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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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