Study to Test the Efficacy and Safety of YM178 in Subjects With Symptoms of Overactive Bladder (Blossom)
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ClinicalTrials.gov Identifier: NCT01604928 |
Recruitment Status
:
Completed
First Posted
: May 24, 2012
Last Update Posted
: February 16, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Urinary Bladder, Overactive | Drug: YM178 Drug: tolterodine Drug: Placebo | Phase 2 |
This is a multinational, multicenter, double-blind, double-dummy,
randomized, parallel group, placebo and active controlled phase II proof-of concept study. Patients are enrolled into a single-blind, 2-week placebo run in
period after which they are randomized to 4 weeks of double-blind
treatment with YM178 (low dose and high dose), placebo or tolterodine. Subsequently patients will be followed for an additional 2 weeks
with single-blind placebo treatment. There are 6 visits in total: visit 1 at
enrolment, visit 2 (baseline) after the 2-week placebo run-in, visits 3, 4 and 5
after 1, 2 and 4 weeks of double-blind treatment respectively, and visit 6
after a 2-week follow-up.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 260 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-blind, Parallel Group, Proof of Concept Study of YM178 in Comparison With Placebo and Tolterodine in Patients With Symptomatic Overactive Bladder |
Study Start Date : | April 2004 |
Actual Primary Completion Date : | January 2005 |
Actual Study Completion Date : | January 2005 |

Arm | Intervention/treatment |
---|---|
Experimental: YM178 Dose 1
low dose
|
Drug: YM178
Oral
Other Name: mirabegron
|
Experimental: YM178 Dose 2
high dose
|
Drug: YM178
Oral
Other Name: mirabegron
|
Active Comparator: Tolterodine
Oral
|
Drug: tolterodine
Oral
Other Name: Detrusitol
|
Placebo Comparator: Placebo
Oral
|
Drug: Placebo
Oral
|
- Change from baseline in mean number of micturitions per 24 hours [ Time Frame: Baseline and 4 weeks (end of treatment) ]
- Change from baseline in mean number of urgency episodes/24 hours [ Time Frame: Baseline and 4 weeks (end of treatment) ]
- Change from baseline in mean volume voided per micturition [ Time Frame: Baseline and 4 weeks (end of treatment) ]
- Change from baseline in mean number of urge incontinence episodes/24 hours [ Time Frame: Baseline and 4 weeks (end of treatment) ]
- Change from baseline in mean number of incontinence episodes/24 hours [ Time Frame: Baseline and 4 weeks (end of treatment) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient is willing and able to complete the micturition diary correctly.
- Symptoms of overactive bladder (urinary frequency and urgency with or without incontinence) for ≥ 3 months
At randomization:
- Patient must experience 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
Exclusion Criteria:
- Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practicing an unreliable method of birth control or will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants, contraceptive patches and injectable contraceptives
- Clinically significant outflow obstruction (at the discretion of the investigator)
- Significant post void residual volume (PVR>200ml)
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator (for female patients confirmed by a cough provocation test)
- Patients with a neurological cause for abnormal detrusor activity
- Diabetic neuropathy
- 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
- Uncontrolled narrow angle glaucoma, urinary or gastric retention, colitis ulcerosa, toxic megacolon, myasthenia gravis or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated
- Non-drug treatment including electrostimulation therapy
(a bladder training program or pelvic floor exercises which started more than 1 month prior to entry into the study can be continued)
- Use of medications intended to treat urinary incontinence or listed in Appendix 1 Part A. Part B lists medications that are restricted but accepted under certain conditions
- Known or suspected hypersensitivity to tolterodine, other anticholinergics, ß-adrenoceptor agonists, or lactose or any of the other inactive ingredients
- Any clinically significant cardiovascular complication including CVA, recent myocardial infarction and uncontrolled hypertension, indicated by a sitting systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg
- Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the trial
- Participation in any clinical trial within 30 (90 in the UK) days prior to randomization
- Employees of the sponsor, third parties associated with the study, or the study site
At randomization:
- Patient who did not complete the micturition diary according to the instructions
- Average total daily urine volume > 3000 ml as recorded in the micturition diary
- Clinically significant elevation of serum creatinine or liver enzymes as evidenced by creatinine >150 mmol/L, ASAT or ALAT > 2x upper limit of normal range (ULN), γ-GT > 3x ULN and/or abnormal serum total bilirubin (as assessed in visit 1 samples or alternative sampling within 4 weeks prior to visit 1)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604928
Belgium | |
Site: 12 | |
Brussels, Belgium, 1090 | |
Site: 13 | |
Edegem, Belgium, 2650 | |
Site: 11 | |
Gent, Belgium, 9000 | |
Site: 10 | |
Leuven, Belgium, 3000 | |
Czech Republic | |
Site: 25 | |
Melnik, Czech Republic, 276 01 | |
Site: 22 | |
Prague, Czech Republic, 128 08 | |
Site: 24 | |
Prague, Czech Republic, 140 59 | |
Site: 20 | |
Prague, Czech Republic, 180 81 | |
Site: 21 | |
Usti nad Labem, Czech Republic, 40001 | |
Site: 23 | |
Usti nad Labem, Czech Republic, 401 13 | |
Germany | |
Site: 32 | |
Bad Ems, Germany, 56130 | |
Site: 30 | |
Emmendingen, Germany, 79312 | |
Site: 35 | |
Frankfurt, Germany, 60326 | |
Site: 34 | |
Hagenow, Germany, 19230 | |
Site: 33 | |
Hamburg, Germany, 20253 | |
Site: 36 | |
Koblenz, Germany, 56068 | |
Site: 31 | |
Trier, Germany, 54290 | |
Spain | |
Site: 42 | |
Alzira-Valencia, Spain, 46600 | |
Site: 40 | |
Madrid, Spain, 28046 | |
Site: 43 | |
Miranda de Ebro, Spain, 09200 | |
Sweden | |
Site: 55 | |
Gotenburg, Sweden, 413 45 | |
Site: 53 | |
Linkoping, Sweden, 582 24 | |
Site: 50 | |
Lund, Sweden, 221 85 | |
Site: 51 | |
Stockholm, Sweden, 141 86 | |
Site: 52 | |
Uppsala, Sweden, 751 85 | |
United Kingdom | |
Site: 64 | |
Bimingham, United Kingdom, B15 2TG | |
Site: 62 | |
London, United Kingdom, N19 5LW | |
Site: 63 | |
London, United Kingdom, W1P 7PN | |
Site: 60 | |
Sheffield, United Kingdom, S10 2JF | |
Site: 61 | |
Swansea, United Kingdom, SA6 6NL |
Study Director: | Clinical Study Manager | Astellas Pharma Europe B.V. |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Astellas Pharma Europe B.V. |
ClinicalTrials.gov Identifier: | NCT01604928 History of Changes |
Other Study ID Numbers: |
178-CL-008 |
First Posted: | May 24, 2012 Key Record Dates |
Last Update Posted: | February 16, 2017 |
Last Verified: | February 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com. |
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
Overactive Bladder YM178 Mirabegron Frequency |
Urinary urge incontinence Urgency Urinary incontinence Micturition |
Additional relevant MeSH terms:
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Signs and Symptoms Mirabegron Tolterodine Tartrate Adrenergic beta-3 Receptor Agonists Adrenergic beta-Agonists |
Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |