A Proof-of-Concept Study: Mirabegron, a New Therapy for Overactive Bladder

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064190%3A_____%2F13%3A%230000711" target="_blank" >RIV/00064190:_____/13:#0000711 - isvavai.cz</a>
Result on the web
<a href="http://dx.doi.org/10.1002/nau.22373" target="_blank" >http://dx.doi.org/10.1002/nau.22373</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1002/nau.22373" target="_blank" >10.1002/nau.22373</a>

Result language
angličtina
Original language name
A Proof-of-Concept Study: Mirabegron, a New Therapy for Overactive Bladder
Original language description
AimsTo evaluate the potential of mirabegron, a selective 3-adrenoceptor agonist, for treatment of overactive bladder (OAB) symptoms. MethodsA multicenter, randomized, double-blind, double-dummy, parallel group, placebo and active-controlled, Phase 2, proof-of-concept study was conducted. Eligible patients (n=314) were enrolled into a single-blind, 2-week placebo run-in period followed by a randomized, double-blind, placebo-controlled treatment period. Patients received mirabegron 100 or 150mg twice-daily (BID), placebo or tolterodine 4mg extended release (ER) once-daily for 4 weeks. Primary endpoint was change from baseline to end-of-treatment in mean number of micturition episodes per 24hr. Secondary endpoints included changes in mean volume voided per micturition; mean number of urinary incontinence, urgency urinary incontinence, and urgency episodes per 24hr; severity of urgency; nocturia, and quality of life measures. Safety parameters included adverse events, laboratory tests, ele
Czech name
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Czech description
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Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FP - Other medical fields
OECD FORD branch
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Publication year
2013
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

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