A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients

Astellas

Status and phase: Completed; Phase 3

Conditions: Urinary Bladder, Overactive

Treatments: Drug: tolterodine; Drug: solifenacin succinate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00368706

90506/CHoTD01

Details and patient eligibility

About

To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg, bid

Enrollment: 246 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients willing and able to complete the micturition diary correctly
• Patients experiencing frequency of micturition as verified in the diary
• Patients experiencing significant post void residual volume
• OAB symptoms including urinary frequency, urgency or urge incontinence for 3 months or more.

Exclusion criteria

• Significant post void residual volume
• Patients with indwelling catheters or practicing intermittent self- catheterization
• Known or suspected hypersensitivity to solifenacin succinate or other anticholinergics or lactose

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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246 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: solifenacin succinate

2

Active Comparator group

Treatment:

Drug: tolterodine