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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00688688




Registration number
NCT00688688
Ethics application status
Date submitted
29/05/2008
Date registered
3/06/2008

Titles & IDs
Public title
Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
Scientific title
A Randomized, Double-Blind, Parallel Group, Active Controlled, Multi-center Long-term Study to Assess the Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) 50 mg qd and 100 mg qd in Subjects With Symptoms of Overactive Bladder
Secondary ID [1] 0 0
2007-001452-39
Secondary ID [2] 0 0
178-CL-049
Universal Trial Number (UTN)
Trial acronym
TAURUS
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

Experimental: Mirabegron 50 mg - Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.

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

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


Treatment: Drugs: Mirabegron
Tablets

Treatment: Drugs: Tolterodine
Extended release 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
Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.
Secondary outcome [1] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours
Timepoint [1] 0 0
Baseline and Months 1, 3, 6, 9 and 12
Secondary outcome [2] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours
Timepoint [2] 0 0
Baseline and Months 1, 3, 6, 9 and 12
Secondary outcome [3] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition
Timepoint [3] 0 0
Baseline and Months 1, 3, 6, 9 and 12
Secondary outcome [4] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Timepoint [4] 0 0
Baseline and Months 1, 3, 6, 9 and 12
Secondary outcome [5] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
Timepoint [5] 0 0
Baseline and Months 1, 3, 6, 9 and 12
Secondary outcome [6] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency
Timepoint [6] 0 0
Baseline and Months 1, 3, 6, 9 and 12
Secondary outcome [7] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours
Timepoint [7] 0 0
Baseline and Months 1, 3, 6, 9 and 12
Secondary outcome [8] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours
Timepoint [8] 0 0
Baseline and Months 1, 3, 6, 9 and 12
Secondary outcome [9] 0 0
Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit
Timepoint [9] 0 0
Months 1, 3, 6, 9 and 12
Secondary outcome [10] 0 0
Percentage of Participants With = 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit
Timepoint [10] 0 0
Baseline and Months 1, 3, 6, 9 and 12
Secondary outcome [11] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score
Timepoint [11] 0 0
Baseline and Months 1, 3, 6, 9 and 12
Secondary outcome [12] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score
Timepoint [12] 0 0
Baseline and Months 1, 3, 6, 9 and 12
Secondary outcome [13] 0 0
Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)
Timepoint [13] 0 0
Baseline and Month 12
Secondary outcome [14] 0 0
Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS)
Timepoint [14] 0 0
Baseline and Month 12
Secondary outcome [15] 0 0
Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
Timepoint [15] 0 0
Baseline and Months 3, 6 and 12
Secondary outcome [16] 0 0
Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
Timepoint [16] 0 0
Baseline and Months 3, 6 and 12
Secondary outcome [17] 0 0
Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
Timepoint [17] 0 0
Baseline and Months 3, 6 and 12
Secondary outcome [18] 0 0
Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
Timepoint [18] 0 0
Baseline and Months 3, 6 and 12
Secondary outcome [19] 0 0
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
Timepoint [19] 0 0
Baseline and Month 12
Secondary outcome [20] 0 0
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score
Timepoint [20] 0 0
Baseline and Month 12
Secondary outcome [21] 0 0
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
Timepoint [21] 0 0
Baseline and Month 12
Secondary outcome [22] 0 0
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
Timepoint [22] 0 0
Baseline and Month 12
Secondary outcome [23] 0 0
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
Timepoint [23] 0 0
Baseline and Month 12
Secondary outcome [24] 0 0
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
Timepoint [24] 0 0
Baseline and Months 1, 3, 6, 9 and 12
Secondary outcome [25] 0 0
Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician
Timepoint [25] 0 0
Baseline and Months 3, 6 and 12
Secondary outcome [26] 0 0
Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC)
Timepoint [26] 0 0
Baseline and Month 12
Secondary outcome [27] 0 0
Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram
Timepoint [27] 0 0
From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.

Eligibility
Key inclusion criteria
* Patient is willing and able to complete the micturition diary and questionnaires correctly
* Patient has symptoms of overactive bladder for = 3 months
* Patient experiences frequency of micturition on average = 8 times per 24-hour period during the 3-day micturition diary period
* Patient 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
* Patient 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
* Patient has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
* Patient has an indwelling catheter or practices intermittent self-catheterization
* Patient has diabetic neuropathy
* Patient 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
* Patient receives non-drug treatment including electro-stimulation therapy
* Patient has severe hypertension
* Patient 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
* Patient has been treated with any investigational drug or device within 30 days (90 days in the UK for all clinical studies except 178-CL-046)
* Patient had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period
* Patient has serum creatinine >150 umol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2x upper limit of normal range (ULN), or gamma-glutamyl transpeptidase (?-GT) > 3x ULN
* Patient 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
25/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/05/2010
Sample size
Target
Accrual to date
Final
2792
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
- Woolloongabba
Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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Alaska
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Huddinge
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Sweden
State/province [175] 0 0
Orebro
Country [176] 0 0
Sweden
State/province [176] 0 0
Skovde
Country [177] 0 0
Sweden
State/province [177] 0 0
Sonkoping
Country [178] 0 0
Sweden
State/province [178] 0 0
Stockholm
Country [179] 0 0
Sweden
State/province [179] 0 0
Umea
Country [180] 0 0
Switzerland
State/province [180] 0 0
Frauenfeld
Country [181] 0 0
Switzerland
State/province [181] 0 0
Luzern
Country [182] 0 0
Ukraine
State/province [182] 0 0
Kiev
Country [183] 0 0
United Kingdom
State/province [183] 0 0
Bristol
Country [184] 0 0
United Kingdom
State/province [184] 0 0
Chorley
Country [185] 0 0
United Kingdom
State/province [185] 0 0
Croydon
Country [186] 0 0
United Kingdom
State/province [186] 0 0
Liverpool
Country [187] 0 0
United Kingdom
State/province [187] 0 0
London
Country [188] 0 0
United Kingdom
State/province [188] 0 0
Manchester
Country [189] 0 0
United Kingdom
State/province [189] 0 0
Newcastle Upon Tyne
Country [190] 0 0
United Kingdom
State/province [190] 0 0
Northwood
Country [191] 0 0
United Kingdom
State/province [191] 0 0
Reading
Country [192] 0 0
United Kingdom
State/province [192] 0 0
Sheffield
Country [193] 0 0
United Kingdom
State/province [193] 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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Available to whom?
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicaltrials.astellas.com/transparency/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00688688