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Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam

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ClinicalTrials.gov Identifier: NCT00952653
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : August 2, 2011
Last Update Posted : August 15, 2011
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Desvenlafaxine Succinate Sustained Release
Drug: Midazolam
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DVS SR 50 mg, Midazolam 4 mg
Hide Arm/Group Description Midazolam (MDZ) 4 milligram (mg) syrup (2 mg per milliliter [mg/mL]) as a single oral dose Period 1 / Day 1. Desvenlafaxine sustained-release formulation (DVS SR) 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
Period Title: Period 1: MDZ Alone
Started 28
Completed 28
Not Completed 0
Period Title: Period 2: Coadministration DVS SR, MDZ
Started 28
Completed 28
Not Completed 0
Arm/Group Title DVS SR 50 mg, Midazolam 4 mg
Hide Arm/Group Description Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1. DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants
18 to 25 years 2
26 to 35 years 9
36 to 45 years 13
> 45 years 4
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
12
  42.9%
Male
16
  57.1%
1.Primary Outcome
Title Midazolam Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR
Hide Description AUCinf measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).
Time Frame Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population: all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=number of participants contributing to the mean.
Arm/Group Title Midazolam 4 mg (Period 1) DVS SR 50 mg, Midazolam 4 mg (Period 2)
Hide Arm/Group Description:
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
Overall Number of Participants Analyzed 26 25
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
54.69  (26.670) 39.45  (13.301)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Midazolam 4 mg (Period 1), DVS SR 50 mg, Midazolam 4 mg (Period 2)
Comments DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction [that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam], where overall study power is to be based on the product of the individual powers of the parameters of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of adjusted geometric means
Estimated Value 71.40
Confidence Interval (2-Sided) 90%
65.08 to 78.33
Estimation Comments Values have been back-transformed from the log scale.
2.Primary Outcome
Title Midazolam Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR
Hide Description Cmax measured as nanograms per milliliters (ng/mL).
Time Frame Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; N=number of participants contributing to the mean.
Arm/Group Title Midazolam 4 mg (Period 1) DVS SR 50 mg, Midazolam 4 mg (Period 2)
Hide Arm/Group Description:
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
Overall Number of Participants Analyzed 26 26
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
21.20  (7.1216) 18.24  (5.1116)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Midazolam 4 mg (Period 1), DVS SR 50 mg, Midazolam 4 mg (Period 2)
Comments DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction [that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam], where overall study power is to be based on the product of the individual powers of the parameters of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of adjusted geometric means
Estimated Value 86.08
Confidence Interval (2-Sided) 90%
79.04 to 93.74
Estimation Comments Values have been back-transformed from the log scale.
3.Primary Outcome
Title 1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR
Hide Description 1-Hydroxy-Midazolam is an analyte of Midazolam.
Time Frame Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; N=number of participants contributing to the mean.
Arm/Group Title Midazolam 4 mg (Period 1) DVS SR 50 mg, Midazolam 4 mg (Period 2)
Hide Arm/Group Description:
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
Overall Number of Participants Analyzed 26 26
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
36.87  (28.230) 30.74  (14.649)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Midazolam 4 mg (Period 1), DVS SR 50 mg, Midazolam 4 mg (Period 2)
Comments DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction [that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam], where overall study power is to be based on the product of the individual powers of the parameters of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of adjusted geometric means
Estimated Value 92.55
Confidence Interval (2-Sided) 90%
87.43 to 97.97
Estimation Comments Values have been back-transformed from the log scale.
4.Primary Outcome
Title 1-Hydroxy-Midazolam (Analyte) Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR
Hide Description [Not Specified]
Time Frame Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; N=number of participants contributing to the mean.
Arm/Group Title Midazolam 4 mg (Period 1) DVS SR 50 mg, Midazolam 4 mg (Period 2)
Hide Arm/Group Description:
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
Overall Number of Participants Analyzed 26 26
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
14.93  (6.5282) 15.10  (6.2472)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Midazolam 4 mg (Period 1), DVS SR 50 mg, Midazolam 4 mg (Period 2)
Comments DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction [that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam], where overall study power is to be based on the product of the individual powers of the parameters of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of adjusted geometric means
Estimated Value 101.17
Confidence Interval (2-Sided) 90%
92.96 to 110.11
Estimation Comments Values have been back-transformed from the log scale.
5.Secondary Outcome
Title Midazolam Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR
Hide Description [Not Specified]
Time Frame Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; N=number of participants contributing to the mean.
Arm/Group Title Midazolam 4 mg (Period 1) DVS SR 50 mg, Midazolam 4 mg (Period 2)
Hide Arm/Group Description:
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
Overall Number of Participants Analyzed 26 26
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
52.85  (23.980) 38.11  (12.522)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Midazolam 4 mg (Period 1), DVS SR 50 mg, Midazolam 4 mg (Period 2)
Comments DVS SR + Midazolam (test) versus Midazolam (reference)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of adjusted geometric means
Estimated Value 72.10
Confidence Interval (2-Sided) 90%
66.04 to 78.72
Estimation Comments Values have been back-transformed from the log scale.
6.Secondary Outcome
Title Midazolam Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR
Hide Description [Not Specified]
Time Frame Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; N=number of participants contributing to the median.
Arm/Group Title Midazolam 4 mg (Period 1) DVS SR 50 mg, Midazolam 4 mg (Period 2)
Hide Arm/Group Description:
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
Overall Number of Participants Analyzed 26 26
Median (Full Range)
Unit of Measure: hr
0.517
(0.250 to 1.50)
0.500
(0.250 to 1.02)
7.Secondary Outcome
Title Midazolam Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR
Hide Description [Not Specified]
Time Frame Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; N=number of participants contributing to the mean.
Arm/Group Title Midazolam 4 mg (Period 1) DVS SR 50 mg, Midazolam 4 mg (Period 2)
Hide Arm/Group Description:
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
Overall Number of Participants Analyzed 26 25
Mean (Standard Deviation)
Unit of Measure: hr
5.320  (1.5948) 4.648  (1.7436)
8.Secondary Outcome
Title 1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR
Hide Description [Not Specified]
Time Frame Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; N=number of participants contributing to the mean.
Arm/Group Title Midazolam 4 mg (Period 1) DVS SR 50 mg, Midazolam 4 mg (Period 2)
Hide Arm/Group Description:
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
Overall Number of Participants Analyzed 26 26
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
37.09  (25.371) 32.42  (14.881)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Midazolam 4 mg (Period 1), DVS SR 50 mg, Midazolam 4 mg (Period 2)
Comments DVS SR + Midazolam (test) versus Midazolam (reference)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of adjusted geometric means
Estimated Value 87.39
Confidence Interval (2-Sided) 90%
80.42 to 94.96
Estimation Comments Values have been back-transformed from the log scale.
9.Secondary Outcome
Title 1-Hydroxy-Midazolam (Analyte) Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR
Hide Description [Not Specified]
Time Frame Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; N=number of participants contributing to the median.
Arm/Group Title Midazolam 4 mg (Period 1) DVS SR 50 mg, Midazolam 4 mg (Period 2)
Hide Arm/Group Description:
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
Overall Number of Participants Analyzed 26 26
Median (Full Range)
Unit of Measure: hr
1.00
(0.250 to 1.50)
0.500
(0.250 to 1.02)
10.Secondary Outcome
Title 1-Hydroxy-Midazolam (Analyte) Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR
Hide Description [Not Specified]
Time Frame Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population; N=number of participants contributing to the mean.
Arm/Group Title Midazolam 4 mg (Period 1) DVS SR 50 mg, Midazolam 4 mg (Period 2)
Hide Arm/Group Description:
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
Overall Number of Participants Analyzed 21 20
Mean (Standard Deviation)
Unit of Measure: hr
5.396  (2.0638) 4.616  (1.7976)
Time Frame Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
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. Participants are counted for each treatment sequence.
 
Arm/Group Title Midazolam 4 mg (Period 1) DVS SR 50 mg (Period 2 / Day 1 to Day 5) DVS SR 50 mg + Midazolam 4 mg (Period 2 / Day 6)
Hide Arm/Group Description Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1. DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state). DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
All-Cause Mortality
Midazolam 4 mg (Period 1) DVS SR 50 mg (Period 2 / Day 1 to Day 5) DVS SR 50 mg + Midazolam 4 mg (Period 2 / Day 6)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Midazolam 4 mg (Period 1) DVS SR 50 mg (Period 2 / Day 1 to Day 5) DVS SR 50 mg + Midazolam 4 mg (Period 2 / Day 6)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Midazolam 4 mg (Period 1) DVS SR 50 mg (Period 2 / Day 1 to Day 5) DVS SR 50 mg + Midazolam 4 mg (Period 2 / Day 6)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/28 (75.00%)   16/28 (57.14%)   24/28 (85.71%) 
Gastrointestinal disorders       
Abdominal discomfort  1  0/28 (0.00%)  1/28 (3.57%)  0/28 (0.00%) 
Abdominal distension  1  0/28 (0.00%)  1/28 (3.57%)  0/28 (0.00%) 
Abdominal pain  1  1/28 (3.57%)  4/28 (14.29%)  0/28 (0.00%) 
Constipation  1  0/28 (0.00%)  1/28 (3.57%)  0/28 (0.00%) 
Diarrhoea  1  0/28 (0.00%)  2/28 (7.14%)  0/28 (0.00%) 
Frequent bowel movements  1  0/28 (0.00%)  1/28 (3.57%)  0/28 (0.00%) 
Nausea  1  0/28 (0.00%)  3/28 (10.71%)  0/28 (0.00%) 
Vomiting  1  0/28 (0.00%)  0/28 (0.00%)  1/28 (3.57%) 
General disorders       
Fatigue  1  0/28 (0.00%)  3/28 (10.71%)  4/28 (14.29%) 
Feeling abnormal  1  0/28 (0.00%)  2/28 (7.14%)  0/28 (0.00%) 
Feeling of relaxation  1  1/28 (3.57%)  0/28 (0.00%)  0/28 (0.00%) 
Hunger  1  0/28 (0.00%)  1/28 (3.57%)  1/28 (3.57%) 
Thirst  1  0/28 (0.00%)  1/28 (3.57%)  0/28 (0.00%) 
Injury, poisoning and procedural complications       
Contusion  1  0/28 (0.00%)  1/28 (3.57%)  1/28 (3.57%) 
Metabolism and nutrition disorders       
Decreased appetite  1  0/28 (0.00%)  2/28 (7.14%)  0/28 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/28 (0.00%)  1/28 (3.57%)  0/28 (0.00%) 
Pain in extremity  1  0/28 (0.00%)  0/28 (0.00%)  1/28 (3.57%) 
Sensation of heaviness  1  1/28 (3.57%)  0/28 (0.00%)  0/28 (0.00%) 
Nervous system disorders       
Dizziness  1  1/28 (3.57%)  0/28 (0.00%)  1/28 (3.57%) 
Headache  1  0/28 (0.00%)  6/28 (21.43%)  1/28 (3.57%) 
Hypersomnia  1  0/28 (0.00%)  1/28 (3.57%)  0/28 (0.00%) 
Psychomotor hyperactivity  1  0/28 (0.00%)  0/28 (0.00%)  1/28 (3.57%) 
Somnolence  1  20/28 (71.43%)  0/28 (0.00%)  20/28 (71.43%) 
Psychiatric disorders       
Abnormal dreams  1  0/28 (0.00%)  0/28 (0.00%)  1/28 (3.57%) 
Depressed mood  1  0/28 (0.00%)  1/28 (3.57%)  0/28 (0.00%) 
Insomnia  1  0/28 (0.00%)  3/28 (10.71%)  1/28 (3.57%) 
Middle insomnia  1  0/28 (0.00%)  1/28 (3.57%)  0/28 (0.00%) 
Renal and urinary disorders       
Urine flow decreased  1  0/28 (0.00%)  1/28 (3.57%)  1/28 (3.57%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00952653     History of Changes
Other Study ID Numbers: 3151A1-1205
B2061001
First Submitted: August 3, 2009
First Posted: August 6, 2009
Results First Submitted: July 6, 2011
Results First Posted: August 2, 2011
Last Update Posted: August 15, 2011