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A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine

NCT01302067 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2012

Last updated 2014-03-26

Study results available
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Summary

This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. The study also assesses the side effects and safety of the two doses.

Conditions

Interventions

DRUG

Fesoterodine 8mg

Oral, 1 tablet per day, 12 weeks duration, 8mg/day

DRUG

Fesoterodine 4mg

Oral, 1 tablet per day, 12 weeks duration, 4mg/day

DRUG

Placebo

Oral, 1 tablet per day, 12 weeks duration

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States
  • Argentina
  • Canada
  • Chile
  • Colombia
  • Czechia
  • Denmark
  • Egypt
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Lithuania
  • Mexico
  • Norway
  • Philippines
  • Poland
  • Russia
  • Slovakia
  • South Africa
  • South Korea
  • Sweden
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01302067 on ClinicalTrials.gov