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Single-dose study to assess pharmacokinetics of solifenacin succinate suspension in children and adolescents

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.
NCT01262391

Astellas Study ID

The unique identification code given by the study sponsor.

905-CL-075

EudraCT ID

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

2009-017197-21

Follow Trial

Condition

Overactive Bladder Disease

Phase

These clinical trials are usually the first time an experimental treatment is studied in a small group of people.

Phase 1

Age

5 years - 17 years

Sex

Female & Male

Product

N/A

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

Oct 2010 - Aug 2011

Masking

None (Open Label)

Enrollment number

42

A multicenter, open-label, single ascending dose study to evaluate pharmacokinetics, safety and tolerability of solifenacin succinate suspension in pediatric patients aged 5 to 17 years (inclusive) with Overactive Bladder (OAB)

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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