Clinical trial NCT01638000 (phase 3, status: completed)
Conditions: urologic diseases, urinary bladder, overactive, urinary bladder diseases
ICD codes: N32.81, Q64.10, Q64.11, Q64.12, Q64.19
Drugs: mirabegron, solifenacin succinate
SMILES: NC1=NC(CC(=O)NC2=CC=C(CCNC[C@H](O)C3=CC=CC=C3)C=C2)=CS1, O=C(O[C@H]1CN2CCC1CC2)N1CCC2=CC=CC=C2[C@@H]1C1=CC=CC=C1
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