A Randomized, Double-Blind, Parallel-Group, Placebo- and ... | EligiMed

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

CompletadoFase 3ClinicalTrials.gov

ID: NCT01972841Tipo: INTERVENTIONALInicio: 5 de nov de 2013Fin estimado: 22 de oct de 2015

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

Subject had significant PVR volume (\> 150 mL);
Subject had 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 could be inferred when autonomic functions were affected, including heart rate, blood pressure, perspiration and digestion.
Subject had an indwelling catheter or practices intermittent self catheterization.
Subject had chronic inflammation such as bladder pain syndrome /interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis.
Subject had received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
Subject had moderate to severe hepatic impairment
Subject had severe renal impairment
Subject had a clinically significant abnormal ECG
Subject had a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
Subject had 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 had severe hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.

Intervenciones

drug

Solifenacin succinate

Oral tablet

drug

Mirabegron

Oral tablet

drug

Placebo to match solifenacin succinate

Oral tablet

drug

Placebo to match mirabegron

Oral tablet

Ubicaciones

Site AR54005 IUBA - Instituto Urologico de Buenos Aires

Buenos Aires, Argentina

Site AR54003 Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Site AR54006 Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Site AR54001 CDU - Centro de Urología

Ciudad Autónoma Buenos Aires, Argentina

Site AR54004 Instituto de Investigaciones Clnicas Rosario

Rosario Provincia de Santa Fe, Argentina

Patrocinadores

PrincipalAstellas Pharma Europe B.V.

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