Trial record 1 of 1 for:
A0221006
Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00658684 |
Recruitment Status :
Completed
First Posted : April 15, 2008
Results First Posted : August 11, 2010
Last Update Posted : October 13, 2010
|
Sponsor:
Pfizer
Information provided by:
Pfizer
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Overactive Bladder |
Intervention |
Drug: fesoterodine fumarate |
Enrollment | 153 |
Participant Flow
Recruitment Details | Subjects were screened at 12 centers in Japan. |
Pre-assignment Details | After screening, eligible subjects entered a run-in phase during which they completed a 3-day micturition diary for 3 consecutive days in 7 days prior to Baseline visit. At Baseline visit, the diary data and screening laboratory data were checked against the entry criteria to identify subjects eligible for study participation. |
Arm/Group Title | Total | 4 mg | 4 mg > 8 mg > 4 mg | 4 mg > 8 mg |
---|---|---|---|---|
Arm/Group Description | All subjects | Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg) | Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg) | Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained) |
Period Title: Overall Study | ||||
Started | 152 | 99 | 25 | 28 |
Completed | 133 | 84 | 22 | 27 |
Not Completed | 19 | 15 | 3 | 1 |
Reason Not Completed | ||||
Adverse Event | 10 | 8 | 2 | 0 |
Withdrawal by Subject | 6 | 4 | 1 | 1 |
Lack of Efficacy | 1 | 1 | 0 | 0 |
Protocol Violation | 1 | 1 | 0 | 0 |
Pregnancy | 1 | 1 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | 4 mg | 4 mg > 8 mg > 4 mg | 4 mg > 8 mg | Total | |
---|---|---|---|---|---|
Arm/Group Description | Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg) | Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg) | Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained) | Total of all reporting groups | |
Overall Number of Baseline Participants | 99 | 25 | 28 | 152 | |
Baseline Analysis Population Description |
[Not Specified]
|
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 99 participants | 25 participants | 28 participants | 152 participants | |
51.0 (13.1) | 54.7 (10.5) | 57.0 (11.7) | 52.7 (12.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 99 participants | 25 participants | 28 participants | 152 participants | |
Female |
88 88.9%
|
21 84.0%
|
24 85.7%
|
133 87.5%
|
|
Male |
11 11.1%
|
4 16.0%
|
4 14.3%
|
19 12.5%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer, Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov Identifier: | NCT00658684 |
Other Study ID Numbers: |
A0221006 A0221006 |
First Submitted: | April 9, 2008 |
First Posted: | April 15, 2008 |
Results First Submitted: | July 14, 2010 |
Results First Posted: | August 11, 2010 |
Last Update Posted: | October 13, 2010 |