Study Details

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Open-label Phase 3 Study with Mirabegron in Children From 3 to Less Than 18 Years of Age with Neurogenic Detrusor Overactivity

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT02751931

Astellas Study ID

The unique identification code given by the study sponsor.

178-CL-206A

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2015-002876-25

Follow Trial

Condition

Bladder Disease

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

3 years - 17 years

Sex

Female & Male

Product

mirabegron + solifenacin succinate

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Jun 2016 - May 2019

Masking

None (Open Label)

Enrollment number

91

An Open-label, Baseline-controlled, Multicenter, Phase 3 Dose-titration Study Followed by a Fixed-dose Observation Period to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Children and Adolescents From 3 to Less Than 18 Years of Age with Neurogenic Detrusor Overactivity (NDO) on Clean Intermittent Catheterization (CIC)

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Site LV37101

Riga, Latvia, LV-1004

Site DK45001

Aarhus N, Denmark, DK-8200

Site TR90005

Ankara, Turkey, 06100

Site LT37002

Kaunas, Lithuania, LT-50009

Site TR90006

Bursa, Turkey

Site PL48001

Gdansk, Poland, 80803

Site RO40002

Bucuresti, Romania, 021495

Site KR82001

Seoul, Republic of Korea, 03722

Site PH63001

Quezon City, Philippines, 1100

Site CO57002

Cali, Colombia, 760032

Site JO96201

Irbid, Jordan, 22110

Site BE32002

Gent, Belgium, 9000

Site HR38503

Zagreb, Croatia, 10000

Site NO47001

Bergen, Norway, 5021

Site TW88602

Taipei, Taiwan, Province of China, 10002

Site SK42101

Bratislava, Slovakia, 83301

Site PL48003

Gdansk, Poland, 80-952

Site RS38102

Nis, Serbia

Site AU61001

Park Ville VIC, Australia, 3052

Site MY60002

Kuala Lumpur, Malaysia, 50586

Site BE32004

Edegem, Belgium, B-2650

Site MX52002

Mexico City, Mexico, 06700

Site PL48002

Warszawa, Poland, 04-730

Site TW88601

New Taipei City, Taiwan, Province of China, 23142

Site KR82002

Seoul, Republic of Korea, 110744

Site RO40001

Bucuresti, Romania, 22328

Site AU61002

Randwick, Australia, 2031

Site SK42102

Martin, Slovakia, 036 59

Site HR38501

Zagreb, Croatia, 10000

Site BE32001

Gent, Belgium, 9000

Site DK45002

Copenhagen, Denmark, 2100

Site IL97202

Jerusalem, Israel, 91090

Site MY60001

Georgetown, Malaysia, 10990

Site TR90008

Mersin, Turkey, 33343

Site TR90002

Ankara, Turkey, 06100

Site RS38101

Novi Sad, Serbia, 21000

Site LT37001

Vilnius, Lithuania, LT-08406

Site JO96202

Amman, Jordan, 11183

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