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A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy

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ClinicalTrials.gov Identifier: NCT01006122
Recruitment Status : Completed
First Posted : November 2, 2009
Results First Posted : May 9, 2014
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Excessive Daytime Sleepiness
Narcolepsy
Interventions Drug: Placebo
Drug: PF-03654746
Enrollment 95
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PF-03654746 First, Then Placebo Placebo First Then, PF-03654746
Hide Arm/Group Description PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in the first double-blind (DB) intervention period then placebo matched to PF-03654746 orally once daily as PIC in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period. Placebo matched to PF-03654746 orally once daily as PIC in the first DB intervention period then PF-03654746 at a starting dose of 0.25 mg to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as PIC in the TP at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week SP at fixed dose stabilized in the TP in the second DB intervention. A washout period of at least 7 days was maintained between each treatment period.
Period Title: First Double-blind Intervention Period
Started 47 48
Completed 31 31
Not Completed 16 17
Reason Not Completed
Lost to Follow-up             0             2
Protocol Violation             1             1
Pregnancy             0             1
Withdrawal by Subject             9             8
Does not meet entrance criteria             1             0
Lack of Efficacy             2             1
Other             3             0
Adverse Event             0             4
Period Title: Wash-out Period (at Least 7 Days)
Started 31 31
Completed 31 31
Not Completed 0 0
Period Title: Second Double-blind Intervention Period
Started 31 31
Completed 29 24
Not Completed 2 7
Reason Not Completed
Adverse Event             1             1
Protocol Violation             1             0
Lost to Follow-up             0             3
Withdrawal by Subject             0             2
Death             0             1
Arm/Group Title Entire Study
Hide Arm/Group Description Included all participants randomized to receive PF-03654746 first and placebo first.
Overall Number of Baseline Participants 95
Hide Baseline Analysis Population Description
Full analysis set (FAS) consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 95 participants
32.1  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants
Female
58
  61.1%
Male
37
  38.9%
1.Primary Outcome
Title Change From Baseline in Maintenance of Wakefulness Test (MWT) Score at Day 21 of Stable Dosing Phase
Hide Description MWT measured ability of participant to remain awake. Participants were instructed to try and remain awake during series of six 20-minute periods in a semi-recumbent position in dark room. Each period was terminated immediately after sleep onset or at end of 20 minutes if no sleep occurred. Poorest outcome was 0 minute the best was 20 minutes.
Time Frame Baseline, Day 21 of stable dosing phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here "N"(number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" signifies participants who were evaluable at specified time points for each arm.
Arm/Group Title PF-03654746 Placebo
Hide Arm/Group Description:
PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Overall Number of Participants Analyzed 77 79
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline: n=77, 79 6.30  (4.155) 5.81  (4.126)
Change at Day 21 (SP): n=54, 60 1.29  (4.518) 1.10  (3.878)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments One sided p-value was based on linear mixed effects model with treatment and period as fixed effects, baseline MWT as a covariate and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.418
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value 0.16
Confidence Interval (2-Sided) 80%
-0.81 to 1.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.747
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase
Hide Description ESS is a simple, self-administered questionnaire which provides a measurement of the participant's general level of daytime sleepiness. The participant rates the chance that he/she would fall asleep when in 8 different situations (e.g. sitting and reading, talking to someone, etc.) commonly encountered in daily life on a scale of 0 (no daytime sleep) to 3 (maximum daytime sleep). Total score was the sum of 8 situations ranges from 0 to 24 with a higher score indicating greater daytime sleepiness.
Time Frame Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title PF-03654746 Placebo
Hide Arm/Group Description:
PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Overall Number of Participants Analyzed 78 79
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: n=78, 79 16.54  (4.196) 16.32  (4.407)
Change at Day 5 (TP): n=67, 78 -2.06  (2.928) -0.74  (2.770)
Change at Day 10 (TP): n=69, 76 -2.00  (3.325) -1.16  (3.402)
Change at Day 15 (TP): n=67, 74 -2.67  (3.933) -1.35  (4.053)
Change at Day 20 (TP): n=59, 65 -2.42  (3.944) -1.74  (4.542)
Change at Day 7 (SP): n=63, 67 -2.92  (4.386) -1.81  (4.743)
Change at Day 14 (SP): n=63, 67 -2.89  (4.618) -1.57  (4.762)
Change at Day 21 (SP): n=56, 61 -2.45  (3.765) -1.80  (5.231)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 5 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.73
Confidence Interval (2-Sided) 80%
-1.32 to -0.15
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.457
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 10 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.247
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.31
Confidence Interval (2-Sided) 80%
-0.89 to 0.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.453
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 15 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.095
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.60
Confidence Interval (2-Sided) 80%
-1.19 to -0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.457
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 20 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.604
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value 0.13
Confidence Interval (2-Sided) 80%
-0.50 to 0.75
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.487
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 7 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.232
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.35
Confidence Interval (2-Sided) 80%
-0.95 to 0.26
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.473
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 14 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.093
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.63
Confidence Interval (2-Sided) 80%
-1.23 to -0.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.473
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 21 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.274
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.30
Confidence Interval (2-Sided) 80%
-0.94 to 0.34
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.498
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Brief Fatigue Inventory (BFI) Global Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase
Hide Description BFI is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. There are 3 questions that pertain specifically to level of fatigue and 6 questions regarding general activity level, mood and quality of life, all are answered on an 11-point scale, with “0” being “No fatigue at all” to “10” being “As bad as you can imagine”. The global score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. Higher global scores are associated with more severe fatigue.
Time Frame Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title PF-03654746 Placebo
Hide Arm/Group Description:
PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Overall Number of Participants Analyzed 78 79
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: n=78, 79 5.01  (2.564) 5.02  (2.436)
Change at Day 5 (TP): n=67, 78 -1.02  (2.116) -0.77  (1.900)
Change at Day 10 (TP): n=68, 76 -0.85  (1.928) -0.88  (1.668)
Change at Day 15 (TP): n=67, 74 -1.18  (2.177) -0.78  (2.193)
Change at Day 20 (TP): n=59, 65 -0.86  (2.104) -0.89  (1.816)
Change at Day 7 (SP): n=63, 67 -0.96  (2.218) -1.07  (2.214)
Change at Day 14 (SP): n=63, 67 -0.98  (2.195) -1.11  (2.146)
Change at Day 21 (SP): n=56, 61 -0.74  (2.265) -1.09  (2.248)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 5 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.121
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.29
Confidence Interval (2-Sided) 80%
-0.60 to 0.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.244
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 10 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.394
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.07
Confidence Interval (2-Sided) 80%
-0.38 to 0.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.243
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 15 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.073
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.36
Confidence Interval (2-Sided) 80%
-0.67 to -0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.244
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 20 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.495
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.00
Confidence Interval (2-Sided) 80%
-0.34 to 0.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.260
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 7 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.711
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value 0.14
Confidence Interval (2-Sided) 80%
-0.18 to 0.46
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.253
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 14 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.767
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value 0.18
Confidence Interval (2-Sided) 80%
-0.14 to 0.51
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.253
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 21 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.698
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value 0.14
Confidence Interval (2-Sided) 80%
-0.20 to 0.48
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.266
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Cataplexy Episodes at Day 7, 14, 21 of Stable Dosing Phase
Hide Description Cataplexy is a medical condition in which a person suffers sudden physical collapse though remaining conscious. Cataplexy episodes is number of counts the participant had cataplexy.
Time Frame Baseline, Day 7, 14, 21 of stable dosing phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title PF-03654746 Placebo
Hide Arm/Group Description:
PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Overall Number of Participants Analyzed 63 72
Mean (Standard Deviation)
Unit of Measure: cataplexy episodes
Baseline: n=63, 72 5.71  (9.683) 5.92  (12.658)
Change at Day 7 (SP): n=53, 58 -1.91  (6.473) -2.67  (8.717)
Change at Day 14 (SP): n=51, 60 -1.71  (7.103) -2.63  (8.471)
Change at Day 21 (SP): n=44, 57 -2.09  (7.882) -2.95  (9.720)
5.Secondary Outcome
Title Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase
Hide Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality, social functioning (SF), role emotional (RE) and mental health (MH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Time Frame Baseline, Day 21 of stable dosing phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title PF-03654746 Placebo
Hide Arm/Group Description:
PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Overall Number of Participants Analyzed 78 79
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: PF (n=78, 79) 79.68  (22.554) 80.38  (22.882)
Baseline: RP (n=77, 79) 61.20  (31.305) 65.19  (30.482)
Baseline: BP (n=78, 79) 68.97  (24.685) 73.89  (26.619)
Baseline: GH (n=78, 79) 71.15  (16.701) 73.03  (18.660)
Baseline: Vitality (n=78, 79) 38.46  (23.560) 38.69  (21.443)
Baseline: SF (n=78, 79) 68.11  (28.536) 69.30  (26.690)
Baseline: RE (n=77, 79) 79.65  (26.782) 79.01  (26.550)
Baseline: MH (n=78, 79) 74.62  (15.411) 77.34  (15.209)
Change at Day 21 (SP): PF (n=55, 61) 0.55  (15.174) 4.75  (15.450)
Change at Day 21 (SP): RP (n=54, 61) 1.16  (22.191) -1.54  (27.235)
Change at Day 21 (SP): BP (n=55, 61) 1.02  (16.455) 2.23  (20.078)
Change at Day 21 (SP): GH (n=55, 61) -0.95  (11.762) 0.52  (10.062)
Change at Day 21 (SP): Vitality (n=55, 61) 1.93  (19.833) 1.64  (22.329)
Change at Day 21 (SP): SF (n=55, 61) -2.05  (18.283) 3.48  (23.288)
Change at Day 21 (SP): RE (n=54, 61) -0.93  (21.577) 6.56  (23.477)
Change at Day 21 (SP): MH (n=55, 61) -2.45  (11.258) -0.25  (17.307)
6.Secondary Outcome
Title Clinical Global Impression of Improvement (CGI-I) Scale Score
Hide Description CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: “Compared to your subject’s condition at the beginning of treatment, how much has your subject changed?”. Improvement was compared to baseline and was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Time Frame Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title PF-03654746 Placebo
Hide Arm/Group Description:
PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Overall Number of Participants Analyzed 69 77
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 5 (TP): n=67, 77 3.51  (0.859) 3.75  (0.905)
Day 10 (TP): n=69, 76 3.48  (0.994) 3.61  (0.850)
Day 15 (TP): n=67, 74 3.36  (0.980) 3.35  (1.052)
Day 20 (TP): n=59, 65 3.34  (1.124) 3.29  (1.071)
Day 7 (SP): n=63, 67 3.16  (1.139) 3.19  (1.076)
Day 14 (SP): n=64, 67 3.11  (1.210) 3.33  (1.021)
Day 21 (TP): n=56, 60 3.25  (1.210) 3.27  (1.177)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 5 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.127
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.16
Confidence Interval (2-Sided) 80%
-0.34 to 0.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.142
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 10 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.303
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.07
Confidence Interval (2-Sided) 80%
-0.25 to 0.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.141
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 15 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.738
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value 0.09
Confidence Interval (2-Sided) 80%
-0.09 to 0.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.143
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 20 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.850
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value 0.16
Confidence Interval (2-Sided) 80%
-0.04 to 0.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.152
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 7 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.631
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value 0.05
Confidence Interval (2-Sided) 80%
-0.14 to 0.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.148
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 14 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.160
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -0.15
Confidence Interval (2-Sided) 80%
-0.34 to 0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.147
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-03654746, Placebo
Comments Day 21 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.541
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value 0.02
Confidence Interval (2-Sided) 80%
-0.18 to 0.22
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.156
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Computer Based Objective Cognition Testing (CogState) Groton Maze Learning Task (GMLT)
Hide Description GMLT: a cognitive test which assessed executive function. Participant was shown a 10 multiplied by 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. Score ranges from 0 to infinity. Lower scores meant a better performance.
Time Frame Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title PF-03654746 Placebo
Hide Arm/Group Description:
PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Overall Number of Participants Analyzed 78 79
Mean (Standard Deviation)
Unit of Measure: errors
Baseline: n=78, 79 48.71  (19.91) 53.19  (27.33)
Day 5 (TP): n=72, 79 48.49  (21.24) 48.32  (23.68)
Day 10 (TP): n=72, 78 44.88  (15.41) 43.59  (17.24)
Day 15 (TP): n=67, 75 44.54  (16.73) 44.36  (18.11)
Day 20 (TP): n=60, 66 43.17  (17.09) 45.47  (19.82)
Day 21 (SP): n=61, 65 44.48  (17.45) 47.02  (25.52)
8.Secondary Outcome
Title Computer Based Objective Cognition Testing (CogState) Detection Speed
Hide 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 (msec)]. Scores ranges from 2 (best) to 3.3 (worst). Lower scores meant a better performance.
Time Frame Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title PF-03654746 Placebo
Hide Arm/Group Description:
PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Overall Number of Participants Analyzed 78 79
Mean (Standard Deviation)
Unit of Measure: log10 msec
Baseline: n=78, 79 2.55  (0.13) 2.55  (0.12)
Day 5 (TP): n=73, 79 2.51  (0.1) 2.52  (0.11)
Day 10 (TP): n=72, 78 2.52  (0.1) 2.52  (0.1)
Day 15 (TP): n=67, 75 2.53  (0.12) 2.53  (0.1)
Day 20 (TP): n=60, 66 2.52  (0.11) 2.52  (0.11)
Day 21 (SP): n=61, 64 2.54  (0.12) 2.54  (0.1)
9.Secondary Outcome
Title Computer Based Objective Cognition Testing (CogState) Identification Speed
Hide 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 msec). Score ranges from 2 (best) to 3.3 (worst). Lower scores meant a better performance.
Time Frame Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title PF-03654746 Placebo
Hide Arm/Group Description:
PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Overall Number of Participants Analyzed 78 79
Mean (Standard Deviation)
Unit of Measure: log10 msec
Baseline: n=78, 79 2.74  (0.11) 2.72  (0.10)
Day 5 (TP): n=72, 79 2.72  (0.09) 2.72  (0.09)
Day 10 (TP): n=72, 78 2.72  (0.10) 2.73  (0.10)
Day 15 (TP): n=67, 75 2.73  (0.09) 2.73  (0.09)
Day 20 (TP): n=60, 66 2.72  (0.08) 2.73  (0.11)
Day 21 (SP): n=61, 65 2.73  (0.10) 2.73  (0.10)
10.Secondary Outcome
Title Computer Based Objective Cognition Testing (CogState) One Card Learning
Hide 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 of the proportion of correct responses. Score ranges from 0 (worse) to 1.57 (best). Higher scores meant a better performance.
Time Frame Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title PF-03654746 Placebo
Hide Arm/Group Description:
PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Overall Number of Participants Analyzed 77 79
Mean (Standard Deviation)
Unit of Measure: arcsine (square root proportion correct)
Baseline: n=77, 79 1.01  (0.15) 1.02  (0.13)
Day 5 (TP): n=72, 79 1.01  (0.14) 1.02  (0.13)
Day 10 (TP): n=72,78 1.01  (0.13) 1.02  (0.12)
Day 15 (TP): n=67, 75 1.00  (0.14) 1.01  (0.14)
Day 20 (TP): n=59, 66 1.02  (0.17) 1.02  (0.17)
Day 21 (SP): n=61, 65 1.01  (0.16) 1.02  (0.16)
11.Secondary Outcome
Title Computer Based Objective Cognition Testing (CogState) Continuous Paired Associate Learning (CPAL)
Hide 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. Score ranges from 0 to infinity. Lower scores meant a better performance.
Time Frame Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title PF-03654746 Placebo
Hide Arm/Group Description:
PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Overall Number of Participants Analyzed 74 78
Mean (Standard Deviation)
Unit of Measure: errors
Baseline: n=74, 75 48.42  (57.11) 46.4  (52.59)
Day 5 (TP): n=71, 77 37.18  (48.03) 37.01  (48.86)
Day 10 (TP): n=70, 78 36.64  (54.25) 30.54  (42.4)
Day 15 (TP): n=66, 75 27.59  (36.84) 25.52  (37.39)
Day 20 (TP): n=59, 65 29.9  (40.17) 19.49  (27.69)
Day 21 (SP): n=61, 64 31.75  (42.8) 24.98  (32.13)
12.Secondary Outcome
Title Computer Based Objective Cognition Testing (CogState ) Composite Score
Hide Description CogState had 5 outcome measures that measured the cognitive constructs. GMLT, detection, identification, one card learning and CPAL. GMLT score range: 0 (best) to infinity (worst), detection and identification score range: 2 (best) to 3.3 (worst); One card learning score range: 0 (worse) to 1.57 (best) and CPAL score range: 0 (best) to infinity (worst). The individual score was standardized at each assessment and was then averaged to yield a composite score; total possible score: minus infinity to plus infinity. Positive composite score=improved performance.
Time Frame Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title PF-03654746 Placebo
Hide Arm/Group Description:
PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Overall Number of Participants Analyzed 74 79
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline: n=74, 79 0.02  (0.72) 0.06  (0.6)
Day 5 (TP): n=73, 79 0.19  (0.62) 0.19  (0.58)
Day 10 (TP): n=72, 78 0.21  (0.58) 0.23  (0.55)
Day 15 (TP): n=67, 75 0.19  (0.54) 0.21  (0.53)
Day 20 (TP): n=60, 66 0.24  (0.56) 0.25  (0.59)
Day 21 (SP): n=61, 65 0.16  (0.67) 0.17  (0.66)
13.Other Pre-specified Outcome
Title Number of Participants With Vital Signs Data
Hide Description Criteria for potential clinical concern in vital signs: supine and standing systolic blood pressure (BP) less than (<) 90 millimeter of mercury (mmHg), supine and standing diastolic BP <50 mmHg, supine and standing heart rate <40 beats per minute (bpm) or >140 bpm. Number of participants who met the criteria for potential clinical concern was reported.
Time Frame Baseline up to 7-10 days after Day 21 (stable dosing phase)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set consisted of all participants who received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title PF-03654746 Placebo
Hide Arm/Group Description:
PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Overall Number of Participants Analyzed 74 79
Measure Type: Number
Unit of Measure: participants
Supine systolic BP: < 90 mmHg 2 3
Standing systolic BP: < 90 mmHg 3 5
Supine diastolic BP: <50 mmHg 0 1
14.Other Pre-specified Outcome
Title Number of Participants With Laboratory Abnormalities
Hide Description Laboratory parameters included hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (protein, blood), and clinical chemistry (glucose). Total number of participants with laboratory abnormalities was reported.
Time Frame Baseline up to Day 21 of stable dosing phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set consisted of all participants who received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title PF-03654746 Placebo
Hide Arm/Group Description:
PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Overall Number of Participants Analyzed 74 79
Measure Type: Number
Unit of Measure: participants
57 61
15.Other Pre-specified Outcome
Title Number of Participants With Electrocardiogram (ECG) Findings
Hide Description Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=200 msec, maximum Fridericia’s correction of QT (QTcF) interval of 450 to <480 msec, 480 to <500 msec and >=500 msec. Number of participants who met the criteria for potential clinical concern in ECG findings were reported.
Time Frame Baseline up to Day 21 of stable dosing phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set consisted of all participants who received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title PF-03654746 Placebo
Hide Arm/Group Description:
PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Overall Number of Participants Analyzed 74 79
Measure Type: Number
Unit of Measure: participants
4 4
16.Other Pre-specified Outcome
Title Medical Outcomes Study (MOS) Sleep Scale Score
Hide Description Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1(some questions are reversed so that high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range:0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create 7 scale scores and 2 sleep scale index. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), sleep quantity, snoring, awaken short of breath (ASoB), somnolence, sleep adequacy and optimal sleep; and a 9-item overall sleep problems index(SPI) I and II Subscales range from 0-100 except for sleep quantity (SQ) ranging from0 to 24. Except for sleep quantity, higher scores=greater impairment.
Time Frame Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title PF-03654746 Placebo
Hide Arm/Group Description:
PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Overall Number of Participants Analyzed 78 79
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: SD (n=78,79) 20.48  (18.869) 22.26  (20.420)
Baseline: Somnolence (n=78,79) 64.70  (24.409) 66.50  (24.529)
Baseline: Adequacy (n=78,79) 34.62  (27.666) 34.18  (26.967)
Baseline: Snore (n=78,79) 26.67  (31.196) 22.53  (30.444)
Baseline: ASoB (n=78,79) 14.10  (23.043) 13.92  (23.173)
Baseline: SQ (n=78,79) 7.24  (1.505) 7.18  (1.607)
Baseline: Optimal sleep (n=78,79) 0.58  (0.497) 0.51  (0.503)
Baseline: SPI I (n=78,79) 40.85  (17.576) 42.53  (15.314)
Baseline: SPI II (n=78,79) 41.04  (16.508) 42.24  (14.486)
Day 5 (TP): SD (n=67,78) 22.46  (20.818) 19.15  (21.942)
Day 5 (TP): Somnolence (n=67,78) 55.42  (27.834) 58.89  (26.240)
Day 5 (TP): Adequacy (n=67,78) 35.82  (28.292) 36.92  (27.648)
Day 5 (TP): Snore (n=67,78) 22.99  (29.182) 18.46  (28.425)
Day 5 (TP): ASoB (n=67,78) 8.66  (15.657) 11.54  (20.263)
Day 5 (TP): SQ (n=67,78) 7.04  (1.408) 6.88  (1.494)
Day 5 (TP): Optimal sleep (n=67,78) 0.48  (0.503) 0.55  (0.501)
Day 5 (TP): SPI I (n=67,78) 38.91  (17.315) 38.46  (16.158)
Day 5 (TP): SPI II (n=67,78) 38.38  (17.252) 38.14  (15.509)
Day 10 (TP): SD (n=69,76) 21.43  (20.637) 16.94  (18.685)
Day 10 (TP): Somnolence (69,76) 58.55  (26.516) 59.74  (25.979)
Day 10 (TP): Adequacy (n=69,76) 33.33  (27.422) 35.66  (28.064)
Day 10 (TP): Snore (n=69,76) 19.71  (26.007) 20.26  (27.999)
Day 10 (TP): ASoB (n=69,76) 12.17  (21.204) 7.89  (15.690)
Day 10 (TP): SQ (n=69,76) 7.12  (1.255) 6.99  (1.322)
Day 10 (TP): Optimal sleep (n=69,76) 0.58  (0.497) 0.58  (0.497)
Day 10 (TP): SPI I (n=69,76) 40.10  (16.626) 37.76  (15.929)
Day 10 (TP): SPI II (n=69,76) 39.70  (16.628) 37.03  (14.711)
Day 15 (TP): SD (n=67,74) 22.03  (21.177) 17.11  (20.585)
Day 15 (TP): Somnolence (67,74) 53.93  (26.072) 58.11  (28.467)
Day 15 (TP): Adequacy (n=67,74) 36.27  (29.379) 38.78  (29.188)
Day 15 (TP): Snore (n=67,74) 19.70  (26.627) 16.49  (26.350)
Day 15 (TP): ASoB (n=67,74) 12.24  (22.551) 11.35  (22.715)
Day 15 (TP): SQ (n=67,74) 6.90  (1.293) 7.15  (1.279)
Day 15 (TP): Optimal sleep (n=67,74) 0.60  (0.494) 0.64  (0.485)
Day 15 (TP): SPI I (n=67,74) 38.71  (18.294) 36.67  (16.889)
Day 15 (TP): SPI II (n=67,74) 38.05  (17.748) 36.28  (16.884)
Day 20 (TP): SD (n=59,65) 22.99  (21.611) 16.46  (17.522)
Day 20 (TP): Somnolence (59,65) 56.05  (28.070) 57.23  (28.720)
Day 20 (TP): Adequacy (n=59,65) 36.95  (28.723) 43.85  (30.088)
Day 20 (TP): Snore (n=59,65) 22.37  (30.869) 15.69  (23.316)
Day 20 (TP): ASoB (n=59,65) 10.85  (17.936) 8.92  (20.625)
Day 20 (TP): SQ (n=59,65) 7.27  (1.257) 7.40  (1.285)
Day 20 (TP): Optimal sleep (n=59,65) 0.69  (0.464) 0.68  (0.471)
Day 20 (TP): SPI I (n=59,65) 39.32  (19.206) 34.05  (16.240)
Day 20 (TP): SPI II (n=59,65) 38.65  (18.858) 34.02  (16.200)
Day 7 (SP): SD (n=63,67) 20.73  (20.529) 14.70  (18.250)
Day 7 (SP): Somnolence (63,67) 49.84  (29.883) 57.81  (30.003)
Day 7 (SP): Adequacy (n=63,67) 40.63  (30.894) 41.04  (29.032)
Day 7 (SP): Snore (n=63,67) 19.37  (29.614) 20.90  (28.801)
Day 7 (SP): ASoB (n=63,67) 13.65  (23.231) 8.96  (18.516)
Day 7 (SP): SQ (n=63,67) 7.05  (1.184) 7.21  (1.297)
Day 7 (SP): Optimal sleep (n=63,67) 0.65  (0.481) 0.66  (0.478)
Day 7 (SP): SPI I (n=63,67) 36.19  (18.597) 34.98  (16.518)
Day 7 (SP): SPI II (n=63,67) 35.74  (18.159) 34.43  (16.710)
Day 14 (SP): SD (n=63,67) 23.37  (22.364) 16.55  (19.925)
Day 14 (SP): Somnolence (63,67) 51.53  (30.578) 56.62  (28.554)
Day 14 (SP): Adequacy (n=63,67) 41.27  (32.353) 42.09  (33.099)
Day 14 (SP): Snore (n=63,67) 19.37  (28.953) 19.10  (27.509)
Day 14 (SP): ASoB (n=63,67) 12.38  (20.138) 10.45  (19.183)
Day 14 (SP): SQ (n=63,67) 6.97  (1.282) 7.19  (1.395)
Day 14 (SP): Optimal sleep (n=63,67) 0.63  (0.485) 0.67  (0.473)
Day 14 (SP): SPI I (n=63,67) 37.99  (20.130) 34.92  (19.283)
Day 14 (SP): SPI II (n=63,67) 37.27  (20.493) 34.92  (18.611)
Day 21 (SP): SD (n=56,61) 21.27  (21.830) 16.45  (17.791)
Day 21 (SP): Somnolence (n=56,61) 53.93  (30.252) 55.08  (30.133)
Day 21 (SP): Adequacy (n=56,61) 35.71  (31.729) 39.67  (30.874)
Day 21 (SP): Snore (n=56,61) 20.36  (29.168) 20.98  (29.081)
Day 21 (SP): ASoB (n=56,61) 10.71  (17.874) 6.89  (15.442)
Day 21 (SP): SQ (n=56,61) 6.95  (1.432) 7.38  (1.227)
Day 21 (SP): Optimal sleep (n=56,61) 0.64  (0.483) 0.69  (0.467)
Day 21 (SP): SPI I (n=56,61) 38.93  (19.354) 35.52  (17.919)
Day 21 (SP): SPI II (n=56,61) 37.91  (19.436) 34.78  (17.597)
17.Other Pre-specified Outcome
Title Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS)
Hide Description Sheehan-STS is an 8-item clinician/participant administered prospective rating scale and an indicator of trigger assessment that tracks both treatment-emergent suicidal ideation and behaviors). Items 1a, 2-6, 8 scored on 5-point Likert scale (0=not at all, 1=a little, 2=moderately, 3=very, and 4=extremely). Items 1, 1b, 7, an indicator of trigger assessment (TA) require yes/no response. Items included 1= Ever suffer any accident, 1a= Extent plan/intend to hurt yourself, 1b= Intend to die, 2= Wish dead, 3= Want to harm yourself, 4= Think about suicide, 5= Plan for a suicide, 6= Prepare for suicide (PS) with intent to die (ITD), 7= Injure yourself on purpose, 8= Attempt suicide. Result for item 1 indicates if any of the participant ever suffered any accident, 1b indicates if any of the participant intended to die, 7 indicates if any of the participant injured themselves purposely and trigger assessment indicates if any of the participant evoked trigger assessment.
Time Frame Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively. Results for a parameter are not reported at certain time points since none of the participants were evaluable for the parameter at those time points.
Arm/Group Title PF-03654746 Placebo
Hide Arm/Group Description:
PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
Overall Number of Participants Analyzed 78 79
Measure Type: Number
Unit of Measure: participants
Baseline:Ever suffer any accident (n=78, 79) 0 1
Baseline:Hurt Yourself:Not at all (n=0,1) 0 1
Baseline:Wish dead:Not at all (n=78,79) 77 79
Baseline:Wish dead:A little (n=78,79) 1 0
Baseline:Harm yourself:Not at all (n=78,79) 77 79
Baseline:Harm yourself:A little (n=78,79) 1 0
Baseline:Think about suicide:Not at all (n=78,79) 77 79
Baseline:Think about suicide:A little (n=78, 79) 1 0
Baseline:Plan suicide:Not at all (n=78, 79) 78 79
Baseline:PS with ITD:Not at all (n=78, 79) 78 79
Baseline:Injure yourself on purpose (n=78,79) 0 0
Baseline:Attempt suicide:Not at all (n=78, 79) 78 79
Baseline:Trigger assessment (n=78, 79) 1 0
Day 5(TP):Ever suffer any accident (n=78,79) 0 0
Day 5(TP):Wish dead:Not at all (n=68,78) 68 77
Day 5(TP):Wish dead:A little (n=68, 78) 0 1
Day 5(TP):Harm yourself:Not at all (n=68,78) 68 78
Day 5(TP):Think about suicide:Not at all (n=68,78) 68 78
Day 5(TP):Plan suicide:Not at all (n=68,78) 68 78
Day 5(TP):PS with ITD:Not at all (n=68, 78) 68 78
Day 5(TP):Injure yourself on purpose (n=68,78) 0 0
Day 5(TP):Attempt suicide:Not at all (n=68,78) 68 78
Day 5(TP):Trigger assessment (n=68, 78) 0 0
Day 10(TP):Ever suffer any accident (n=69,76) 0 0
Day 10(TP):Intend to die (n=1,0) 0 0
Day 10(TP):Wish dead:Not at all (n=69, 76) 69 76
Day 10(TP):Harm yourself:Not at all (n=69,76) 69 76
Day 10(TP):Think About Suicide:Not at all(n=69,76) 69 76
Day 10(TP):Plan suicide:Not at all (n=69, 76) 69 76
Day 10(TP):PS with ITD:Not at all (n=69, 76) 69 76
Day 10(TP):Injure yourself on purpose (n=69,76) 0 0
Day 10(TP):Attempt suicide:Not at all (n=69, 76) 69 76
Day 10(TP):Trigger assessment (n=69, 76) 0 0
Day 15(TP):Ever suffer any accident (n=67,74) 0 1
Day 15(TP):Hurt Yourself:Not at all (n=0, 1) 0 1
Day 15(TP):Intend to die (n=2,0) 0 0
Day 15(TP):Wish dead:Not at all (n=67,74) 67 74
Day 15(TP):Harm yourself:Not at all (n=67,74) 67 74
Day 15(TP):Think about suicide:Not at all(n=67,74) 67 73
Day 15(TP):Think about suicide:A little (n=67,74) 0 1
Day 15(TP):Plan suicide:Not at all (n=67,74) 67 74
Day 15(TP):PS with ITD:Not at all (n=67,73) 67 73
Day 15(TP):Injure yourself on purpose (n=67,74) 0 0
Day 15(TP):Attempt suicide:Not at all (n=67, 74) 67 74
Day 15(TP):Trigger assessment (n=67,74) 0 0
Day 20(TP):Ever suffer any accident (n=58,64) 0 0
Day 20(TP):Wish dead:Not at all (n=58,64) 58 63
Day 20(TP):Wish dead:A little (n=58,64) 0 1
Day 20(TP):Harm yourself:Not at all (n=58,64) 58 64
Day 20(TP):Think about suicide:Not at all(n=58,64) 58 64
Day 20(TP):Plan suicide:Not at all (n=58,64) 58 64
Day 20(TP):PS with ITD:Not at all (n=58,64) 58 64
Day 20(TP):Injure yourself on purpose (n=58,64) 0 0
Day 20(TP):Attempt suicide:Not at all (n=58, 64) 58 64
Day 20(TP):Trigger assessment (n=58, 64) 0 0
Day 7(SP):Ever suffer any accident (n=63,67) 0 0
Day 7(SP):Intend to die (n=0,1) 0 0
Day 7(SP):Wish dead:Not at all (n=63,67) 63 67
Day 7(SP):Harm yourself:Not at all (n=63,67) 63 67
Day 7(SP):Think about suicide:Not at all(n=63,67) 63 67
Day 7(SP):Plan suicide:Not at all (n=63,67) 63 67
Day 7(SP):PS with ITD:Not at all (n=63,67) 63 67
Day 7(SP):Injure yourself on purpose (n=63,67) 0 0
Day 7(SP):Attempt suicide:Not at all (n=63,67) 63 67
Day 7(SP):Trigger assessment (n=63, 67) 0 0
Day 14(SP):Ever suffer any accident (n=63,67) 0 0
Day 14(SP):Intend to die (n=1,0) 0 0
Day 14(SP):Wish dead:Not at all (n=63,67) 62 67
Day 14(SP):Wish dead:A little (n=63,67) 1 0
Day 14(SP):Harm yourself:Not at all (n=63,67) 63 67
Day 14(SP):Think about suicide:Not at all(n=63,67) 63 67
Day 14(SP):Plan suicide:Not at all (n=63,67) 63 67
Day 14(SP):PS with ITD:Not at all (n=63, 67) 63 67
Day 14(SP):Injure yourself on purpose (n=63,67) 0 0
Day 14(SP):Attempt suicide:Not at all (n=63, 67) 63 67
Day 14(SP):Trigger assessment (n=64,67) 0 0
Day 21(SP):Ever suffer any accident (n=56, 61) 0 0
Day 21(SP):Wish dead:Not at all (n=56,61) 56 61
Day 21(SP):Harm yourself:Not at all (n=56,61) 56 61
Day 21(SP):Think about suicide:Not at all(n=56,61) 56 61
Day 21(SP):Plan suicide:Not at all (n=56,61) 56 61
Day 21(SP):PS with ITD:Not at all (n=56,61) 56 61
Day 21(SP):Injure yourself on purpose (n=56,61) 0 0
Day 21(SP):Attempt suicide:Not at all (n=56,61) 56 61
Day 21(SP):Trigger assessment (n=56,61) 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title PF-03654746 Placebo
Hide Arm/Group Description PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods. Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
All-Cause Mortality
PF-03654746 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PF-03654746 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/78 (1.28%)   1/79 (1.27%) 
Injury, poisoning and procedural complications     
Injury * 1  1/78 (1.28%)  0/79 (0.00%) 
Drug exposure during pregnancy * 1  0/78 (0.00%)  1/79 (1.27%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PF-03654746 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   48/78 (61.54%)   43/79 (54.43%) 
Cardiac disorders     
Palpitations * 1  0/78 (0.00%)  1/79 (1.27%) 
Ear and labyrinth disorders     
Ear discomfort * 1  1/78 (1.28%)  1/79 (1.27%) 
Vertigo * 1  0/78 (0.00%)  2/79 (2.53%) 
Eye disorders     
Eye irritation * 1  1/78 (1.28%)  1/79 (1.27%) 
Eye swelling * 1  1/78 (1.28%)  0/79 (0.00%) 
Lacrimation increased * 1  1/78 (1.28%)  0/79 (0.00%) 
Gastrointestinal disorders     
Abdominal distension * 1  1/78 (1.28%)  1/79 (1.27%) 
Abdominal pain * 1  1/78 (1.28%)  1/79 (1.27%) 
Abdominal pain upper * 1  1/78 (1.28%)  0/79 (0.00%) 
Chapped lips * 1  1/78 (1.28%)  0/79 (0.00%) 
Colitis * 1  0/78 (0.00%)  1/79 (1.27%) 
Constipation * 1  1/78 (1.28%)  1/79 (1.27%) 
Diarrhoea * 1  3/78 (3.85%)  3/79 (3.80%) 
Dry mouth * 1  4/78 (5.13%)  0/79 (0.00%) 
Flatulence * 1  1/78 (1.28%)  1/79 (1.27%) 
Gastritis * 1  0/78 (0.00%)  1/79 (1.27%) 
Gastrooesophageal reflux disease * 1  3/78 (3.85%)  0/79 (0.00%) 
Nausea * 1  4/78 (5.13%)  6/79 (7.59%) 
Tooth impacted * 1  1/78 (1.28%)  0/79 (0.00%) 
Toothache * 1  1/78 (1.28%)  2/79 (2.53%) 
Vomiting * 1  3/78 (3.85%)  3/79 (3.80%) 
General disorders     
Chest pain * 1  2/78 (2.56%)  1/79 (1.27%) 
Fatigue * 1  0/78 (0.00%)  1/79 (1.27%) 
Feeling cold * 1  1/78 (1.28%)  0/79 (0.00%) 
Feeling hot * 1  1/78 (1.28%)  0/79 (0.00%) 
Feeling jittery * 1  0/78 (0.00%)  1/79 (1.27%) 
Irritability * 1  3/78 (3.85%)  1/79 (1.27%) 
Malaise * 1  0/78 (0.00%)  1/79 (1.27%) 
Pyrexia * 1  2/78 (2.56%)  1/79 (1.27%) 
Swelling * 1  0/78 (0.00%)  1/79 (1.27%) 
Immune system disorders     
Seasonal allergy * 1  1/78 (1.28%)  0/79 (0.00%) 
Infections and infestations     
Gastroenteritis * 1  1/78 (1.28%)  0/79 (0.00%) 
Gastroenteritis viral * 1  1/78 (1.28%)  2/79 (2.53%) 
Influenza * 1  2/78 (2.56%)  0/79 (0.00%) 
Nasopharyngitis * 1  3/78 (3.85%)  5/79 (6.33%) 
Otitis externa * 1  1/78 (1.28%)  1/79 (1.27%) 
Pneumonia * 1  1/78 (1.28%)  0/79 (0.00%) 
Sinusitis * 1  1/78 (1.28%)  1/79 (1.27%) 
Upper respiratory tract infection * 1  2/78 (2.56%)  0/79 (0.00%) 
Urinary tract infection * 1  1/78 (1.28%)  1/79 (1.27%) 
Injury, poisoning and procedural complications     
Concussion * 1  0/78 (0.00%)  1/79 (1.27%) 
Contusion * 1  4/78 (5.13%)  0/79 (0.00%) 
Excoriation * 1  0/78 (0.00%)  1/79 (1.27%) 
Foot fracture * 1  0/78 (0.00%)  1/79 (1.27%) 
Joint sprain * 1  1/78 (1.28%)  1/79 (1.27%) 
Muscle strain * 1  1/78 (1.28%)  0/79 (0.00%) 
Post concussion syndrome * 1  0/78 (0.00%)  1/79 (1.27%) 
Investigations     
Blood pressure increased * 1  1/78 (1.28%)  0/79 (0.00%) 
Hepatic enzyme increased * 1  1/78 (1.28%)  0/79 (0.00%) 
Semen volume decreased * 1  0/78 (0.00%)  1/79 (1.27%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  1/78 (1.28%)  0/79 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  2/78 (2.56%)  3/79 (3.80%) 
Groin pain * 1  1/78 (1.28%)  0/79 (0.00%) 
Muscle spasms * 1  0/78 (0.00%)  1/79 (1.27%) 
Myalgia * 1  1/78 (1.28%)  0/79 (0.00%) 
Pain in extremity * 1  1/78 (1.28%)  0/79 (0.00%) 
Nervous system disorders     
Burning sensation * 1  1/78 (1.28%)  0/79 (0.00%) 
Dizziness * 1  2/78 (2.56%)  1/79 (1.27%) 
Dizziness postural * 1  1/78 (1.28%)  0/79 (0.00%) 
Dysgeusia * 1  1/78 (1.28%)  0/79 (0.00%) 
Headache * 1  10/78 (12.82%)  6/79 (7.59%) 
Migraine * 1  1/78 (1.28%)  1/79 (1.27%) 
Somnolence * 1  0/78 (0.00%)  1/79 (1.27%) 
Tremor * 1  1/78 (1.28%)  1/79 (1.27%) 
Psychiatric disorders     
Abnormal dreams * 1  2/78 (2.56%)  0/79 (0.00%) 
Aggression * 1  0/78 (0.00%)  1/79 (1.27%) 
Anxiety * 1  1/78 (1.28%)  0/79 (0.00%) 
Depression * 1  0/78 (0.00%)  1/79 (1.27%) 
Initial insomnia * 1  1/78 (1.28%)  1/79 (1.27%) 
Insomnia * 1  8/78 (10.26%)  3/79 (3.80%) 
Middle insomnia * 1  2/78 (2.56%)  2/79 (2.53%) 
Mood altered * 1  0/78 (0.00%)  1/79 (1.27%) 
Nervousness * 1  1/78 (1.28%)  0/79 (0.00%) 
Nicotine dependence * 1  1/78 (1.28%)  0/79 (0.00%) 
Nightmare * 1  2/78 (2.56%)  1/79 (1.27%) 
Sleep disorder * 1  1/78 (1.28%)  0/79 (0.00%) 
Tension * 1  1/78 (1.28%)  0/79 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  1/78 (1.28%)  0/79 (0.00%) 
Epididymitis * 1  1/78 (1.28%)  1/79 (1.27%) 
Erectile dysfunction * 1  0/78 (0.00%)  1/79 (1.27%) 
Galactorrhoea * 1  1/78 (1.28%)  0/79 (0.00%) 
Menorrhagia * 1  1/78 (1.28%)  1/79 (1.27%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  4/78 (5.13%)  2/79 (2.53%) 
Dry throat * 1  1/78 (1.28%)  0/79 (0.00%) 
Dysphonia * 1  1/78 (1.28%)  0/79 (0.00%) 
Dyspnoea * 1  1/78 (1.28%)  0/79 (0.00%) 
Epistaxis * 1  1/78 (1.28%)  0/79 (0.00%) 
Hiccups * 1  0/78 (0.00%)  1/79 (1.27%) 
Nasal congestion * 1  1/78 (1.28%)  1/79 (1.27%) 
Oropharyngeal pain * 1  3/78 (3.85%)  0/79 (0.00%) 
Rhinorrhoea * 1  1/78 (1.28%)  0/79 (0.00%) 
Skin and subcutaneous tissue disorders     
Cold sweat * 1  1/78 (1.28%)  0/79 (0.00%) 
Dermatitis contact * 1  1/78 (1.28%)  1/79 (1.27%) 
Hyperhidrosis * 1  1/78 (1.28%)  0/79 (0.00%) 
Pain of skin * 1  0/78 (0.00%)  1/79 (1.27%) 
Pruritus * 1  1/78 (1.28%)  0/79 (0.00%) 
Rash generalised * 1  0/78 (0.00%)  1/79 (1.27%) 
Vascular disorders     
Flushing * 1  1/78 (1.28%)  0/79 (0.00%) 
Haematoma * 1  0/78 (0.00%)  1/79 (1.27%) 
Hot flush * 1  1/78 (1.28%)  1/79 (1.27%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v13.1
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.
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
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01006122     History of Changes
Other Study ID Numbers: A8801015
First Submitted: October 29, 2009
First Posted: November 2, 2009
Results First Submitted: April 8, 2014
Results First Posted: May 9, 2014
Last Update Posted: May 9, 2014