Trial · NCT04641975
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 12/EoT in Mean Number of Micturitions Per 24 Hours for Age Group 5 to <12 Years | Baseline, week 12 | Full Analysis set: All participants who were randomized and received at least 1 dose of study drug and had at least 1 post baseline measurement for mean number of micturitions per 24 hours. | micturitions per 24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 12/EoT in Mean Volume Voided Per 24 Hours for Age Group 5 to <12 Years | Baseline, week 12 | Full Analysis Set with available data was analyzed. | milliliter (mL)/24 hours | MEAN |
| SECONDARY | Change From Baseline to Week 12/EoT in Maximum Volume Voided (MVV) for Age Group 5 to <12 Years | Baseline, week 12 | Full Analysis Set with available data was analyzed. | mL | MEAN |
| SECONDARY | Change From Baseline to Week 12/EoT in Mean Number of Daytime Incontinence Episodes Per 24 Hours for Age Group 5 to <12 Years | Baseline, week 12 | Full Analysis Set with available data was analyzed. | incontinence episodes per 24 hours | MEAN |
| SECONDARY | Change From Baseline to Week 12/EoT in Mean Number of Nighttime Incontinence Episodes Per 24 Hours for Age Group 5 to <12 Years | Baseline, week 12 | Full Analysis Set. | incontinence episodes per 24 hours | MEAN |
| SECONDARY | Change From Baseline to Week 12/EoT in Mean Number of Daytime Micturitions Per 24 Hours for Age Group 5 to <12 Years | Baseline, week 12 | Full Analysis Set | micturitions per 24 hours | MEAN |
| SECONDARY | Change From Baseline to Week 12/EoT in Number of Dry (Incontinence-free) Days Per 7 Days for Age Group 5 to <12 Years | Baseline, week 12 | Full Analysis Set with available data was analyzed. | incontinence-free days | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | From first dose up to week 14 | SAF | Participants | NUMBER |
| SECONDARY | Change From Baseline in Post Void Residual (PVR) Volume | Baseline, weeks 4, 12, 14 | SAF with available data was analyzed. | mL | MEAN |
| SECONDARY | Number of Participants With Study Drug Acceptability and Palatability for Tablets | Week 12 | SAF with available data was analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants With Study Drug Acceptability and Palatability for Oral Suspension | Week 12 | SAF with available data was analyzed. | Participants | NUMBER |
| SECONDARY | Pharmacokinetic (PK) of Mirabegron in Plasma: Maximum Concentration (Cmax) | Predose (1 hour prior) at weeks 4 and 12 | PK parameter calculation was not possible due to low number of samples collected. | ||
| SECONDARY | PK of Mirabegron in Plasma: Time of the Maximum Concentration (Tmax) | Predose (1 hour prior) at weeks 4 and 12 | PK parameter calculation was not possible due to low number of samples collected. | ||
| SECONDARY | PK of Mirabegron in Plasma: Area Under Concentration-time Curve Over Dosing Interval (AUCtau) | Predose (1 hour prior) at weeks 4 and 12 | PK parameter calculation was not possible due to low number of samples collected. | ||
| SECONDARY | PK of Mirabegron in Plasma: Concentration Immediately Prior to Dosing (Ctrough) | Predose (1 hour prior) at weeks 4 and 12 | Pharmacokinetics Analysis Set included all participants who took at least 1 dose of study drug and contributed at least one pharmacokinetic sample in which the date and time of the sample and prior dose were known. | ng/mL | MEAN |
| SECONDARY | PK of Mirabegron in Plasma: Apparent Total Clearance (CL/F) | Predose (1 hour prior) at weeks 4 and 12 | PK parameter calculation was not possible due to low number of samples collected. | ||
| SECONDARY | PK of Mirabegron in Plasma: Apparent Volume of Distribution (Vz/F) | Predose (1 hour prior) at weeks 4 and 12 | PK parameter calculation was not possible due to low number of samples collected. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT04641975/outcomes