Trial · NCT02526979
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron Oral Suspension in Pediatric Subjects From 3 to Less Than 12 Years of Age With Neurogenic Detrusor Overactivity (NDO) or Overactive Bladder (OAB)
NCT02526979, Phase 1, Completed, Astellas Pharma Europe B.V.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron Oral Suspension in Pediatric Subjects From 3 to Less Than 12 Years of Age With Neurogenic Detrusor Overactivity (NDO) or Overactive Bladder (OAB). Trials, record NCT02526979. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02526979
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron Oral Suspension in Pediatric Subjects From 3 to Less Than 12 Years of Age With Neurogenic Detrusor Overactivity (NDO) or Overactive Bladder (OAB)
- NCT number
- NCT02526979
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 9 participants, actual
- Lead sponsor
- Astellas Pharma Europe B.V.
- Conditions
- Overactive Bladder, Neurogenic Detrusor Overactivity
- Interventions
- mirabegron
- First posted
- 2015-08-18
- Last updated
- 2024-10-31
- Other registries' IDs
- eudract:2015-000700-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacokinetics of mirabegron in plasma: Cmax | Days 1 - 7 | Maximum concentration (Cmax) |
| Primary | Pharmacokinetics of mirabegron in plasma: AUCinf | Days 1 - 7 | Area under the curve from time zero to infinity (AUCinf) |
| Primary | Pharmacokinetics of mirabegron in plasma: tmax | Days 1 - 7 | The time after dosing when Cmax occurs (tmax) |
| Primary | Pharmacokinetics of mirabegron in plasma: t1/2 | Days 1 - 7 | Apparent Terminal Elimination Half-life (t1/2) |
| Secondary | Safety profile as assessed by adverse events, clinical laboratory evaluations, vital signs and electrocardiograms (ECG) | Up to Day 7 | Clinical laboratory evaluations include hematology, biochemistry and urinalysis. |
| Secondary | Safety as assessed by post-void residual volume (PVR) | Day 1 | |
| Secondary | Acceptability and Palatability as assessed by taste and acceptance of the suspension (5-point scale) | Day 1 | 5-point scale consists of 3 questions ranging in score from 0=Really Bad to 4=Really Good. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02526979
GET https://conductscience.org/api/trials/v1/NCT02526979/registered