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Trial record 5 of 31 for:    alzheimer dijon

Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients

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: NCT00676143
Recruitment Status : Terminated (The study was terminated on August 6, 2012, because 2 large Phase 3 studies showed no clinical benefit. This decision was not based on any new safety concerns.)
First Posted : May 12, 2008
Results First Posted : June 10, 2016
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer Disease
Interventions: Drug: bapineuzumab
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 218 centers across the world. The study was terminated early by the sponsor on 06 August 2012. Enrollment had already been completed at the time of this decision. Participants who were still participating at that time were asked to complete an early withdrawal visit.

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

Reporting Groups
  Description
Placebo Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
Bapineuzumab Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks

Participant Flow:   Overall Study
    Placebo   Bapineuzumab
STARTED   441   658 
Treated   439   654 
COMPLETED   285   398 
NOT COMPLETED   156   260 
Adverse Event                34                60 
Death                4                4 
Lack of Efficacy                0                6 
Lost to Follow-up                0                13 
Physician Decision                5                8 
Protocol Violation                4                8 
Withdrawal by Subject                24                42 
Discontinuation of study by sponsor                65                88 
Failed to return                2                1 
Loss of caregiver                5                3 
Not specified                11                20 
Participant participation unknown                1                4 
Vasogenic edema recurrence                1                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population included all randomized participants who received at least one infusion or portion of an infusion of study drug.

Reporting Groups
  Description
Placebo Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
Bapineuzumab Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Total Total of all reporting groups

Baseline Measures
   Placebo   Bapineuzumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 439   654   1093 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.3  (7.75)   71.0  (7.67)   70.7  (7.71) 
Age, Customized 
[Units: Number of participants]
     
<65 years   97   132   229 
>=65 years   342   522   864 
Gender 
[Units: Number of participants]
     
Female   262   421   683 
Male   177   233   410 


  Outcome Measures

1.  Primary:   Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78   [ Time Frame: Baseline and 78 weeks ]

2.  Primary:   Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78   [ Time Frame: Baseline and 78 weeks ]

3.  Secondary:   Change From Baseline in Brain Amyloid Burden at Week 71   [ Time Frame: Baseline and 71 weeks ]

4.  Secondary:   Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71   [ Time Frame: Baseline and 71 Weeks ]

5.  Secondary:   Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71   [ Time Frame: Baseline and 71 Weeks ]

6.  Secondary:   Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78   [ Time Frame: Week 39 to Week 78 ]

7.  Secondary:   Divergence of Effect on the DAD Total Scores From Week 39 to Week 78   [ Time Frame: Week 39 to Week 78 ]

8.  Secondary:   Time to First Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

9.  Secondary:   Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

10.  Secondary:   Time to First Median Placebo Deterioration on DAD Total Score (EU Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

11.  Secondary:   Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis)   [ Time Frame: Baseline and 78 Weeks ]

12.  Secondary:   Change From Baseline in Dependence Scale Total Score at Week 78   [ Time Frame: Baseline and 78 Weeks ]

13.  Secondary:   Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (EU Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

14.  Secondary:   Percentage of Responders for ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

15.  Secondary:   Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (EU Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

16.  Secondary:   Percentage of Responders for DAD Total Score at Week 78 (US Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

17.  Secondary:   Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78   [ Time Frame: Baseline and 78 Weeks ]


  Serious Adverse Events

Time Frame 4 years
Additional 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Reporting Groups
  Description
Placebo Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
Bapineuzumab Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks

Serious Adverse Events
    Placebo   Bapineuzumab
Total, Serious Adverse Events     
# participants affected / at risk   77/439 (17.54%)   137/654 (20.95%) 
Blood and lymphatic system disorders     
Anaemia * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Bone marrow failure * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Leukocytosis * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Cardiac disorders     
Acute myocardial infarction * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Angina pectoris * 1     
# participants affected / at risk   2/439 (0.46%)   1/654 (0.15%) 
# events   3   1 
Angina unstable * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Atrial fibrillation * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Atrioventricular block complete * 1     
# participants affected / at risk   0/439 (0.00%)   2/654 (0.31%) 
# events   0   2 
Atrioventricular block second degree * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Bradycardia * 1     
# participants affected / at risk   1/439 (0.23%)   1/654 (0.15%) 
# events   1   1 
Cardiac arrest * 1     
# participants affected / at risk   1/439 (0.23%)   1/654 (0.15%) 
# events   1   1 
Cardiovascular insufficiency * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Hypertensive heart disease * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Myocardial infarction * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Myocardial ischaemia * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Sinus bradycardia * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Supraventricular tachycardia * 1     
# participants affected / at risk   1/439 (0.23%)   1/654 (0.15%) 
# events   1   1 
Tachycardia * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Eye disorders     
Cataract * 1     
# participants affected / at risk   0/439 (0.00%)   2/654 (0.31%) 
# events   0   2 
Vitreous haemorrhage * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Gastrointestinal disorders     
Abdominal pain * 1     
# participants affected / at risk   1/439 (0.23%)   1/654 (0.15%) 
# events   1   1 
Abdominal pain upper * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Anal haemorrhage * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Colonic polyp * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Diarrhoea * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Duodenal ulcer perforation * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   3 
Gastric ulcer * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Gastrointestinal ulcer haemorrhage * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Haematemesis * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Ileus * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Inguinal hernia * 1     
# participants affected / at risk   2/439 (0.46%)   0/654 (0.00%) 
# events   2   0 
Inguinal hernia, obstructive * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Intestinal obstruction * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Nausea * 1     
# participants affected / at risk   0/439 (0.00%)   2/654 (0.31%) 
# events   0   2 
Oesophageal ulcer * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Pancreatitis * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Pancreatitis acute * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Vomiting * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
General disorders     
Chest discomfort * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Chest pain * 1     
# participants affected / at risk   1/439 (0.23%)   2/654 (0.31%) 
# events   1   2 
Device occlusion * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Fibrosis * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
General physical health deterioration * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   2 
Malaise * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Non-cardiac chest pain * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Pain * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Pyrexia * 1     
# participants affected / at risk   0/439 (0.00%)   2/654 (0.31%) 
# events   0   2 
Hepatobiliary disorders     
Bile duct stone * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Cholangitis * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Cholecystitis * 1     
# participants affected / at risk   1/439 (0.23%)   1/654 (0.15%) 
# events   1   1 
Cholelithiasis * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Gallbladder disorder * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Hepatic function abnormal * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Jaundice * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Immune system disorders     
Hypersensitivity * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Infections and infestations     
Abdominal abscess * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Abscess * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Appendicitis * 1     
# participants affected / at risk   0/439 (0.00%)   2/654 (0.31%) 
# events   0   2 
Bacterial Sepsis * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Bronchitis * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Cellulitis * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Gastroenteritis * 1     
# participants affected / at risk   1/439 (0.23%)   1/654 (0.15%) 
# events   1   1 
Herpes zoster * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Infected skin ulcer * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Kidney infection * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Lower respiratory tract infection * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Meningitis cryptococcal * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Osteomyelitis * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Paronychia * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Pneumonia * 1     
# participants affected / at risk   3/439 (0.68%)   6/654 (0.92%) 
# events   3   6 
Pseudomembranous colitis * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Pyelonephritis * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Sepsis * 1     
# participants affected / at risk   3/439 (0.68%)   1/654 (0.15%) 
# events   4   1 
Toxic shock syndrome * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Urinary tract infection * 1     
# participants affected / at risk   2/439 (0.46%)   2/654 (0.31%) 
# events   2   2 
Urosepsis * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Vaginitis bacterial * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Viral upper respiratory tract infection * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Injury, poisoning and procedural complications     
Accidental overdose * 1     
# participants affected / at risk   1/439 (0.23%)   2/654 (0.31%) 
# events   1   3 
Ankle fracture * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Contusion * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Drug administration error * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Excoriation * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Eye injury * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Fall * 1     
# participants affected / at risk   1/439 (0.23%)   2/654 (0.31%) 
# events   2   2 
Femoral neck fracture * 1     
# participants affected / at risk   0/439 (0.00%)   2/654 (0.31%) 
# events   0   5 
Femur fracture * 1     
# participants affected / at risk   1/439 (0.23%)   3/654 (0.46%) 
# events   1   3 
Head injury * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Hip fracture * 1     
# participants affected / at risk   2/439 (0.46%)   1/654 (0.15%) 
# events   5   1 
Humerus fracture * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   3 
Post lumbar puncture syndrome * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Pubis fracture * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Radius fracture * 1     
# participants affected / at risk   2/439 (0.46%)   0/654 (0.00%) 
# events   3   0 
Rib fracture * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   3   0 
Spinal compression fracture * 1     
# participants affected / at risk   2/439 (0.46%)   1/654 (0.15%) 
# events   7   1 
Stab wound * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Subdural haematoma * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Upper limb fracture * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   2   0 
Wrist fracture * 1     
# participants affected / at risk   2/439 (0.46%)   0/654 (0.00%) 
# events   5   0 
Investigations     
Blood pressure increased * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   2   0 
Fibrin D dimer increased * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Heart rate increased * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Streptococcus test positive * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Metabolism and nutrition disorders     
Dehydration * 1     
# participants affected / at risk   2/439 (0.46%)   3/654 (0.46%) 
# events   2   4 
Hypoglycaemia * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Hypokalaemia * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Hyponatraemia * 1     
# participants affected / at risk   0/439 (0.00%)   2/654 (0.31%) 
# events   0   2 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Arthritis * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Back pain * 1     
# participants affected / at risk   1/439 (0.23%)   2/654 (0.31%) 
# events   1   2 
Intervertebral disc protrusion * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Lumbar spinal stenosis * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Osteoarthritis * 1     
# participants affected / at risk   1/439 (0.23%)   1/654 (0.15%) 
# events   1   1 
Polymyalgia rheumatica * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Rhabdomyolysis * 1     
# participants affected / at risk   2/439 (0.46%)   2/654 (0.31%) 
# events   2   2 
Spinal column stenosis * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Basal cell carcinoma * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Bladder cancer * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Breast cancer * 1     
# participants affected / at risk   2/439 (0.46%)   2/654 (0.31%) 
# events   2   2 
Breast neoplasm * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Hepatic neoplasm * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Leiomyosarcoma * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Lentigo maligna * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Metastatic neoplasm * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Neoplasm prostate * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Oesophageal carcinoma * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Prostate cancer * 1     
# participants affected / at risk   4/439 (0.91%)   1/654 (0.15%) 
# events   5   1 
Squamous cell carcinoma * 1     
# participants affected / at risk   3/439 (0.68%)   0/654 (0.00%) 
# events   3   0 
Nervous system disorders     
Amyotrophic lateral sclerosis * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   5 
Aphasia * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Brain stem ischaemia * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Cerebral haemorrhage * 1     
# participants affected / at risk   1/439 (0.23%)   3/654 (0.46%) 
# events   1   3 
Cerebral haemosiderin deposition * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Cerebral infarction * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Cerebral ischaemia * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Cerebral microhaemorrhage * 1     
# participants affected / at risk   0/439 (0.00%)   4/654 (0.61%) 
# events   0   4 
Cerebrovascular accident * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   2   0 
Convulsion * 1     
# participants affected / at risk   0/439 (0.00%)   3/654 (0.46%) 
# events   0   3 
Dizziness * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   2 
Epilepsy * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Grand mal convulsion * 1     
# participants affected / at risk   1/439 (0.23%)   2/654 (0.31%) 
# events   1   2 
Haemorrhagic stroke * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Hydrocephalus * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Ischaemic stroke * 1     
# participants affected / at risk   0/439 (0.00%)   2/654 (0.31%) 
# events   0   3 
Lacunar infarction * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   4   0 
Lethargy * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Loss of consciousness * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Mental impairment * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Paraesthesia * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Presyncope * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Syncope * 1     
# participants affected / at risk   2/439 (0.46%)   4/654 (0.61%) 
# events   2   4 
Transient ischaemic attack * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Vasogenic cerebral oedema * 1     
# participants affected / at risk   4/439 (0.91%)   40/654 (6.12%) 
# events   5   61 
Visual field defect * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Agitation * 1     
# participants affected / at risk   1/439 (0.23%)   2/654 (0.31%) 
# events   3   2 
Psychiatric disorders     
Abnormal behaviour * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Aggression * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Completed suicide * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Confusional state * 1     
# participants affected / at risk   2/439 (0.46%)   3/654 (0.46%) 
# events   2   3 
Delirium * 1     
# participants affected / at risk   1/439 (0.23%)   2/654 (0.31%) 
# events   2   2 
Depression * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Hallucination * 1     
# participants affected / at risk   1/439 (0.23%)   1/654 (0.15%) 
# events   1   1 
Mental status changes * 1     
# participants affected / at risk   2/439 (0.46%)   3/654 (0.46%) 
# events   2   3 
Restlessness * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Suicide attempt * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Renal and urinary disorders     
Acute prerenal failure * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Haematuria * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Pollakiuria * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Renal failure acute * 1     
# participants affected / at risk   1/439 (0.23%)   2/654 (0.31%) 
# events   1   2 
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Breast mass * 1     
# participants affected / at risk   1/439 (0.23%)   1/654 (0.15%) 
# events   1   1 
Rectocele * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Paranasal cyst * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Pneumonia aspiration * 1     
# participants affected / at risk   1/439 (0.23%)   1/654 (0.15%) 
# events   2   1 
Pulmonary embolism * 1     
# participants affected / at risk   2/439 (0.46%)   3/654 (0.46%) 
# events   2   3 
Pulmonary oedema * 1     
# participants affected / at risk   1/439 (0.23%)   3/654 (0.46%) 
# events   1   3 
Respiratory failure * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Social circumstances     
Social problem * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Surgical and medical procedures     
Thyroidectomy * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Vascular disorders     
Arteriosclerosis * 1     
# participants affected / at risk   1/439 (0.23%)   0/654 (0.00%) 
# events   1   0 
Deep vein thrombosis * 1     
# participants affected / at risk   1/439 (0.23%)   5/654 (0.76%) 
# events   1   5 
Ischaemia * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
Peripheral artery stenosis * 1     
# participants affected / at risk   0/439 (0.00%)   1/654 (0.15%) 
# events   0   1 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA v15.0




  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00676143     History of Changes
Obsolete Identifiers: NCT00909675
Other Study ID Numbers: 3133K1-3001
B2521002 ( Other Identifier: Alias Study Number )
2007-005995-14 ( EudraCT Number )
First Submitted: May 2, 2008
First Posted: May 12, 2008
Results First Submitted: October 14, 2013
Results First Posted: June 10, 2016
Last Update Posted: June 10, 2016