Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder

Novartis

Status and phase: Completed; Phase 4

Conditions: Overactive Bladder

Treatments: Drug: Placebo; Drug: Darifenacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00171184

CDAR328A2409

Details and patient eligibility

About

The objective of this study is to assess the efficacy, safety and tolerability of 12-weeks treatment with darifenacin in patients aged >Ý 65 years with OAB.

Enrollment: 400 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptoms of OAB for at least six months prior to Visit 3
• Symptoms of OAB during the 7 day diary period immediately preceding Visit 3:
• ≥ 1 UUIE on average per day and
• ≥ 10 episodes of micturition on average per day

Exclusion criteria

• A total daily urinary volume > 3000 ml or a mean volume voided per micturition of > 300 ml as verified in the micturition diary before randomization
• Post-void residual (PVR) urinary volume > 100 ml
• Clinically significant stress urinary incontinence as determined by the investigator
• Clinically significant bladder outlet obstruction as determined by the investigator
• Concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh B and C), severe ulcerative colitis, toxic megacolon.

Other protocol inclusion / exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Darifenacin

Treatment:

Drug: Darifenacin

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo