Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006401

Trial Description

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Title

A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder

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Trial Acronym

SYNERGY

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to examine how well two medicines (solifenacin succinate and
mirabegron) combined work compared to each medicine alone in the treatment of bladder
problems.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006401
  •   2014/11/28
  •   2013/10/25
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   U1111-1153-9095 
  •   2012-005735-91 
  •   NCT01972841  (ClinicalTrials.gov)
  •   178-CL-101  (Astellas Pharma Europe B.V.)
  •   2012-005735-91 
  •   U1111-1153-9095 
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Health Condition or Problem studied

  •   Overactive Bladder
  •   Urgency Incontinence
  •   Urinary Bladder Overactive
  •   Urinary Bladder Diseases\Urologic Diseases
  •   N32.8 -  Other specified disorders of bladder
  •   R32 -  Unspecified urinary incontinence
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Interventions/Observational Groups

  •   Drug: Solifenacin Succinate
  •   Drug: Mirabegron
  •   Drug: Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo, Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Change from baseline in mean number of incontinence episodes per 24 hours at End of Treatment (EoT); time frame: Baseline & 12 weeks
- Change from baseline in mean number of micturitions per 24 hours at EoT; time frame: Baseline & 12 weeks

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Secondary Outcome

- Change from baseline in mean volume voided per micturition at EoT; time frame: Baseline & 12 weeks
- Change from baseline in Symptom Bother as assessed by Overactive Bladder Questionnaire (OAB-q) at EoT; time frame: Baseline & 12 weeks
- Change from baseline in Subject assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS) at EoT; time frame: Baseline & 12 weeks
- Number of incontinence episodes during the 7-day observation period prior to week 4, 8, 12 and EoT and changes from baseline; time frame: Baseline & 12 weeks
- Change from baseline in mean number of incontinence episodes per 24 hours at secondary time points (after 4, 8 and 12 weeks of treatment); time frame: Baseline & 12 weeks
- Change from baseline in mean number of micturitions per 24 hours at secondary time points (after 4, 8 and 12 weeks of treatment); time frame: Baseline & 12 weeks
- Change from baseline in mean volume voided at secondary time points (after 4, 8 and 12 weeks of treatment); time frame: Baseline & 12 weeks
- Number of urgency incontinence episodes during the 7-day observation period prior to week 4, 8, 12 and EoT and changes from baseline; time frame: Baseline & 12 weeks
- Change from baseline in mean number of urgency incontinence episodes per 24 hours (Week 4, 8, 12, and EoT); time frame: Baseline & 12 weeks
- Change from baseline in mean number of urgency episodes (grade 3 and/or 4)/24 hours (PPIUS scale) (Week 4, 8, 12, and EoT); time frame: Baseline & 12 weeks
- Number of nocturia episodes during the 7-day observation period prior to Week 4, 8, 12, and EoT and changes from baseline; time frame: Baseline & 12 weeks
- Change from baseline in mean number of nocturia episodes per 24 hours(Week 4, 8, 12, and EoT); time frame: Baseline & 12 weeks
- Number of pads used during the 7-day observation period prior to Week 4, 8, 12, and EoT and changes from baseline; time frame: Baseline & 12 weeks
- Change from baseline in mean number of pads used per 24 hours (Week 4, 8, 12, and EoT); time frame: Baseline & 12 weeks
- Number of incontinence-free days during the 7-day diary period (Week 4, 8, 12, and EoT); time frame: 12 weeks
- Number of days with less than 8 micturitions during the 7-day diary period (Week 4, 8, 12, and EoT); time frame: 12 weeks
- Number of incontinence-free days with less than 8 micturitions per day during the 7-day diary period (Week 4, 8, 12, and EoT); time frame: 12 weeks

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Australia
  •   Belgium
  •   Bulgaria
  •   Canada
  •   China
  •   Colombia
  •   Czech Republic
  •   Denmark
  •   Estonia
  •   Finland
  •   France
  •   Germany
  •   Greece
  •   Hong Kong
  •   Hungary
  •   Italy
  •   Korea, Republic of
  •   Latvia
  •   Lithuania
  •   Malaysia
  •   Mexico
  •   Netherlands
  •   New Zealand
  •   Norway
  •   Peru
  •   Philippines
  •   Poland
  •   Romania
  •   Russian Federation
  •   Singapore
  •   Slovakia
  •   Slovenia
  •   South Africa
  •   Spain
  •   Sweden
  •   Taiwan, Province of China
  •   Thailand
  •   Turkey
  •   Ukraine
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2013/11/30
  •   3392
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Subject is willing and able to complete the micturition diary and questionnaires
correctly and able to measure his/her vital signs at home at stipulated time points,
using the device provided by the study personnel, and to adequately record the
readings;

- Subject has symptoms of "wet" OAB (urinary frequency and urgency with incontinence)
for at least 3 months;

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Exclusion Criteria

- Subject has significant PVR volume (> 150 mL);

- Subject has a neurological cause for detrusor overactivity (e.g. neurogenic bladder,
diabetic neuropathy with autonomic component or bladder involvement, or systemic or
central neurological disease such as multiple sclerosis and Parkinson's disease with
autonomic component or bladder involvement). An autonomic component can be inferred
when autonomic functions are affected, including heart rate, blood pressure,
perspiration and digestion.

- Subject has an indwelling catheter or practices intermittent self catheterization.

- Subject has chronic inflammation such as bladder pain syndrome /interstitial
cystitis, symptomatic bladder stones or any previous or current radiation cystitis.

- Subject has received intravesical treatment in the past 12 months with e.g.,
botulinum toxin, resiniferatoxin, capsaicin.

- Subject has moderate to severe hepatic impairment

- Subject has severe renal impairment

- Subject has a clinically significant abnormal ECG

- Subject has a concurrent malignancy or history of cancer (except noninvasive skin
cancer) within the last 5 years prior to screening.

- Subject has an average QTcF interval > 450 ms for males or > 470 ms for females based
on the triplicate ECGs completed at Screening or is at risk of QT prolongation (e.g.,
family history of long QT syndrome, hypokalaemia).

- Subject has severe hypertension, which is defined as a sitting average systolic blood
pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Astellas Pharma Europe B.V.
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    •   [---]*
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    • Astellas Pharma Europe B.V.
    • Medical Director 
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    • Astellas Pharma Europe B.V.
    • Medical Director 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2015/10/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.