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Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00824291
Recruitment Status : Completed
First Posted : January 16, 2009
Results First Posted : November 25, 2010
Last Update Posted : March 10, 2011
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depressive Disorder, Major
Interventions Drug: desvenlafaxine succinate sustained release
Genetic: Genotyping
Enrollment 437
Recruitment Details A total of 752 potential participants were screened for this study. 437 participants were randomized to treatment groups while 315 participants were not randomized (288: did not meet the study criteria; 27 were not randomized for other reasons). Of the 437 randomized participants, 10 participants did not receive the study treatment.
Pre-assignment Details  
Arm/Group Title DVS SR 50 mg Placebo
Hide Arm/Group Description Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food. Participants were administered an oral dose of placebo once daily with or without food.
Period Title: Overall Study
Started 285 142
Completed 231 107
Not Completed 54 35
Reason Not Completed
Adverse Event             15             6
Discontinuation of Study by Sponsor             1             2
Lost to Follow-up             11             9
Non-compliance             1             1
Protocol Violation             4             1
Withdrawal by Subject             14             8
Lack of Efficacy             7             8
Participant on prohibited medication             1             0
Arm/Group Title DVS SR 50 mg Placebo Total
Hide Arm/Group Description Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food. Participants were administered an oral dose of placebo once daily with or without food. Total of all reporting groups
Overall Number of Baseline Participants 285 142 427
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 285 participants 142 participants 427 participants
43.16  (11.72) 41.57  (12.64) 42.63  (12.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 285 participants 142 participants 427 participants
Female
188
  66.0%
93
  65.5%
281
  65.8%
Male
97
  34.0%
49
  34.5%
146
  34.2%
1.Primary Outcome
Title Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12
Hide Description HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline.
Time Frame At Baseline and Week 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set, Last Observation Carried Forward (LOCF)
Arm/Group Title DVS SR 50 mg Placebo
Hide Arm/Group Description:
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
Participants were administered an oral dose of placebo once daily with or without food.
Overall Number of Participants Analyzed 285 142
Mean (Standard Error)
Unit of Measure: Scores on a scale
-12.61  (0.45) -10.50  (0.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS SR 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.12
Confidence Interval (2-Sided) 95%
0.78 to 3.46
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12
Hide Description Participant rated scale was used to assess the effect of the participant’s symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant’s work/social/family life. Individual item scores range from 0 to 10.
Time Frame At Baseline and Week 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title DVS SR 50 mg Placebo
Hide Arm/Group Description:
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
Participants were administered an oral dose of placebo once daily with or without food.
Overall Number of Participants Analyzed 285 142
Mean (Standard Error)
Unit of Measure: Scores on a scale
-9.41  (0.48) -8.08  (0.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS SR 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.067
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
-0.09 to 2.76
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12
Hide Description CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Change = score at observation minus score at baseline.
Time Frame At Baseline and Week 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title DVS SR 50 mg Placebo
Hide Arm/Group Description:
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
Participants were administered an oral dose of placebo once daily with or without food.
Overall Number of Participants Analyzed 285 142
Measure Type: Number
Unit of Measure: Scores on a scale
1 (Very Much Improved) 103 31
2 (Much Improved) 84 44
3 (Minimally Improved) 53 31
4 (No Change) 34 30
5 (Minimally Worse) 10 5
6 (Much Worse) 0 1
7 (Very Much Worse) 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS SR 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12
Hide Description CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.
Time Frame At Baseline and Week 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title DVS SR 50 mg Placebo
Hide Arm/Group Description:
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
Participants were administered an oral dose of placebo once daily with or without food.
Overall Number of Participants Analyzed 285 142
Measure Type: Number
Unit of Measure: Scores on a scale
1 (Very Much Improved) 69 23
2 (Much Improved) 68 30
3 (Minimally Improved) 77 31
4 (No Change) 56 43
5 (Minimally Worse) 14 15
6 (Much Worse) 1 0
7 (Very Much Worse) 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS SR 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline on Work and Activities Item of HAM-D17 at Week 12
Hide Description The Work and Activities Item of the HAM-D17 is item 7 of HAM-D17. Scoring range from 0 to 4.
Time Frame At Baseline and Week 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title DVS SR 50 mg Placebo
Hide Arm/Group Description:
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
Participants were administered an oral dose of placebo once daily with or without food.
Overall Number of Participants Analyzed 285 142
Mean (Standard Error)
Unit of Measure: Scores on a scale
-1.68  (0.07) -1.45  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS SR 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.23
Confidence Interval (2-Sided) 95%
0.01 to 0.44
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12
Hide Description Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Time Frame At Baseline and Week 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title DVS SR 50 mg Placebo
Hide Arm/Group Description:
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
Participants were administered an oral dose of placebo once daily with or without food.
Overall Number of Participants Analyzed 265 125
Mean (Standard Error)
Unit of Measure: Scores on a scale
-18.44  (0.69) -16.18  (0.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS SR 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.26
Confidence Interval (2-Sided) 95%
0.16 to 4.37
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12
Hide Description WATS: a self-administered, 3-question rating scale assesses worry, anxiety, and tension. Each item was a visual analog scale on which the participant circles a number from 0 to 10. Higher scores indicated worse function. WATS total score was the sum of the 3 items. If 1 item was missing, the total score would be missing.
Time Frame At Baseline and Week 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title DVS SR 50 mg Placebo
Hide Arm/Group Description:
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
Participants were administered an oral dose of placebo once daily with or without food.
Overall Number of Participants Analyzed 285 142
Mean (Standard Error)
Unit of Measure: Scores on a scale
-13.39  (0.79) -10.95  (1.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS SR 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.44
Confidence Interval (2-Sided) 95%
0.10 to 4.78
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline on Stress and Social Support Scales at Week 12
Hide Description Stress and Social Support Scales: self-administered rating scale where item 1 is the stress vulnerability scale measuring how much the subject was set back by stressful events on an 11-point scale ranging from 0 (not at all) to 10 (extremely) and item 2 is an 11-point scale ranging from 0 to 100 percent of the amount of support the subject received from relatives and friends.
Time Frame At Baseline and Week 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT, LOCF
Arm/Group Title DVS SR 50 mg Placebo
Hide Arm/Group Description:
Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
Participants were administered an oral dose of placebo once daily with or without food.
Overall Number of Participants Analyzed 285 142
Mean (Standard Error)
Unit of Measure: Scores on a scale
-2.53  (0.18) -2.14  (0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS SR 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.145
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
-0.13 to 0.91
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DVS SR 50 mg Placebo
Hide Arm/Group Description Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food. Participants were administered an oral dose of placebo once daily with or without food.
All-Cause Mortality
DVS SR 50 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DVS SR 50 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/285 (0.70%)   2/142 (1.41%) 
Injury, poisoning and procedural complications     
Road traffic accident  1  0/285 (0.00%)  1/142 (0.70%) 
Nervous system disorders     
Amnesia  1  1/285 (0.35%)  0/142 (0.00%) 
Cerebrovascular disorder  1  0/285 (0.00%)  1/142 (0.70%) 
Psychiatric disorders     
Major depression  1  1/285 (0.35%)  0/142 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/285 (0.00%)  1/142 (0.70%) 
Bronchitis  1  0/285 (0.00%)  1/142 (0.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DVS SR 50 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   213/285 (74.74%)   90/142 (63.38%) 
Blood and lymphatic system disorders     
Anemia  1  1/285 (0.35%)  1/142 (0.70%) 
Leukopenia  1  1/285 (0.35%)  0/142 (0.00%) 
Cardiac disorders     
Palpitations  1  5/285 (1.75%)  1/142 (0.70%) 
Sinus bradycardia  1  1/285 (0.35%)  0/142 (0.00%) 
Tachycardia  1  1/285 (0.35%)  1/142 (0.70%) 
Ear and labyrinth disorders     
Ear congestion  1  0/285 (0.00%)  1/142 (0.70%) 
Tinnitus  1  3/285 (1.05%)  1/142 (0.70%) 
Vertigo  1  1/285 (0.35%)  0/142 (0.00%) 
Endocrine disorders     
Hypothyroidism  1  1/285 (0.35%)  0/142 (0.00%) 
Eye disorders     
Blepharospasm  1  1/285 (0.35%)  0/142 (0.00%) 
Contact lens intolerance  1  1/285 (0.35%)  0/142 (0.00%) 
Eyelid ptosis  1  1/285 (0.35%)  0/142 (0.00%) 
Mydriasis  1  1/285 (0.35%)  0/142 (0.00%) 
Photopsia  1  0/285 (0.00%)  1/142 (0.70%) 
Vision blurred  1  1/285 (0.35%)  2/142 (1.41%) 
Visual impairment  1  1/285 (0.35%)  0/142 (0.00%) 
Gastrointestinal disorders     
Abdominal discomfort  1  2/285 (0.70%)  1/142 (0.70%) 
Abdominal pain  1  0/285 (0.00%)  1/142 (0.70%) 
Abdominal pain upper  1  4/285 (1.40%)  1/142 (0.70%) 
Constipation  1  18/285 (6.32%)  11/142 (7.75%) 
Diarrhea  1  18/285 (6.32%)  10/142 (7.04%) 
Dry mouth  1  48/285 (16.84%)  9/142 (6.34%) 
Dyspepsia  1  4/285 (1.40%)  2/142 (1.41%) 
Eructation  1  2/285 (0.70%)  1/142 (0.70%) 
Flatulence  1  3/285 (1.05%)  6/142 (4.23%) 
Food poisoning  1  1/285 (0.35%)  1/142 (0.70%) 
Gastrooesophageal reflux disease  1  1/285 (0.35%)  0/142 (0.00%) 
Nausea  1  56/285 (19.65%)  8/142 (5.63%) 
Toothache  1  1/285 (0.35%)  1/142 (0.70%) 
Vomiting  1  6/285 (2.11%)  4/142 (2.82%) 
General disorders     
Asthenia  1  3/285 (1.05%)  1/142 (0.70%) 
Facial pain  1  1/285 (0.35%)  0/142 (0.00%) 
Fatigue  1  16/285 (5.61%)  5/142 (3.52%) 
Feeling abnormal  1  0/285 (0.00%)  1/142 (0.70%) 
Feeling drunk  1  0/285 (0.00%)  1/142 (0.70%) 
Feeling jittery  1  5/285 (1.75%)  0/142 (0.00%) 
Influenza like illness  1  1/285 (0.35%)  1/142 (0.70%) 
Irritability  1  3/285 (1.05%)  4/142 (2.82%) 
Non-cardiac chest pain  1  0/285 (0.00%)  1/142 (0.70%) 
Edema peripheral  1  2/285 (0.70%)  1/142 (0.70%) 
Pyrexia  1  2/285 (0.70%)  0/142 (0.00%) 
Thirst  1  1/285 (0.35%)  0/142 (0.00%) 
Vaginal infection  1  1/285 (0.35%)  0/142 (0.00%) 
Immune system disorders     
Seasonal allergy  1  1/285 (0.35%)  1/142 (0.70%) 
Infections and infestations     
Bronchitis  1  2/285 (0.70%)  2/142 (1.41%) 
Cystitis  1  1/285 (0.35%)  1/142 (0.70%) 
Ear infection  1  2/285 (0.70%)  0/142 (0.00%) 
Fungal infection  1  1/285 (0.35%)  0/142 (0.00%) 
Gastroenteritis  1  1/285 (0.35%)  1/142 (0.70%) 
Gastroenteritis viral  1  2/285 (0.70%)  0/142 (0.00%) 
Giardiasis  1  1/285 (0.35%)  0/142 (0.00%) 
Herpes simplex  1  1/285 (0.35%)  0/142 (0.00%) 
Influenza  1  3/285 (1.05%)  2/142 (1.41%) 
Nasopharyngitis  1  5/285 (1.75%)  3/142 (2.11%) 
Otitis media  1  1/285 (0.35%)  0/142 (0.00%) 
Pharyngitis  1  1/285 (0.35%)  1/142 (0.70%) 
Pharyngitis bacterial  1  1/285 (0.35%)  0/142 (0.00%) 
Pneumonia  1  1/285 (0.35%)  0/142 (0.00%) 
Pneumonia primary atypical  1  1/285 (0.35%)  0/142 (0.00%) 
Tooth abscess  1  1/285 (0.35%)  1/142 (0.70%) 
Tooth infection  1  0/285 (0.00%)  1/142 (0.70%) 
Upper respiratory tract infection  1  7/285 (2.46%)  2/142 (1.41%) 
Urinary tract infection  1  2/285 (0.70%)  2/142 (1.41%) 
Vulvovaginal candidiasis  1  1/285 (0.35%)  0/142 (0.00%) 
Sinusitis  1  1/285 (0.35%)  0/142 (0.00%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  7/285 (2.46%)  4/142 (2.82%) 
Burns second degree  1  1/285 (0.35%)  0/142 (0.00%) 
Contusion * 1  2/285 (0.70%)  0/142 (0.00%) 
Fall  1  1/285 (0.35%)  0/142 (0.00%) 
Foot fracture  1  2/285 (0.70%)  0/142 (0.00%) 
Heat exhaustion  1  1/285 (0.35%)  0/142 (0.00%) 
Injury  1  1/285 (0.35%)  0/142 (0.00%) 
Joint dislocation  1  1/285 (0.35%)  0/142 (0.00%) 
Joint sprain  1  0/285 (0.00%)  1/142 (0.70%) 
Limb injury  1  1/285 (0.35%)  0/142 (0.00%) 
Muscle injury  1  1/285 (0.35%)  0/142 (0.00%) 
Procedural pain  1  0/285 (0.00%)  2/142 (1.41%) 
Road traffic accident  1  1/285 (0.35%)  1/142 (0.70%) 
Sunburn  1  0/285 (0.00%)  1/142 (0.70%) 
Thermal burn  1  1/285 (0.35%)  0/142 (0.00%) 
Investigations     
Blood cholesterol increased  1  0/285 (0.00%)  1/142 (0.70%) 
Blood pressure increased  1  2/285 (0.70%)  2/142 (1.41%) 
Blood pressure systolic increased  1  1/285 (0.35%)  0/142 (0.00%) 
Blood triglycerides increased  1  1/285 (0.35%)  1/142 (0.70%) 
Electrocardiogram QT prolonged  1  0/285 (0.00%)  1/142 (0.70%) 
Gamma-glutamyltransferase increased  1  1/285 (0.35%)  1/142 (0.70%) 
Heart rate increased  1  1/285 (0.35%)  1/142 (0.70%) 
Low density lipoprotein increased  1  0/285 (0.00%)  1/142 (0.70%) 
Thyroxine free decreased  1  1/285 (0.35%)  0/142 (0.00%) 
Transaminases increased  1  1/285 (0.35%)  0/142 (0.00%) 
Weight decreased  1  2/285 (0.70%)  2/142 (1.41%) 
Weight increased  1  4/285 (1.40%)  4/142 (2.82%) 
White blood cell count increased  1  1/285 (0.35%)  0/142 (0.00%) 
Tri-iodothyronine decreased  1  1/285 (0.35%)  0/142 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  10/285 (3.51%)  2/142 (1.41%) 
Gout  1  1/285 (0.35%)  0/142 (0.00%) 
Hyperglycemia  1  1/285 (0.35%)  0/142 (0.00%) 
Hyperlipidemia  1  0/285 (0.00%)  1/142 (0.70%) 
Hypoglycemia  1  1/285 (0.35%)  0/142 (0.00%) 
Increased appetite  1  3/285 (1.05%)  2/142 (1.41%) 
Arthralgia  1  2/285 (0.70%)  2/142 (1.41%) 
Back pain  1  10/285 (3.51%)  2/142 (1.41%) 
Bursitis  1  1/285 (0.35%)  0/142 (0.00%) 
Flank pain  1  1/285 (0.35%)  1/142 (0.70%) 
Joint stiffness  1  1/285 (0.35%)  1/142 (0.70%) 
Joint swelling  1  2/285 (0.70%)  2/142 (1.41%) 
Muscle spasms  1  4/285 (1.40%)  1/142 (0.70%) 
Musculoskeletal and connective tissue disorders     
Muscle tightness  1  1/285 (0.35%)  0/142 (0.00%) 
Muscle twitching  1  1/285 (0.35%)  0/142 (0.00%) 
Musculoskeletal chest pain  1  2/285 (0.70%)  1/142 (0.70%) 
Musculoskeletal pain  1  0/285 (0.00%)  2/142 (1.41%) 
Myalgia  1  2/285 (0.70%)  0/142 (0.00%) 
Neck pain  1  2/285 (0.70%)  1/142 (0.70%) 
Pain in extremity  1  1/285 (0.35%)  1/142 (0.70%) 
Sensation of heaviness  1  1/285 (0.35%)  0/142 (0.00%) 
Nervous system disorders     
Aphasia  1  1/285 (0.35%)  0/142 (0.00%) 
Burning sensation  1  1/285 (0.35%)  0/142 (0.00%) 
Crying  1  0/285 (0.00%)  1/142 (0.70%) 
Disturbance in attention  1  3/285 (1.05%)  0/142 (0.00%) 
Dizziness  1  28/285 (9.82%)  6/142 (4.23%) 
Dizziness postural  1  0/285 (0.00%)  2/142 (1.41%) 
Dysgeusia  1  1/285 (0.35%)  0/142 (0.00%) 
Fine motor delay  1  1/285 (0.35%)  0/142 (0.00%) 
Headache  1  43/285 (15.09%)  21/142 (14.79%) 
Hypersomnia  1  0/285 (0.00%)  1/142 (0.70%) 
Hypoaesthesia  1  1/285 (0.35%)  0/142 (0.00%) 
Lethargy  1  2/285 (0.70%)  0/142 (0.00%) 
Migraine  1  4/285 (1.40%)  2/142 (1.41%) 
Paresthesia  1  5/285 (1.75%)  1/142 (0.70%) 
Presyncope  1  1/285 (0.35%)  0/142 (0.00%) 
Sedation  1  4/285 (1.40%)  0/142 (0.00%) 
Sinus headache  1  2/285 (0.70%)  0/142 (0.00%) 
Somnolence  1  18/285 (6.32%)  3/142 (2.11%) 
Syncope  1  1/285 (0.35%)  1/142 (0.70%) 
Tension headache  1  1/285 (0.35%)  0/142 (0.00%) 
Tremor  1  5/285 (1.75%)  0/142 (0.00%) 
Psychiatric disorders     
Abnormal dreams  1  2/285 (0.70%)  3/142 (2.11%) 
Anorgasmia  1  1/285 (0.35%)  0/142 (0.00%) 
Anxiety  1  4/285 (1.40%)  1/142 (0.70%) 
Bereavement reaction  1  1/285 (0.35%)  0/142 (0.00%) 
Bruxism  1  2/285 (0.70%)  0/142 (0.00%) 
Depression  1  2/285 (0.70%)  0/142 (0.00%) 
Euphoric mood  1  1/285 (0.35%)  0/142 (0.00%) 
Initial insomnia  1  2/285 (0.70%)  0/142 (0.00%) 
Insomnia  1  13/285 (4.56%)  5/142 (3.52%) 
Libido decreased  1  5/285 (1.75%)  0/142 (0.00%) 
Libido increased  1  1/285 (0.35%)  0/142 (0.00%) 
Major depression  1  0/285 (0.00%)  1/142 (0.70%) 
Middle insomnia  1  2/285 (0.70%)  0/142 (0.00%) 
Nervousness  1  1/285 (0.35%)  1/142 (0.70%) 
Panic attack  1  1/285 (0.35%)  0/142 (0.00%) 
Restlessness  1  0/285 (0.00%)  1/142 (0.70%) 
Sleep disorder  1  1/285 (0.35%)  0/142 (0.00%) 
Violence-related symptom  1  0/285 (0.00%)  1/142 (0.70%) 
Pollakiuria  1  2/285 (0.70%)  1/142 (0.70%) 
Renal and urinary disorders     
Nephrolithiasis  1  0/285 (0.00%)  1/142 (0.70%) 
Reproductive system and breast disorders     
Breast discharge  1  0/285 (0.00%)  1/142 (0.70%) 
Breast tenderness  1  1/285 (0.35%)  0/142 (0.00%) 
Dysmenorrhea  1  0/285 (0.00%)  1/142 (0.70%) 
Ejaculation delayed  1  2/285 (0.70%)  0/142 (0.00%) 
Erectile dysfunction  1  4/285 (1.40%)  1/142 (0.70%) 
Menorrhagia  1  0/285 (0.00%)  1/142 (0.70%) 
Menstruation irregular  1  2/285 (0.70%)  1/142 (0.70%) 
Metrorrhagia  1  1/285 (0.35%)  0/142 (0.00%) 
Sexual dysfunction  1  1/285 (0.35%)  0/142 (0.00%) 
Vaginal discharge  1  1/285 (0.35%)  0/142 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/285 (0.35%)  3/142 (2.11%) 
Dry throat  1  1/285 (0.35%)  0/142 (0.00%) 
Dysphonia  1  1/285 (0.35%)  0/142 (0.00%) 
Dyspnea  1  0/285 (0.00%)  1/142 (0.70%) 
Epistaxis  1  0/285 (0.00%)  1/142 (0.70%) 
Nasal congestion  1  1/285 (0.35%)  0/142 (0.00%) 
Oropharyngeal pain  1  1/285 (0.35%)  0/142 (0.00%) 
Sinus congestion  1  3/285 (1.05%)  0/142 (0.00%) 
Upper respiratory tract congestion  1  0/285 (0.00%)  1/142 (0.70%) 
Yawning  1  5/285 (1.75%)  0/142 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  0/285 (0.00%)  1/142 (0.70%) 
Dermatitis contact  1  3/285 (1.05%)  0/142 (0.00%) 
Ecchymosis  1  0/285 (0.00%)  1/142 (0.70%) 
Erythema  1  0/285 (0.00%)  1/142 (0.70%) 
Hyperhidrosis  1  4/285 (1.40%)  0/142 (0.00%) 
Night sweats  1  2/285 (0.70%)  1/142 (0.70%) 
Pruritus  1  2/285 (0.70%)  0/142 (0.00%) 
Rash  1  3/285 (1.05%)  1/142 (0.70%) 
Vascular disorders     
Hot flush  1  4/285 (1.40%)  2/142 (1.41%) 
Hypertension  1  9/285 (3.16%)  0/142 (0.00%) 
Hypotension  1  0/285 (0.00%)  1/142 (0.70%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc
Phone: 1-800-718-1021
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00824291     History of Changes
Other Study ID Numbers: 3151A1-4415
B2061006
First Submitted: January 14, 2009
First Posted: January 16, 2009
Results First Submitted: October 26, 2010
Results First Posted: November 25, 2010
Last Update Posted: March 10, 2011