] 0 0
Liepaja
Country [104] 0 0
Latvia
State/province [104] 0 0
Riga
Country [105] 0 0
Lithuania
State/province [105] 0 0
Kaunas
Country [106] 0 0
Lithuania
State/province [106] 0 0
Vilnius
Country [107] 0 0
Netherlands
State/province [107] 0 0
Amsterdam
Country [108] 0 0
Netherlands
State/province [108] 0 0
Apeldoorn
Country [109] 0 0
Netherlands
State/province [109] 0 0
Eindhoven
Country [110] 0 0
Netherlands
State/province [110] 0 0
Enschede
Country [111] 0 0
Netherlands
State/province [111] 0 0
Leiden
Country [112] 0 0
Netherlands
State/province [112] 0 0
Maastricht
Country [113] 0 0
Netherlands
State/province [113] 0 0
Nijmegen
Country [114] 0 0
Netherlands
State/province [114] 0 0
Sneek
Country [115] 0 0
Netherlands
State/province [115] 0 0
Tilburg
Country [116] 0 0
Netherlands
State/province [116] 0 0
Winterswijk
Country [117] 0 0
Norway
State/province [117] 0 0
Bergen
Country [118] 0 0
Norway
State/province [118] 0 0
Drammen
Country [119] 0 0
Norway
State/province [119] 0 0
Hamar
Country [120] 0 0
Norway
State/province [120] 0 0
Oslo
Country [121] 0 0
Norway
State/province [121] 0 0
Tonsberg
Country [122] 0 0
Poland
State/province [122] 0 0
Bialystok
Country [123] 0 0
Poland
State/province [123] 0 0
Chorzow
Country [124] 0 0
Poland
State/province [124] 0 0
Lodz
Country [125] 0 0
Poland
State/province [125] 0 0
Lublin
Country [126] 0 0
Poland
State/province [126] 0 0
Warsaw
Country [127] 0 0
Poland
State/province [127] 0 0
Wroclaw
Country [128] 0 0
Portugal
State/province [128] 0 0
Amadora
Country [129] 0 0
Portugal
State/province [129] 0 0
Porto
Country [130] 0 0
Portugal
State/province [130] 0 0
Tomar
Country [131] 0 0
Portugal
State/province [131] 0 0
Viana do Castelo
Country [132] 0 0
Romania
State/province [132] 0 0
Bucharest
Country [133] 0 0
Romania
State/province [133] 0 0
Lasi
Country [134] 0 0
Romania
State/province [134] 0 0
Oradea
Country [135] 0 0
Romania
State/province [135] 0 0
Timisoara
Country [136] 0 0
Russian Federation
State/province [136] 0 0
Moscow
Country [137] 0 0
Russian Federation
State/province [137] 0 0
St. Petersburg
Country [138] 0 0
Slovakia
State/province [138] 0 0
Martin
Country [139] 0 0
Slovakia
State/province [139] 0 0
Poprad
Country [140] 0 0
Slovakia
State/province [140] 0 0
Skalica
Country [141] 0 0
Slovakia
State/province [141] 0 0
Trencin
Country [142] 0 0
Slovakia
State/province [142] 0 0
Zilina
Country [143] 0 0
South Africa
State/province [143] 0 0
Bloemfontein
Country [144] 0 0
South Africa
State/province [144] 0 0
Hatfield
Country [145] 0 0
South Africa
State/province [145] 0 0
Lyttelton
Country [146] 0 0
South Africa
State/province [146] 0 0
Paarl
Country [147] 0 0
South Africa
State/province [147] 0 0
Pietermaritzburg
Country [148] 0 0
Spain
State/province [148] 0 0
Barcelona
Country [149] 0 0
Spain
State/province [149] 0 0
Bilbao
Country [150] 0 0
Spain
State/province [150] 0 0
Esplugues De Llobregat-Barcelo
Country [151] 0 0
Spain
State/province [151] 0 0
Fuenlabrada
Country [152] 0 0
Spain
State/province [152] 0 0
Getafe
Country [153] 0 0
Spain
State/province [153] 0 0
Madrid
Country [154] 0 0
Spain
State/province [154] 0 0
Mataro
Country [155] 0 0
Spain
State/province [155] 0 0
Miranda de Ebro
Country [156] 0 0
Spain
State/province [156] 0 0
Palma de Mallorca
Country [157] 0 0
Spain
State/province [157] 0 0
Sevilla
Country [158] 0 0
Spain
State/province [158] 0 0
Toledo
Country [159] 0 0
Spain
State/province [159] 0 0
Valencia
Country [160] 0 0
Spain
State/province [160] 0 0
Villareal
Country [161] 0 0
Sweden
State/province [161] 0 0
Boras
Country [162] 0 0
Sweden
State/province [162] 0 0
Helsingborg
Country [163] 0 0
Sweden
State/province [163] 0 0
Orebro
Country [164] 0 0
Sweden
State/province [164] 0 0
Skovde
Country [165] 0 0
Sweden
State/province [165] 0 0
Stockholm
Country [166] 0 0
Sweden
State/province [166] 0 0
Umea
Country [167] 0 0
Sweden
State/province [167] 0 0
Uppsala
Country [168] 0 0
Switzerland
State/province [168] 0 0
Frauenfeld
Country [169] 0 0
Switzerland
State/province [169] 0 0
Luzern
Country [170] 0 0
Ukraine
State/province [170] 0 0
Kiev
Country [171] 0 0
United Kingdom
State/province [171] 0 0
Birmingham
Country [172] 0 0
United Kingdom
State/province [172] 0 0
Chorley
Country [173] 0 0
United Kingdom
State/province [173] 0 0
Croydon
Country [174] 0 0
United Kingdom
State/province [174] 0 0
Liverpool
Country [175] 0 0
United Kingdom
State/province [175] 0 0
London
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Manchester
Country [177] 0 0
United Kingdom
State/province [177] 0 0
Newcastle Upon Tyne
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Northwood
Country [179] 0 0
United Kingdom
State/province [179] 0 0
Reading
Country [180] 0 0
United Kingdom
State/province [180] 0 0
Sheffield
Country [181] 0 0
United Kingdom
State/province [181] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.
Trial website
https://clinicaltrials.gov/study/NCT00689104
Trial related presentations / publications
Khullar V, Amarenco G, Angulo JC, Cambronero J, Hoye K, Milsom I, Radziszewski P, Rechberger T, Boerrigter P, Drogendijk T, Wooning M, Chapple C. Efficacy and tolerability of mirabegron, a beta(3)-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial. Eur Urol. 2013 Feb;63(2):283-95. doi: 10.1016/j.eururo.2012.10.016. Epub 2012 Nov 6.
Desroziers K, Aballea S, Maman K, Nazir J, Odeyemi I, Hakimi Z. Estimating EQ-5D and OAB-5D health state utilities for patients with overactive bladder. Health Qual Life Outcomes. 2013 Nov 19;11:200. doi: 10.1186/1477-7525-11-200.
Public notes

Contacts
Principal investigator
Name 0 0
Central Contact
Address 0 0
Astellas Pharma Europe B.V.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00689104