A Study to Assess the Cognitive Effects of Fesoterodine in Elderly Subjects

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01161472

First received: July 12, 2010

Last updated: May 25, 2012

Last verified: May 2012

History of Changes

Results First Received: May 25, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Condition:	Healthy
Interventions:	Drug: 4mg fesoterodine Drug: 8mg fesoterodine Drug: alprazolam 1mg Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg	Fesoterodine 4 milligram (mg) tablet administered orally once daily (OD) for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo	Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; then fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg	Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg	Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.

Participant Flow for 7 periods

Period 1: First Intervention Period

	Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg	Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo	Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg	Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg
STARTED	5	5	5	5
Treated	5	5	5	5
COMPLETED	5	5	5	5
NOT COMPLETED	0	0	0	0

Period 2: Washout Period (At Least 3 to 6 Days)

	Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg	Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo	Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg	Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg
STARTED	5	5	5	5
COMPLETED	5	5	5	5
NOT COMPLETED	0	0	0	0

Period 3: Second Intervention Period

	Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg	Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo	Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg	Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg
STARTED	5	5	5	5
COMPLETED	5	5	5	5
NOT COMPLETED	0	0	0	0

Period 4: Washout Period (At Least 3 to 6 Days)

	Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg	Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo	Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg	Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg
STARTED	5	5	5	5
COMPLETED	4	5	5	5
NOT COMPLETED	1	0	0	0
Withdrawal by Subject	1	0	0	0

Period 5: Third Intervention Period

	Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg	Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo	Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg	Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg
STARTED	4	5	5	5
COMPLETED	4	5	5	5
NOT COMPLETED	0	0	0	0

Period 6: Washout Period (At Least 3 to 6 Days)

	Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg	Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo	Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg	Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg
STARTED	4	5	5	5
COMPLETED	4	5	5	5
NOT COMPLETED	0	0	0	0

Period 7: Fourth Intervention Period

	Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg	Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo	Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg	Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg
STARTED	4	5	5	5
COMPLETED	4	5	5	5
NOT COMPLETED	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Entire Study Population	All participants randomized to any treatment (fesoterodine 4 mg tablet first, fesoterodine 8 mg tablet first, alprazolam 1 mg capsule first and placebo first).

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	20
Age [units: Years] Mean ± Standard Deviation	72.2 ± 5.2
Gender [units: Participants]
Female	8
Male	12

Outcome Measures

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1. Primary:

Computer Based Objective Cognition Testing (CogState) Detection Speed [ Time Frame: Baseline ]

Measure Type	Primary
Measure Title	Computer Based Objective Cognition Testing (CogState) Detection Speed
Measure Description	Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (MS)]. Lower scores meant a better performance.
Time Frame	Baseline
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Per Protocol (PP) Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.

Reporting Groups

	Description
Fesoterodine 4 mg	Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Fesoterodine 8 mg	Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Aplrazolam 1 mg	Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Placebo	Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.

Measured Values

	Fesoterodine 4 mg	Fesoterodine 8 mg	Aplrazolam 1 mg	Placebo
Number of Participants Analyzed [units: participants]	18	18	18	18
Computer Based Objective Cognition Testing (CogState) Detection Speed [units: Log10 MS] Mean ± Standard Deviation	2.6333 ± 0.1049	2.5971 ± 0.0937	2.6103 ± 0.1107	2.5842 ± 0.0875

No statistical analysis provided for Computer Based Objective Cognition Testing (CogState) Detection Speed

2. Primary:

Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6 [ Time Frame: Baseline and Day 6 ]

Measure Type	Primary
Measure Title	Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6
Measure Description	Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (MS)]. Lower scores meant a better performance.
Time Frame	Baseline and Day 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.

Reporting Groups

	Description
Fesoterodine 4 mg	Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Fesoterodine 8 mg	Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Aplrazolam 1 mg	Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Placebo	Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.

Measured Values

	Fesoterodine 4 mg	Fesoterodine 8 mg	Aplrazolam 1 mg	Placebo
Number of Participants Analyzed [units: participants]	18	18	18	18
Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6 [units: Log10 MS] Least Squares Mean ± Standard Error	-0.0201 ± 0.0153	-0.0119 ± 0.0150	0.0684 ± 0.0150	0.0084 ± 0.0152

Statistical Analysis 1 for Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6

Groups ^[1]	Fesoterodine 4 mg vs. Placebo
Method ^[2]	ANCOVA
P Value ^[3]	0.1198
Least square (LS) Mean Difference ^[4]	-0.0285
Standard Error of the mean	± 0.0180
95% Confidence Interval	( -0.0647 to 0.0077 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis of Covariance (ANCOVA) was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6

Groups ^[1]	Fesoterodine 8 mg vs. Placebo
Method ^[2]	ANCOVA
P Value ^[3]	0.2459
LS Mean Difference ^[4]	-0.0203
Standard Error of the mean	± 0.0173
95% Confidence Interval	( -0.0551 to 0.0145 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

3. Secondary:

CogState Identification Speed [ Time Frame: Baseline ]

Measure Type	Secondary
Measure Title	CogState Identification Speed
Measure Description	Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 MS). Lower scores meant a better performance.
Time Frame	Baseline
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.

Reporting Groups

	Description
Fesoterodine 4 mg	Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Fesoterodine 8 mg	Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Aplrazolam 1 mg	Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Placebo	Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.

Measured Values

	Fesoterodine 4 mg	Fesoterodine 8 mg	Aplrazolam 1 mg	Placebo
Number of Participants Analyzed [units: participants]	18	18	18	18
CogState Identification Speed [units: Log10 MS] Mean ± Standard Deviation	2.7540 ± 0.0505	2.7672 ± 0.0610	2.7577 ± 0.0577	2.7457 ± 0.0637

No statistical analysis provided for CogState Identification Speed

4. Secondary:

Change From Baseline in CogState Identification Speed on Day 6 [ Time Frame: Baseline and Day 6 ]

Measure Type	Secondary
Measure Title	Change From Baseline in CogState Identification Speed on Day 6
Measure Description	Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 MS). Lower scores meant a better performance.
Time Frame	Baseline and Day 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.

Reporting Groups

	Description
Fesoterodine 4 mg	Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Fesoterodine 8 mg	Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Aplrazolam 1 mg	Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Placebo	Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.

Measured Values

	Fesoterodine 4 mg	Fesoterodine 8 mg	Aplrazolam 1 mg	Placebo
Number of Participants Analyzed [units: participants]	18	18	18	18
Change From Baseline in CogState Identification Speed on Day 6 [units: Log10 MS] Least Squares Mean ± Standard Error	0.0105 ± 0.0084	0.0057 ± 0.0085	0.0817 ± 0.0084	0.0142 ± 0.0085

Statistical Analysis 1 for Change From Baseline in CogState Identification Speed on Day 6

Groups ^[1]	Fesoterodine 4 mg vs. Placebo
Method ^[2]	ANCOVA
P Value ^[3]	0.7502
LS Mean Difference ^[4]	-0.0037
Standard Error of the mean	± 0.0115
95% Confidence Interval	( -0.0268 to 0.0194 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline in CogState Identification Speed on Day 6

Groups ^[1]	Fesoterodine 8 mg vs. Placebo
Method ^[2]	ANCOVA
P Value ^[3]	0.4785
LS Mean Difference ^[4]	-0.0085
Standard Error of the mean	± 0.0119
95% Confidence Interval	( -0.0325 to 0.0154 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

5. Secondary:

CogState One Card Learning [ Time Frame: Baseline ]

Measure Type	Secondary
Measure Title	CogState One Card Learning
Measure Description	One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root (sqrt) of the proportion of correct responses. Higher scores meant a better performance.
Time Frame	Baseline
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.

Reporting Groups

	Description
Fesoterodine 4 mg	Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Fesoterodine 8 mg	Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Aplrazolam 1 mg	Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Placebo	Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.

Measured Values

	Fesoterodine 4 mg	Fesoterodine 8 mg	Aplrazolam 1 mg	Placebo
Number of Participants Analyzed [units: participants]	18	18	18	18
CogState One Card Learning [units: Arcsine [(sqrt) proportion correct]] Mean ± Standard Deviation	0.9585 ± 0.0893	0.9421 ± 0.0878	0.9531 ± 0.1062	0.9302 ± 0.0822

No statistical analysis provided for CogState One Card Learning

6. Secondary:

Change From Baseline in CogState One Card Learning on Day 6 [ Time Frame: Baseline and Day 6 ]

Measure Type	Secondary
Measure Title	Change From Baseline in CogState One Card Learning on Day 6
Measure Description	One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root (sqrt) of the proportion of correct responses. Higher scores meant a better performance.
Time Frame	Baseline and Day 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.

Reporting Groups

	Description
Fesoterodine 4 mg	Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Fesoterodine 8 mg	Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Aplrazolam 1 mg	Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Placebo	Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.

Measured Values

	Fesoterodine 4 mg	Fesoterodine 8 mg	Aplrazolam 1 mg	Placebo
Number of Participants Analyzed [units: participants]	18	18	18	18
Change From Baseline in CogState One Card Learning on Day 6 [units: Arcsine [(sqrt) proportion correct]] Least Squares Mean ± Standard Error	-0.0094 ± 0.0204	0.0151 ± 0.0203	-0.0880 ± 0.0204	-0.0058 ± 0.0205

Statistical Analysis 1 for Change From Baseline in CogState One Card Learning on Day 6

Groups ^[1]	Fesoterodine 4 mg vs. Placebo
Method ^[2]	ANCOVA
P Value ^[3]	0.8944
LS Mean Difference ^[4]	-0.0035
Standard Error of the mean	± 0.0265
95% Confidence Interval	( -0.0569 to 0.0498 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline in CogState One Card Learning on Day 6

Groups ^[1]	Fesoterodine 8 mg vs. Placebo
Method ^[2]	ANCOVA
P Value ^[3]	0.4308
LS Mean Difference ^[4]	0.0209
Standard Error of the mean	± 0.0263
95% Confidence Interval	( -0.0320 to 0.0738 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

7. Secondary:

CogState Continuous Paired Associate Learning (CPAL) [ Time Frame: Baseline ]

Measure Type	Secondary
Measure Title	CogState Continuous Paired Associate Learning (CPAL)
Measure Description	CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Lower scores meant a better performance.
Time Frame	Baseline
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.

Reporting Groups

	Description
Fesoterodine 4 mg	Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Fesoterodine 8 mg	Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Aplrazolam 1 mg	Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Placebo	Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.

Measured Values

	Fesoterodine 4 mg	Fesoterodine 8 mg	Aplrazolam 1 mg	Placebo
Number of Participants Analyzed [units: participants]	18	18	18	18
CogState Continuous Paired Associate Learning (CPAL) [units: Errors] Mean ± Standard Deviation	96.33 ± 57.058	99.83 ± 55.343	89.50 ± 58.240	107.44 ± 53.388

No statistical analysis provided for CogState Continuous Paired Associate Learning (CPAL)

8. Secondary:

Change From Baseline in CogState CPAL on Day 6 [ Time Frame: Baseline and Day 6 ]

Measure Type	Secondary
Measure Title	Change From Baseline in CogState CPAL on Day 6
Measure Description	CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Lower scores meant a better performance.
Time Frame	Baseline and Day 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.

Reporting Groups

	Description
Fesoterodine 4 mg	Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Fesoterodine 8 mg	Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Aplrazolam 1 mg	Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Placebo	Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.

Measured Values

	Fesoterodine 4 mg	Fesoterodine 8 mg	Aplrazolam 1 mg	Placebo
Number of Participants Analyzed [units: participants]	18	18	18	18
Change From Baseline in CogState CPAL on Day 6 [units: Errors] Least Squares Mean ± Standard Error	6.7933 ± 9.8653	-16.7905 ± 9.8715	58.2002 ± 10.0337	3.1304 ± 9.9948

Statistical Analysis 1 for Change From Baseline in CogState CPAL on Day 6

Groups ^[1]	Fesoterodine 4 mg vs. Placebo
Method ^[2]	ANCOVA
P Value ^[3]	0.7707
LS Mean Difference ^[4]	3.6629
Standard Error of the mean	± 12.4945
95% Confidence Interval	( -21.4729 to 28.7987 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline in CogState CPAL on Day 6

Groups ^[1]	Fesoterodine 8 mg vs. Placebo
Method ^[2]	ANCOVA
P Value ^[3]	0.1162
LS Mean Difference ^[4]	-19.9210
Standard Error of the mean	± 12.4482
95% Confidence Interval	( -44.9634 to 5.1215 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

9. Secondary:

CogState Groton Maze Learning Task (GMLT) [ Time Frame: Baseline ]

Measure Type	Secondary
Measure Title	CogState Groton Maze Learning Task (GMLT)
Measure Description	GMLT: a cognitive test which assessed executive function. Participant was shown a 10 x 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores meant a better performance.
Time Frame	Baseline
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.

Reporting Groups

	Description
Fesoterodine 4 mg	Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Fesoterodine 8 mg	Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Aplrazolam 1 mg	Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Placebo	Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.

Measured Values

	Fesoterodine 4 mg	Fesoterodine 8 mg	Aplrazolam 1 mg	Placebo
Number of Participants Analyzed [units: participants]	18	18	18	18
CogState Groton Maze Learning Task (GMLT) [units: Errors] Mean ± Standard Deviation	53.72 ± 17.091	58.39 ± 15.170	56.83 ± 15.023	52.28 ± 15.736

No statistical analysis provided for CogState Groton Maze Learning Task (GMLT)

10. Secondary:

Change From Baseline in CogState Groton Maze Learning Task on Day 6 [ Time Frame: Baseline and Day 6 ]

Measure Type	Secondary
Measure Title	Change From Baseline in CogState Groton Maze Learning Task on Day 6
Measure Description	GMLT: a cognitive test which assessed executive function. Participant was shown a 10 x 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores meant a better performance.
Time Frame	Baseline and Day 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.

Reporting Groups

	Description
Fesoterodine 4 mg	Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Fesoterodine 8 mg	Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Aplrazolam 1 mg	Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Placebo	Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.

Measured Values

	Fesoterodine 4 mg	Fesoterodine 8 mg	Aplrazolam 1 mg	Placebo
Number of Participants Analyzed [units: participants]	18	18	18	18
Change From Baseline in CogState Groton Maze Learning Task on Day 6 [units: Errors] Least Squares Mean ± Standard Error	-4.1399 ± 4.2079	-5.7717 ± 4.2515	24.7115 ± 4.2033	-4.1467 ± 4.2413

Statistical Analysis 1 for Change From Baseline in CogState Groton Maze Learning Task on Day 6

Groups ^[1]	Fesoterodine 4 mg vs. Placebo
Method ^[2]	ANCOVA
P Value ^[3]	0.9989
LS Mean Difference ^[4]	0.0068
Standard Error of the mean	± 4.8707
95% Confidence Interval	( -9.8297 to 9.8433 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline in CogState Groton Maze Learning Task on Day 6

Groups ^[1]	Fesoterodine 8 mg vs. Placebo
Method ^[2]	ANCOVA
P Value ^[3]	0.7485
LS Mean Difference ^[4]	-1.6251
Standard Error of the mean	± 5.0346
95% Confidence Interval	( -11.7926 to 8.5425 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

11. Secondary:

Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: Baseline ]

Measure Type	Secondary
Measure Title	Rey Auditory Verbal Learning Test (RAVLT)
Measure Description	RAVLT evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval. Assessment of RAVLT is between 10 to 15 minutes; Performance variable: the sum of the number of words recalled successfully on the delayed recall trial. Higher score meant a better performance.
Time Frame	Baseline
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.

Reporting Groups

	Description
Fesoterodine 4 mg	Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Fesoterodine 8 mg	Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Aplrazolam 1 mg	Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Placebo	Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.

Measured Values

	Fesoterodine 4 mg	Fesoterodine 8 mg	Aplrazolam 1 mg	Placebo
Number of Participants Analyzed [units: participants]	18	18	18	18
Rey Auditory Verbal Learning Test (RAVLT) [units: Words Recalled] Mean ± Standard Deviation	6.50 ± 3.884	6.67 ± 3.630	7.22 ± 3.687	6.33 ± 3.378

No statistical analysis provided for Rey Auditory Verbal Learning Test (RAVLT)

12. Secondary:

Rey Auditory Verbal Learning Test (RAVLT) on Day 6 [ Time Frame: Baseline and Day 6 ]

Measure Type	Secondary
Measure Title	Rey Auditory Verbal Learning Test (RAVLT) on Day 6
Measure Description	RAVLT evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval. Assessment of RAVLT is between 10 to 15 minutes; Performance variable: the sum of the number of words recalled successfully on the delayed recall trial. Higher score meant a better performance.
Time Frame	Baseline and Day 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.

Reporting Groups

	Description
Fesoterodine 4 mg	Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Fesoterodine 8 mg	Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Aplrazolam 1 mg	Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
Placebo	Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.

Measured Values

	Fesoterodine 4 mg	Fesoterodine 8 mg	Aplrazolam 1 mg	Placebo
Number of Participants Analyzed [units: participants]	18	18	18	18
Rey Auditory Verbal Learning Test (RAVLT) on Day 6 [units: Words Recalled] Least Squares Mean ± Standard Error	0.1565 ± 0.5825	-0.1780 ± 0.5820	-3.9222 ± 0.5890	-0.1119 ± 0.5862

Statistical Analysis 1 for Rey Auditory Verbal Learning Test (RAVLT) on Day 6

Groups ^[1]	Fesoterodine 4 mg vs. Placebo
Method ^[2]	ANCOVA
P Value ^[3]	0.7458
LS Mean Difference ^[4]	0.2684
Standard Error of the mean	± 0.8243
95% Confidence Interval	( -1.3788 to 1.9157 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Rey Auditory Verbal Learning Test (RAVLT) on Day 6

Groups ^[1]	Fesoterodine 8 mg vs. Placebo
Method ^[2]	ANCOVA
P Value ^[3]	0.9366
LS Mean Difference ^[4]	-0.0661
Standard Error of the mean	± 0.8277
95% Confidence Interval	( -1.7202 to 1.5880 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

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Certain Agreements:

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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01161472 History of Changes
Other Study ID Numbers:	A0221086
Study First Received:	July 12, 2010
Results First Received:	May 25, 2012
Last Updated:	May 25, 2012
Health Authority:	United States: Food and Drug Administration

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