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Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over

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Novartis

Status and phase

Completed
Phase 2

Conditions

Healthy Volunteers

Treatments

Drug: Placebo
Drug: Darifenacin
Drug: Oxybutynin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00170768
CDAR328A2403

Details and patient eligibility

About

The purpose of this study is to explore the possible cognitive effects of darifenacin modified release and long-acting oxybutynin.

Enrollment

150 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Males and females aged 60 and over
  • United States English as a primary language
  • Given written informed consent by signing and dating an informed consent form prior to study entry

Exclusion criteria

  • Current diseases in which the use of anti-cholinergic drugs is contraindicated, including the use of drugs with anti-cholinergic effects
  • Volunteers with history of urinary retention or current bladder outlet obstruction, as determined by the investigator

Other protocol defined inclusion/exclusion criteria may apply.

  • Current use of drugs known to effect memory and cognition Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

150 participants in 3 patient groups, including a placebo group

1
Experimental group
Description:
Darifenacin
Treatment:
Drug: Darifenacin
2
Active Comparator group
Description:
Oxybutynin
Treatment:
Drug: Oxybutynin
3
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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