A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder

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Novartis

Status and phase

Completed
Phase 3

Conditions

Overactive Bladder Syndrome

Treatments

Drug: Darifenacin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00170755
CDAR328A2301

Details and patient eligibility

About

This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.

Enrollment

718 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients with overactive bladder who completed a previous darifenacin short-term trial.
  • Patients capable of independent toileting and able of independently completing the patient diary.

Exclusion criteria

  • Patients in whom the use of anticholinergic drugs was contraindicated
  • Evidence of severe liver disease
  • Patients with other clinically significant urinary or gynecological conditions

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

718 participants in 1 patient group

1
Experimental group
Description:
Darifenacin
Treatment:
Drug: Darifenacin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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