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

NCT00171184 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2017-05-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Darifenacin

Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily

DRUG

Placebo

Placebo tablet once daily with sham titration

Sponsors & Collaborators

  • Procter and Gamble

    collaborator INDUSTRY
  • Novartis

    lead INDUSTRY

Principal Investigators

  • Novartis · East Hanover NJ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Completion
2006-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00171184 on ClinicalTrials.gov