Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in Major Depressive Disorder (MDD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00831415
Recruitment Status : Completed
First Posted : January 29, 2009
Results First Posted : January 30, 2012
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Drug: desvenlafaxine succinate sustained release tablets
Enrollment 304
Recruitment Details This was a 10-month, open-label, multicenter study of Japanese participants with Major Depressive Disorder (MDD) conducted from March 2009 to March 2011 at 61 sites in Japan.
Pre-assignment Details A total of 304 participants who completed the short-term Core Study (NCT00798707 [3151A1-3359 / B2061003]) consented to enroll in this long-term, open-label, flexible dosing Extension study (NCT00831415 [3151A1-3350 / B2061002]). Baseline in this Extension study = Day 56 of the Core study.
Arm/Group Title DVS SR
Hide Arm/Group Description Desvenlafaxine succinate sustained release formulation (DVS SR) flexible dose 25 milligrams per day (mg/day) up to 100 mg/day.
Period Title: Overall Study
Started 304
Completers for "Exposure" 227 [1]
Study "Completers" 227 [2]
Completed 229 [3]
Not Completed 75
Reason Not Completed
Adverse Event             14
Failed to return             3
Physician Decision             6
Lost to Follow-up             9
Protocol Violation             3
Withdrawal by Subject             35
Unsatisfactory response - Efficacy             4
Death             1
[1]
Participants with ≥ 301 days of exposure to study drug and completed study day 308 evaluations.
[2]
Defined as participants whose conclusion of study participation status was “study completed.”
[3]
In addition to Completers for Study includes 2 participants who discontinued after on-therapy period
Arm/Group Title DVS SR
Hide Arm/Group Description DVS SR flexible dose 25 mg/day up to 100 mg/day.
Overall Number of Baseline Participants 304
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 304 participants
38.45  (10.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 304 participants
Female
149
  49.0%
Male
155
  51.0%
Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 304 participants
12.86  (6.30)
[1]
Measure Description: HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4) with 0=none/absent and 4=most severe, for a maximum total score of 50. Higher scores indicate greater severity.
Categorical scores on Clinical Global Impression-Improvement [CGI-I]   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 304 participants
1=Very much improved 75
2=Much improved 81
3=Minimally improved 94
4=No change 51
5=Minimally worse 3
[1]
Measure Description: CGI-I is a 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. Baseline for CGI-I in this Extension study (NCT00831415 [3151A1-3350 / B2061002]) was measured against CGI-I baseline (Day -1) data in Core study (NCT00798707 [3151A1-3359 / B2061003]).
Clinical Global Impression-Severity of Illness [CGI-S] score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 304 participants
3.25  (1.11)
[1]
Measure Description: CGI-S is a 7-point clinician rated scale to assess severity of current illness state. Range is 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected.
1.Primary Outcome
Title Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score
Hide Description HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4) with 0=none/absent and 4=most severe, for a maximum total score of 50. Higher scores indicate greater severity. FOT evaluation is defined as the last "on-therapy" evaluation, regardless of the number of days on therapy. Analysis on Observed cases (non-missing data) and Last observation carried forward (LOCF); LOCF method of imputation for any missing value at any visit.
Time Frame Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT): all enrolled participants who received at least 1 dose of study treatment in Extension Study and at least 1 available post-baseline evaluation for any endpoint; (n)=number of participants with analyzable data at observation.
Arm/Group Title DVS SR
Hide Arm/Group Description:
DVS SR flexible dose 25 mg/day up to 100 mg/day.
Overall Number of Participants Analyzed 304
Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
LOCF - change at FOT (n=304)
-4.76
(-5.47 to -4.05)
Observed cases - change at Day 308 (n=224)
-5.82
(-6.61 to -5.03)
2.Primary Outcome
Title Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Hide Description Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be an SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.
Time Frame Baseline (Extension Study) up to Day 329 or 15 days after last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all enrolled participants who received at least 1 dose of study treatment in this extension study.
Arm/Group Title DVS SR
Hide Arm/Group Description:
DVS SR flexible dose 25 mg/day up to 100 mg/day.
Overall Number of Participants Analyzed 304
Measure Type: Number
Unit of Measure: percentage of participants
Adverse Events 81.3
Serious Adverse Events 2.6
3.Secondary Outcome
Title Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I)
Hide Description CGI-I is a 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.
Time Frame Day 308 or FOT Evaluation
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; LOCF. Improvement measured against CGI-I baseline (Day -1) data in Core study (NCT00798707 [3151A1-3359 / B2061003]).
Arm/Group Title DVS SR
Hide Arm/Group Description:
DVS SR flexible dose 25 mg/day up to 100 mg/day.
Overall Number of Participants Analyzed 304
Measure Type: Number
Unit of Measure: participants
1=Very much improved 164
2=Much improved 82
3=Minimally improved 36
4=No change 15
5=Minimally worse 6
6=Much worse 1
7=Very much worse 0
4.Secondary Outcome
Title Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score
Hide Description CGI-S is a 7-point clinician rated scale to assess severity of current illness state. Range is 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected.
Time Frame Baseline (Extension Study) up to Day 308 or FOT Evaluation
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; LOCF and Observed cases (non-missing data); (n)=number of participants with analyzable data at observation.
Arm/Group Title DVS SR
Hide Arm/Group Description:
DVS SR flexible dose 25 mg/day up to 100 mg/day.
Overall Number of Participants Analyzed 304
Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
LOCF - change at FOT (n=304)
-0.82
(-0.94 to -0.70)
Observed cases - change at Day 308 (n=224)
-0.95
(-1.09 to -0.80)
Time Frame Events were collected from the time of the signing of the informed consent form up to 15 days after the last dose of study treatment was administered.
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 DVS SR
Hide Arm/Group Description DVS SR flexible dose 25 mg/day up to 100 mg/day.
All-Cause Mortality
DVS SR
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DVS SR
Affected / at Risk (%)
Total   8/304 (2.63%) 
Infections and infestations   
Gastroenteritis  1  1/304 (0.33%) 
Infectious mononucleosis  1  1/304 (0.33%) 
Injury, poisoning and procedural complications   
Contusion  1  1/304 (0.33%) 
Metabolism and nutrition disorders   
Diabetes mellitus  1  1/304 (0.33%) 
Musculoskeletal and connective tissue disorders   
Intervertebral disc protrusion  1  1/304 (0.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Large intestine carcinoma  1  1/304 (0.33%) 
Psychiatric disorders   
Completed suicide  1  1/304 (0.33%) 
Respiratory, thoracic and mediastinal disorders   
Sleep apnoea syndrome  1  1/304 (0.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DVS SR
Affected / at Risk (%)
Total   247/304 (81.25%) 
Blood and lymphatic system disorders   
Anaemia  1  1/304 (0.33%) 
Iron deficiency anaemia  1  1/304 (0.33%) 
Leukopenia  1  1/304 (0.33%) 
Lymphadenitis  1  1/304 (0.33%) 
Lymphadenopathy  1  1/304 (0.33%) 
Neutropenia  1  1/304 (0.33%) 
Cardiac disorders   
Atrioventricular block first degree  1  1/304 (0.33%) 
Palpitations  1  6/304 (1.97%) 
Ventricular extrasystoles  1  1/304 (0.33%) 
Ear and labyrinth disorders   
Ear pain  1  1/304 (0.33%) 
Meniere’s disease  1  2/304 (0.66%) 
Motion sickness  1  1/304 (0.33%) 
Tinnitus  1  12/304 (3.95%) 
Vertigo  1  5/304 (1.64%) 
Eye disorders   
Blepharospasm  1  1/304 (0.33%) 
Cataract  1  1/304 (0.33%) 
Conjunctivitis  1  1/304 (0.33%) 
Conjunctivitis allergic  1  1/304 (0.33%) 
Eye pain  1  1/304 (0.33%) 
Lacrimation increased  1  1/304 (0.33%) 
Retinal vein occlusion  1  1/304 (0.33%) 
Vision blurred  1  1/304 (0.33%) 
Vitreous floaters  1  1/304 (0.33%) 
Gastrointestinal disorders   
Abdominal discomfort  1  10/304 (3.29%) 
Abdominal distension  1  2/304 (0.66%) 
Abdominal pain  1  6/304 (1.97%) 
Abdominal pain lower  1  3/304 (0.99%) 
Abdominal pain upper  1  20/304 (6.58%) 
Aphthous stomatitis  1  3/304 (0.99%) 
Cheilitis  1  2/304 (0.66%) 
Constipation  1  17/304 (5.59%) 
Dental caries  1  9/304 (2.96%) 
Diarrhoea  1  29/304 (9.54%) 
Dry mouth  1  6/304 (1.97%) 
Dyspepsia  1  3/304 (0.99%) 
Enterocolitis  1  1/304 (0.33%) 
Flatulence  1  3/304 (0.99%) 
Food poisoning  1  1/304 (0.33%) 
Gastritis  1  6/304 (1.97%) 
Gastrointestinal disorder  1  3/304 (0.99%) 
Gastrointestinal sounds abnormal  1  1/304 (0.33%) 
Gastrooesophageal reflux disease  1  1/304 (0.33%) 
Glossitis  1  1/304 (0.33%) 
Haemorrhoidal haemorrhage  1  1/304 (0.33%) 
Haemorrhoids  1  2/304 (0.66%) 
Irritable bowel syndrome  1  1/304 (0.33%) 
Nausea  1  38/304 (12.50%) 
Oral discomfort  1  2/304 (0.66%) 
Oral pain  1  1/304 (0.33%) 
Stomatitis  1  6/304 (1.97%) 
Toothache  1  4/304 (1.32%) 
Vomiting  1  8/304 (2.63%) 
General disorders   
Chills  1  2/304 (0.66%) 
Condition aggravated  1  1/304 (0.33%) 
Device dislocation  1  1/304 (0.33%) 
Drug withdrawal syndrome  1  7/304 (2.30%) 
Eye complication associated with device  1  1/304 (0.33%) 
Fatigue  1  4/304 (1.32%) 
Feeling abnormal  1  6/304 (1.97%) 
Feeling hot  1  1/304 (0.33%) 
Hangover  1  1/304 (0.33%) 
Irritability  1  3/304 (0.99%) 
Malaise  1  8/304 (2.63%) 
Oedema  1  2/304 (0.66%) 
Oedema peripheral  1  1/304 (0.33%) 
Pyrexia  1  4/304 (1.32%) 
Thirst  1  10/304 (3.29%) 
Hepatobiliary disorders   
Gallbladder polyp  1  1/304 (0.33%) 
Hepatic function abnormal  1  1/304 (0.33%) 
Hepatic steatosis  1  1/304 (0.33%) 
Immune system disorders   
Allergy to arthropod sting  1  1/304 (0.33%) 
Drug hypersensitivity  1  1/304 (0.33%) 
Seasonal allergy  1  2/304 (0.66%) 
Infections and infestations   
Acute sinusitis  1  1/304 (0.33%) 
Adenoviral conjunctivitis  1  1/304 (0.33%) 
Body tinea  1  1/304 (0.33%) 
Bronchitis  1  1/304 (0.33%) 
Cystitis  1  1/304 (0.33%) 
Enteritis infectious  1  2/304 (0.66%) 
Gastroenteritis  1  9/304 (2.96%) 
Gastroenteritis viral  1  1/304 (0.33%) 
Helicobacter infection  1  1/304 (0.33%) 
Herpangina  1  1/304 (0.33%) 
Herpes simplex  1  1/304 (0.33%) 
Herpes virus infection  1  2/304 (0.66%) 
Herpes zoster  1  1/304 (0.33%) 
Hordeolum  1  2/304 (0.66%) 
Influenza  1  7/304 (2.30%) 
Laryngitis  1  1/304 (0.33%) 
Nasopharyngitis  1  122/304 (40.13%) 
Oral herpes  1  3/304 (0.99%) 
Otitis externa  1  1/304 (0.33%) 
Otitis media  1  1/304 (0.33%) 
Paronychia  1  2/304 (0.66%) 
Parotitis  1  1/304 (0.33%) 
Periodontal infection  1  1/304 (0.33%) 
Pharyngitis  1  5/304 (1.64%) 
Rhinitis  1  2/304 (0.66%) 
Tinea infection  1  1/304 (0.33%) 
Tinea pedis  1  1/304 (0.33%) 
Tonsillitis  1  1/304 (0.33%) 
Injury, poisoning and procedural complications   
Arthropod bite  1  1/304 (0.33%) 
Arthropod sting  1  1/304 (0.33%) 
Bone fissure  1  1/304 (0.33%) 
Chillblains  1  1/304 (0.33%) 
Contusion  1  9/304 (2.96%) 
Excoriation  1  2/304 (0.66%) 
Fall  1  2/304 (0.66%) 
Head injury  1  1/304 (0.33%) 
Heat illness  1  2/304 (0.66%) 
Heat stroke  1  1/304 (0.33%) 
Injury corneal  1  2/304 (0.66%) 
Intentional overdose  1  1/304 (0.33%) 
Joint sprain  1  4/304 (1.32%) 
Laceration  1  2/304 (0.66%) 
Meniscus lesion  1  1/304 (0.33%) 
Mouth injury  1  1/304 (0.33%) 
Muscle strain  1  1/304 (0.33%) 
Road traffic accident  1  1/304 (0.33%) 
Thermal burn  1  1/304 (0.33%) 
Whiplash injury  1  1/304 (0.33%) 
Investigations   
Alanine aminotransferase increased  1  9/304 (2.96%) 
Aspartate aminotransferase increased  1  5/304 (1.64%) 
Blood alkaline phosphatase increased  1  2/304 (0.66%) 
Blood bilirubin increased  1  1/304 (0.33%) 
Blood creatine phosphokinase increased  1  1/304 (0.33%) 
Blood glucose increased  1  2/304 (0.66%) 
Blood potassium decreased  1  1/304 (0.33%) 
Blood pressure diastolic increased  1  1/304 (0.33%) 
Blood pressure increased  1  6/304 (1.97%) 
Blood prolactin increased  1  7/304 (2.30%) 
Blood triglycerides increased  1  7/304 (2.30%) 
Blood uric acid increased  1  4/304 (1.32%) 
Blood urine present  1  2/304 (0.66%) 
Electrocardiogram QT prolonged  1  1/304 (0.33%) 
Gamma−glutamyltransferase increased  1  8/304 (2.63%) 
Glucose urine present  1  2/304 (0.66%) 
Haematocrit decreased  1  1/304 (0.33%) 
Haemoglobin decreased  1  1/304 (0.33%) 
Lipids abnormal  1  1/304 (0.33%) 
Lipids increased  1  1/304 (0.33%) 
Liver function test abnormal  1  6/304 (1.97%) 
Neutrophil count decreased  1  1/304 (0.33%) 
Occult blood positive  1  1/304 (0.33%) 
Platelet count decreased  1  1/304 (0.33%) 
Protein urine present  1  3/304 (0.99%) 
Red blood cell count decreased  1  2/304 (0.66%) 
Urine ketone body present  1  1/304 (0.33%) 
Weight decreased  1  1/304 (0.33%) 
Weight increased  1  19/304 (6.25%) 
White blood cell count decreased  1  3/304 (0.99%) 
White blood cell count increased  1  1/304 (0.33%) 
Metabolism and nutrition disorders   
Decreased appetite  1  3/304 (0.99%) 
Dehydration  1  1/304 (0.33%) 
Hyperlipidaemia  1  2/304 (0.66%) 
Hyperphagia  1  2/304 (0.66%) 
Increased appetite  1  2/304 (0.66%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  6/304 (1.97%) 
Back pain  1  17/304 (5.59%) 
Intervertebral disc protrusion  1  1/304 (0.33%) 
Joint stiffness  1  1/304 (0.33%) 
Lumbar spinal stenosis  1  1/304 (0.33%) 
Muscle spasms  1  1/304 (0.33%) 
Muscle tightness  1  1/304 (0.33%) 
Muscular weakness  1  1/304 (0.33%) 
Musculoskeletal chest pain  1  1/304 (0.33%) 
Musculoskeletal pain  1  1/304 (0.33%) 
Musculoskeletal stiffness  1  8/304 (2.63%) 
Myalgia  1  2/304 (0.66%) 
Neck pain  1  4/304 (1.32%) 
Pain in extremity  1  1/304 (0.33%) 
Pain in jaw  1  1/304 (0.33%) 
Periarthritis  1  3/304 (0.99%) 
Scoliosis  1  1/304 (0.33%) 
Temporomandibular joint syndrome  1  1/304 (0.33%) 
Trigger finger  1  1/304 (0.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Haemangioma of liver  1  1/304 (0.33%) 
Skin papilloma  1  1/304 (0.33%) 
Uterine leiomyoma  1  1/304 (0.33%) 
Nervous system disorders   
Autonomic nervous system imbalance  1  1/304 (0.33%) 
Dizziness  1  36/304 (11.84%) 
Dizziness postural  1  10/304 (3.29%) 
Dysgeusia  1  3/304 (0.99%) 
Headache  1  36/304 (11.84%) 
Hypoaesthesia  1  6/304 (1.97%) 
Intercostal neuralgia  1  1/304 (0.33%) 
Irregular sleep phase  1  1/304 (0.33%) 
Memory impairment  1  1/304 (0.33%) 
Migraine  1  2/304 (0.66%) 
Paraesthesia  1  2/304 (0.66%) 
Sedation  1  2/304 (0.66%) 
Somnolence  1  38/304 (12.50%) 
Tremor  1  3/304 (0.99%) 
Visual field defect  1  1/304 (0.33%) 
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous  1  1/304 (0.33%) 
Pregnancy  1  2/304 (0.66%) 
Psychiatric disorders   
Anger  1  1/304 (0.33%) 
Anxiety  1  2/304 (0.66%) 
Depression  1  14/304 (4.61%) 
Depression suicidal  1  3/304 (0.99%) 
Dissociative disorder  1  1/304 (0.33%) 
Eating disorder  1  1/304 (0.33%) 
Hallucination  1  1/304 (0.33%) 
Impulsive behaviour  1  1/304 (0.33%) 
Initial insomnia  1  1/304 (0.33%) 
Insomnia  1  13/304 (4.28%) 
Insomnia related to another mental condition  1  1/304 (0.33%) 
Intentional self−injury  1  1/304 (0.33%) 
Libido decreased  1  2/304 (0.66%) 
Nervousness  1  1/304 (0.33%) 
Nightmare  1  1/304 (0.33%) 
Restlessness  1  1/304 (0.33%) 
Self injurious behaviour  1  1/304 (0.33%) 
Suicidal ideation  1  12/304 (3.95%) 
Withdrawal syndrome  1  1/304 (0.33%) 
Renal and urinary disorders   
Calculus ureteric  1  1/304 (0.33%) 
Pollakiuria  1  1/304 (0.33%) 
Proteinuria  1  1/304 (0.33%) 
Reproductive system and breast disorders   
Dysmenorrhoea  1  2/304 (0.66%) 
Endometriosis  1  1/304 (0.33%) 
Erectile dysfunction  1  2/304 (0.66%) 
Genital haemorrhage  1  1/304 (0.33%) 
Menstrual disorder  1  1/304 (0.33%) 
Menstruation delayed  1  1/304 (0.33%) 
Menstruation irregular  1  5/304 (1.64%) 
Metrorrhagia  1  2/304 (0.66%) 
Oligomenorrhoea  1  1/304 (0.33%) 
Premenstrual syndrome  1  1/304 (0.33%) 
Sexual dysfunction  1  2/304 (0.66%) 
Vaginal haemorrhage  1  1/304 (0.33%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/304 (0.33%) 
Cough  1  2/304 (0.66%) 
Epistaxis  1  2/304 (0.66%) 
Hiccups  1  1/304 (0.33%) 
Hyperventilation  1  2/304 (0.66%) 
Oropharyngeal pain  1  5/304 (1.64%) 
Rhinitis allergic  1  3/304 (0.99%) 
Rhinorrhoea  1  2/304 (0.66%) 
Suffocation feeling  1  1/304 (0.33%) 
Throat irritation  1  1/304 (0.33%) 
Yawning  1  3/304 (0.99%) 
Skin and subcutaneous tissue disorders   
Alopecia areata  1  1/304 (0.33%) 
Dermatitis allergic  1  1/304 (0.33%) 
Dermatitis contact  1  4/304 (1.32%) 
Dry skin  1  1/304 (0.33%) 
Eczema  1  5/304 (1.64%) 
Haemorrhage subcutaneous  1  1/304 (0.33%) 
Heat rash  1  2/304 (0.66%) 
Hyperhidrosis  1  4/304 (1.32%) 
Hyperkeratosis  1  1/304 (0.33%) 
Night sweats  1  2/304 (0.66%) 
Pruritus  1  1/304 (0.33%) 
Psoriasis  1  1/304 (0.33%) 
Rash  1  3/304 (0.99%) 
Rash generalised  1  1/304 (0.33%) 
Skin odour abnormal  1  1/304 (0.33%) 
Toxic skin eruption  1  1/304 (0.33%) 
Urticaria  1  3/304 (0.99%) 
Urticaria thermal  1  1/304 (0.33%) 
Vitiligo  1  1/304 (0.33%) 
Xeroderma  1  1/304 (0.33%) 
Social circumstances   
Pregnancy of partner  1  1/304 (0.33%) 
Vascular disorders   
Hot flush  1  2/304 (0.66%) 
Hypertension  1  4/304 (1.32%) 
Hypotension  1  1/304 (0.33%) 
Orthostatic hypotension  1  4/304 (1.32%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
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.
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: NCT00831415     History of Changes
Other Study ID Numbers: 3151A1-3350
B2061002
First Submitted: January 27, 2009
First Posted: January 29, 2009
Results First Submitted: December 22, 2011
Results First Posted: January 30, 2012
Last Update Posted: December 7, 2018