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

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)

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718 participants in 1 patient group

1

Experimental group

Description:

Darifenacin

Treatment:

Drug: Darifenacin