Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab
Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00916617
Collaborator
JANSSEN Alzheimer Immunotherapy Research & Development, LLC (Industry)
62
16
1
39
3.9
0.1
Study Details
Study Description
Brief Summary
This study will evaluate the safety and tolerability of bapineuzumab when administered by subcutaneous injection. The study is open only to subjects who participated in the preceding double-blind study (3133L1-2203 US). Subjects will receive weekly injections of bapineuzumab for 3 years (156 doses). One dosage level will be included: 5 mg/week. All subjects will receive active treatment (bapineuzumab) and no subjects will receive placebo.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
62 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open Label, Multiple Dose, Parallel Group Investigation Of The Long-term Safety, Tolerability, Reactogenicity, Pharmacokinetics And Pharmacodynamics Of Aab-001 Administered Subcutaneously In Subjects With Mild To Moderate Alzheimer's Disease
Study Start Date
:
Jun 1, 2009
Actual Primary Completion Date
:
Sep 1, 2012
Actual Study Completion Date
:
Sep 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 5 mg/week |
Drug: bapineuzumab
5 mg/week subcutaneous bapineuzumab
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings [Week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, Any visit]
A brain Magnetic Resonance Imaging (MRI) was obtained from all participants at Week 13 and quarterly thereafter. Participants were to meet the following criteria: screening brain MRI scan is consistent with the diagnosis of Alzheimer's Disease. Screening diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria. Clinically significant MRIs were identified by the investigator. The number of participants with clinically significant MRIs are tabulated by visit and treatment group.
Secondary Outcome Measures
- Pharmacokinetic Parameters Including Maximal Serum Drug Concentration, Time to Maximal Serum Drug Concentration, and Terminal Half-life of Elimination [36 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosis of probable Alzheimer disease
-
Completed preceding double-blind study (3133L1-2203 US)
-
MMSE score > 9.
Exclusion Criteria:
-
Significant brain MRI abnormalities
-
Clinically important psychiatric symptoms
-
History of stroke
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Banner Alzheimer's Institute | Phoenix | Arizona | United States | 85006 |
| 2 | Pharmacology Research Institute | Encino | California | United States | 91316 |
| 3 | Brain Matters Research | Delray Beach | Florida | United States | 33445 |
| 4 | MD Clinical | Hallandale Beach | Florida | United States | 33009 |
| 5 | Palm Beach Neurology - Premiere Research Institute | West Palm Beach | Florida | United States | 33407 |
| 6 | Neurostudies.net | Decatur | Georgia | United States | 30033 |
| 7 | Dekalb Neurology Associates, LLC | Lawrenceville | Georgia | United States | 30045 |
| 8 | NeuroStudies.net | Lawrenceville | Georgia | United States | 30046 |
| 9 | Clinical Research Institute | Wichita | Kansas | United States | 67207 |
| 10 | Monroe Community Hospital | Rochester | New York | United States | 14620 |
| 11 | Rhode Island Mood and Memory Research Institute | East Providence | Rhode Island | United States | 02914 |
| 12 | Butler Hospital | Providence | Rhode Island | United States | 02906 |
| 13 | Texas Neurology, P.A. | Dallas | Texas | United States | 75214 |
| 14 | The Memory Clinic | Bennington | Vermont | United States | 05201 |
| 15 | University of Wisconsin, Department of Surgery | Madison | Wisconsin | United States | 53705 |
| 16 | University of Wisconsin | Madison | Wisconsin | United States | 53792 |
Sponsors and Collaborators
- Pfizer
- JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00916617
Other Study ID Numbers:
- 3133L1-2204
- B2521009
First Posted:
Jun 9, 2009
Last Update Posted:
Jun 1, 2017
Last Verified:
Apr 1, 2017
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants who completed the parent Study NCT00663026 and met the study criteria were enrolled and randomized into each of 3 dose cohorts to receive bapineuzumab or placebo. The study was terminated early on 06 August 2012 because 2 Phase 3 studies showed no clinical benefit. The decision was not based on any new safety concerns. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Bapineuzumab (5 mg + 5 mg) | Bapineuzumab (10 mg + 10 mg) | Placebo + Bapineuzumab 5mg | Placebo + Bapineuzumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study. | Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study. | Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study. | Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study. |
| Period Title: Overall Study | ||||
| STARTED | 24 | 21 | 10 | 7 |
| COMPLETED | 1 | 0 | 0 | 0 |
| NOT COMPLETED | 23 | 21 | 10 | 7 |
Baseline Characteristics
| Arm/Group Title | Bapineuzumab (5 mg + 5 mg) | Bapineuzumab (10 mg + 10 mg) | Placebo + Bapineuzumab 5mg | Placebo + Bapineuzumab 10 mg | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study. | Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study. | Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study. | Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study. | Total of all reporting groups |
| Overall Participants | 23 | 21 | 10 | 7 | 61 |
| Age (Years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Years] |
72.2
(8.92)
|
74.0
(9.34)
|
80.4
(5.54)
|
70.3
(10.13)
|
73.9
(9.10)
|
| Age, Customized (Number) [Number] | |||||
| Less than (<) 65 years |
4
17.4%
|
3
14.3%
|
0
0%
|
2
28.6%
|
9
14.8%
|
| Greater than or equal to (>=) 65 years |
19
82.6%
|
18
85.7%
|
10
100%
|
5
71.4%
|
52
85.2%
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
14
60.9%
|
8
38.1%
|
6
60%
|
2
28.6%
|
30
49.2%
|
| Male |
9
39.1%
|
13
61.9%
|
4
40%
|
5
71.4%
|
31
50.8%
|
Outcome Measures
| Title | Number of Participants Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings |
|---|---|
| Description | A brain Magnetic Resonance Imaging (MRI) was obtained from all participants at Week 13 and quarterly thereafter. Participants were to meet the following criteria: screening brain MRI scan is consistent with the diagnosis of Alzheimer's Disease. Screening diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria. Clinically significant MRIs were identified by the investigator. The number of participants with clinically significant MRIs are tabulated by visit and treatment group. |
| Time Frame | Week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, Any visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety population included all participants who received at least 1 dose of study medication in Study NCT00916617. |
| Arm/Group Title | Bapineuzumab (5 mg + 5 mg) | Bapineuzumab (10 mg + 10 mg) | Placebo + Bapineuzumab 5mg | Placebo + Bapineuzumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study. | Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study. | Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study. | Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study. |
| Measure Participants | 23 | 21 | 10 | 7 |
| Week 13 |
0
0%
|
2
9.5%
|
1
10%
|
0
0%
|
| Week 26 |
1
4.3%
|
0
0%
|
1
10%
|
0
0%
|
| Week 39 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 52 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 65 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 78 |
0
0%
|
1
4.8%
|
0
0%
|
0
0%
|
| Week 91 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 104 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 117 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 130 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 143 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 156 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any visit |
1
4.3%
|
3
14.3%
|
1
10%
|
0
0%
|
| Title | Pharmacokinetic Parameters Including Maximal Serum Drug Concentration, Time to Maximal Serum Drug Concentration, and Terminal Half-life of Elimination |
|---|---|
| Description | |
| Time Frame | 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Because this study was terminated early, the planned pharmacokinetic analyses were not performed. |
| Arm/Group Title | Bapineuzumab (5 mg + 5 mg) | Bapineuzumab (10 mg + 10 mg) | Placebo + Bapineuzumab 5mg | Placebo + Bapineuzumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study. | Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study. | Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study. | Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study. |
| Measure Participants | 0 | 0 | 0 | 0 |
Adverse Events
| Time Frame | 3 years | |||||||
|---|---|---|---|---|---|---|---|---|
| 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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. | |||||||
| Arm/Group Title | Bapineuzumab (5 mg + 5 mg) | Bapineuzumab (10 mg + 10 mg) | Placebo + Bapineuzumab 5mg | Placebo + Bapineuzumab 10 mg | ||||
| Arm/Group Description | Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study. | Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study. | Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study. | Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study. | ||||
All Cause Mortality |
||||||||
| Bapineuzumab (5 mg + 5 mg) | Bapineuzumab (10 mg + 10 mg) | Placebo + Bapineuzumab 5mg | Placebo + Bapineuzumab 10 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Bapineuzumab (5 mg + 5 mg) | Bapineuzumab (10 mg + 10 mg) | Placebo + Bapineuzumab 5mg | Placebo + Bapineuzumab 10 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/23 (17.4%) | 5/21 (23.8%) | 7/10 (70%) | 2/7 (28.6%) | ||||
| Cardiac disorders | ||||||||
| Angina pectoris | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Atrial flutter | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Myocardial infarction | 1/23 (4.3%) | 1 | 0/21 (0%) | 0 | 0/10 (0%) | 0 | 0/7 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 1/23 (4.3%) | 1 | 0/21 (0%) | 0 | 0/10 (0%) | 0 | 0/7 (0%) | 0 |
| Diarrhoea | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Intestinal obstruction | 0/23 (0%) | 0 | 1/21 (4.8%) | 1 | 0/10 (0%) | 0 | 0/7 (0%) | 0 |
| Melaena | 1/23 (4.3%) | 1 | 0/21 (0%) | 0 | 0/10 (0%) | 0 | 0/7 (0%) | 0 |
| General disorders | ||||||||
| Asthenia | 1/23 (4.3%) | 1 | 0/21 (0%) | 0 | 0/10 (0%) | 0 | 0/7 (0%) | 0 |
| Chest pain | 1/23 (4.3%) | 1 | 0/21 (0%) | 0 | 0/10 (0%) | 0 | 0/7 (0%) | 0 |
| Infections and infestations | ||||||||
| Bronchitis | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Gastroenteritis | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 1/7 (14.3%) | 1 |
| Lobar pneumonia | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Pneumonia | 0/23 (0%) | 0 | 1/21 (4.8%) | 2 | 0/10 (0%) | 0 | 0/7 (0%) | 0 |
| Urinary tract infection | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Ankle fracture | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Subdural haematoma | 0/23 (0%) | 0 | 1/21 (4.8%) | 1 | 0/10 (0%) | 0 | 0/7 (0%) | 0 |
| Thoracic vertebral fracture | 0/23 (0%) | 0 | 1/21 (4.8%) | 1 | 0/10 (0%) | 0 | 0/7 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Dehydration | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 2/10 (20%) | 2 | 0/7 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Spinal column stenosis | 0/23 (0%) | 0 | 1/21 (4.8%) | 1 | 0/10 (0%) | 0 | 0/7 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Bladder cancer | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Prostate cancer | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 0/10 (0%) | 0 | 1/7 (14.3%) | 1 |
| Nervous system disorders | ||||||||
| Syncope | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Psychiatric disorders | ||||||||
| Depressive symptom | 0/23 (0%) | 0 | 1/21 (4.8%) | 1 | 0/10 (0%) | 0 | 0/7 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||
| Pelvic pain | 1/23 (4.3%) | 1 | 0/21 (0%) | 0 | 0/10 (0%) | 0 | 0/7 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Haemoptysis | 0/23 (0%) | 0 | 1/21 (4.8%) | 1 | 0/10 (0%) | 0 | 0/7 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| Bapineuzumab (5 mg + 5 mg) | Bapineuzumab (10 mg + 10 mg) | Placebo + Bapineuzumab 5mg | Placebo + Bapineuzumab 10 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 19/23 (82.6%) | 16/21 (76.2%) | 10/10 (100%) | 6/7 (85.7%) | ||||
| Cardiac disorders | ||||||||
| Atrial fibrillation | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Constipation | 1/23 (4.3%) | 1 | 0/21 (0%) | 0 | 3/10 (30%) | 3 | 0/7 (0%) | 0 |
| Diarrhoea | 1/23 (4.3%) | 2 | 1/21 (4.8%) | 1 | 1/10 (10%) | 2 | 0/7 (0%) | 0 |
| Dysphagia | 0/23 (0%) | 0 | 1/21 (4.8%) | 1 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Gastrooesophageal reflux disease | 2/23 (8.7%) | 2 | 0/21 (0%) | 0 | 3/10 (30%) | 3 | 0/7 (0%) | 0 |
| Hiatus hernia | 2/23 (8.7%) | 2 | 0/21 (0%) | 0 | 3/10 (30%) | 3 | 0/7 (0%) | 0 |
| Nausea | 1/23 (4.3%) | 1 | 2/21 (9.5%) | 2 | 0/10 (0%) | 0 | 1/7 (14.3%) | 1 |
| Toothache | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Vomiting | 0/23 (0%) | 0 | 2/21 (9.5%) | 3 | 2/10 (20%) | 2 | 1/7 (14.3%) | 1 |
| General disorders | ||||||||
| Asthenia | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Gait disturbance | 2/23 (8.7%) | 2 | 3/21 (14.3%) | 4 | 1/10 (10%) | 2 | 0/7 (0%) | 0 |
| Injection site bruising | 1/23 (4.3%) | 1 | 1/21 (4.8%) | 2 | 0/10 (0%) | 0 | 1/7 (14.3%) | 1 |
| Injection site reaction | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 12 | 1/7 (14.3%) | 3 |
| Oedema | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Oedema peripheral | 0/23 (0%) | 0 | 1/21 (4.8%) | 1 | 2/10 (20%) | 2 | 0/7 (0%) | 0 |
| Pyrexia | 3/23 (13%) | 3 | 0/21 (0%) | 0 | 0/10 (0%) | 0 | 0/7 (0%) | 0 |
| Infections and infestations | ||||||||
| Bacterial infection | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Bronchitis | 2/23 (8.7%) | 2 | 1/21 (4.8%) | 2 | 0/10 (0%) | 0 | 0/7 (0%) | 0 |
| Fungal skin infection | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Gastroenteritis viral | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Mastoiditis | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Nasopharyngitis | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 2 | 1/7 (14.3%) | 1 |
| Pneumonia | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Sinusitis | 0/23 (0%) | 0 | 3/21 (14.3%) | 3 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Tooth abscess | 0/23 (0%) | 0 | 2/21 (9.5%) | 2 | 2/10 (20%) | 2 | 0/7 (0%) | 0 |
| Tooth infection | 0/23 (0%) | 0 | 1/21 (4.8%) | 1 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Upper respiratory tract infection | 6/23 (26.1%) | 9 | 4/21 (19%) | 6 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Urinary tract infection | 2/23 (8.7%) | 2 | 1/21 (4.8%) | 1 | 2/10 (20%) | 5 | 1/7 (14.3%) | 4 |
| Injury, poisoning and procedural complications | ||||||||
| Animal bite | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Contusion | 2/23 (8.7%) | 5 | 1/21 (4.8%) | 1 | 0/10 (0%) | 0 | 1/7 (14.3%) | 1 |
| Fall | 1/23 (4.3%) | 1 | 4/21 (19%) | 8 | 2/10 (20%) | 3 | 2/7 (28.6%) | 3 |
| Joint injury | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Laceration | 2/23 (8.7%) | 2 | 1/21 (4.8%) | 1 | 1/10 (10%) | 1 | 1/7 (14.3%) | 1 |
| Ligament sprain | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 0/10 (0%) | 0 | 1/7 (14.3%) | 1 |
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 0/23 (0%) | 0 | 2/21 (9.5%) | 3 | 0/10 (0%) | 0 | 0/7 (0%) | 0 |
| Dehydration | 0/23 (0%) | 0 | 1/21 (4.8%) | 1 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Diabetes mellitus | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Gout | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 0/10 (0%) | 0 | 1/7 (14.3%) | 2 |
| Hyperkalaemia | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 0/10 (0%) | 0 | 1/7 (14.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 4/23 (17.4%) | 6 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 1/7 (14.3%) | 1 |
| Back pain | 2/23 (8.7%) | 2 | 4/21 (19%) | 6 | 2/10 (20%) | 3 | 2/7 (28.6%) | 2 |
| Muscular weakness | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Musculoskeletal pain | 0/23 (0%) | 0 | 1/21 (4.8%) | 1 | 0/10 (0%) | 0 | 1/7 (14.3%) | 1 |
| Osteoarthritis | 1/23 (4.3%) | 1 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Nervous system disorders | ||||||||
| Action tremor | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Amnesia | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Aphasia | 1/23 (4.3%) | 1 | 1/21 (4.8%) | 1 | 0/10 (0%) | 0 | 1/7 (14.3%) | 2 |
| Apraxia | 0/23 (0%) | 0 | 1/21 (4.8%) | 2 | 0/10 (0%) | 0 | 1/7 (14.3%) | 1 |
| Bradykinesia | 0/23 (0%) | 0 | 1/21 (4.8%) | 1 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Cerebral microhaemorrhage | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Cogwheel rigidity | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Convulsion | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Coordination abnormal | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 1/7 (14.3%) | 2 |
| Dementia | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 0/10 (0%) | 0 | 1/7 (14.3%) | 1 |
| Dementia Alzheimer's type | 2/23 (8.7%) | 3 | 1/21 (4.8%) | 1 | 1/10 (10%) | 1 | 1/7 (14.3%) | 1 |
| Dementia with Lewy bodies | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Dizziness | 1/23 (4.3%) | 1 | 0/21 (0%) | 0 | 2/10 (20%) | 2 | 1/7 (14.3%) | 1 |
| Dysgeusia | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 0/10 (0%) | 0 | 1/7 (14.3%) | 1 |
| Dystonia | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Hyporeflexia | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 2 | 0/7 (0%) | 0 |
| Masked facies | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Motor dysfunction | 1/23 (4.3%) | 1 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Movement disorder | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 1/7 (14.3%) | 1 |
| Paraesthesia | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 2 | 0/7 (0%) | 0 |
| Sleep phase rhythm disturbance | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Somnolence | 2/23 (8.7%) | 2 | 0/21 (0%) | 0 | 2/10 (20%) | 2 | 0/7 (0%) | 0 |
| Speech disorder | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 2/10 (20%) | 3 | 0/7 (0%) | 0 |
| Vasogenic cerebral oedema | 3/23 (13%) | 4 | 0/21 (0%) | 0 | 2/10 (20%) | 3 | 1/7 (14.3%) | 1 |
| Psychiatric disorders | ||||||||
| Agitation | 2/23 (8.7%) | 2 | 1/21 (4.8%) | 2 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Anxiety | 0/23 (0%) | 0 | 3/21 (14.3%) | 3 | 0/10 (0%) | 0 | 1/7 (14.3%) | 1 |
| Confusional state | 2/23 (8.7%) | 2 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Depression | 0/23 (0%) | 0 | 3/21 (14.3%) | 4 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Hallucination | 2/23 (8.7%) | 2 | 1/21 (4.8%) | 1 | 0/10 (0%) | 0 | 0/7 (0%) | 0 |
| Hallucination, visual | 0/23 (0%) | 0 | 1/21 (4.8%) | 1 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Insomnia | 2/23 (8.7%) | 3 | 2/21 (9.5%) | 2 | 0/10 (0%) | 0 | 0/7 (0%) | 0 |
| Nightmare | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Paranoia | 0/23 (0%) | 0 | 1/21 (4.8%) | 2 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Haematuria | 0/23 (0%) | 0 | 1/21 (4.8%) | 1 | 1/10 (10%) | 1 | 1/7 (14.3%) | 1 |
| Pollakiuria | 2/23 (8.7%) | 2 | 0/21 (0%) | 0 | 0/10 (0%) | 0 | 0/7 (0%) | 0 |
| Urinary incontinence | 1/23 (4.3%) | 1 | 0/21 (0%) | 0 | 0/10 (0%) | 0 | 1/7 (14.3%) | 1 |
| Reproductive system and breast disorders | ||||||||
| Cough | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 1/7 (14.3%) | 1 |
| Dysphonia | 0/23 (0%) | 0 | 1/21 (4.8%) | 1 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Dyspnoea | 0/23 (0%) | 0 | 1/21 (4.8%) | 1 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Pulmonary mass | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Rhinorrhoea | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||
| Rash | 2/23 (8.7%) | 2 | 0/21 (0%) | 0 | 1/10 (10%) | 2 | 2/7 (28.6%) | 2 |
| Skin lesion | 3/23 (13%) | 3 | 1/21 (4.8%) | 1 | 0/10 (0%) | 0 | 0/7 (0%) | 0 |
| Vascular disorders | ||||||||
| Haemorrhage | 0/23 (0%) | 0 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 1/7 (14.3%) | 1 |
| Hypotension | 1/23 (4.3%) | 1 | 0/21 (0%) | 0 | 1/10 (10%) | 1 | 0/7 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00916617
Other Study ID Numbers:
- 3133L1-2204
- B2521009
First Posted:
Jun 9, 2009
Last Update Posted:
Jun 1, 2017
Last Verified:
Apr 1, 2017