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Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00479557
First received: May 24, 2007
Last updated: November 30, 2015
Last verified: November 2015
History of Changes
Results First Received: May 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer Disease
Interventions: Biological: ACC-001 + QS-21
Biological: ACC-001
Biological: QS-21
Drug: Placebo: Phosphate buffered saline

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Planned duration was approximately 110 weeks (including 6 week screening period, 52 weeks of dosing, and 52 weeks of follow-up). Participants who completed the 3134K1-200-EU (B2571004) study through Week 78 had the option to exit after this time point, for continued treatment and follow-up under extension protocol 3134K1-2203-EU (B2571007).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Basic Results disclose pooled data from studies NCT00479557 and NCT00498602.

Reporting Groups
  Description
ACC 3 µg+QS-21 Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
ACC 10 µg+QS-21 Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
ACC 30 µg+QS-21 Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
ACC 10 µg Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
ACC 30 µg Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
QS-21 Alone Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Phosphate Buffered Saline Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.

Participant Flow:   Overall Study
    ACC 3 µg+QS-21   ACC 10 µg+QS-21   ACC 30 µg+QS-21   ACC 10 µg   ACC 30 µg   QS-21 Alone   Phosphate Buffered Saline
STARTED   36   61   40   35   12   44   17 
Treated   36   60 [1]   40   35   12   44   17 
COMPLETED   26   51   32   30   8   31   15 
NOT COMPLETED   10   10   8   5   4   13   2 
Death                0                0                0                0                0                1                0 
Lack of Efficacy                1                0                0                0                0                0                0 
Lost to Follow-up                0                2                0                2                0                0                0 
Adverse Event (AE) related to Study Drug                1                0                3                2                0                1                0 
AE not related to Study Drug                1                3                0                0                2                2                1 
Caregiver Request                2                2                2                0                1                2                0 
Investigator Request                0                0                1                0                0                0                0 
Subject Request                3                0                1                1                1                4                1 
Not specified                2                3                1                0                0                3                0 
[1] One participant discontinued due to an AE, with an outcome of death.



  Baseline Characteristics
  Hide 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.
245 participants were randomized in both studies (86 participants in 3134K1-200-EU [B2571004] and 159 participants in 3134K1-2201-US [B2571005]) and included in the analysis below. One participant of the randomized participants did not receive treatment.

Reporting Groups
  Description
ACC 3 µg+QS-21 Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
ACC 10 µg+QS-21 Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
ACC 30 µg+QS-21 Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
ACC 10 µg Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
ACC 30 µg Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
QS-21 Alone Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Phosphate Buffered Saline Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Total Total of all reporting groups

Baseline Measures
   ACC 3 µg+QS-21   ACC 10 µg+QS-21   ACC 30 µg+QS-21   ACC 10 µg   ACC 30 µg   QS-21 Alone   Phosphate Buffered Saline   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 36   61   40   35   12   44   17   245 
Age 
[Units: Year]
Mean (Standard Deviation) 		 65.7  (7.75)   69.3  (9.57)   69.0  (9.27)   71.9  (8.96)   70.9  (9.59)   68.8  (8.07)   69.4  (7.82)   69.1  (8.87) 
Gender 
[Units: Number of participants]
 		               
Female   16   29   22   19   8   31   14   139 
Male   20   32   18   16   4   13   3   106 
Race/Ethnicity, Customized 
[Units: Number of participants]
 		               
Asian   0   0   0   0   1   0   0   1 
Black or African American   1   0   1   0   0   1   0   3 
Other   2   1   1   1   0   0   0   5 
White   33   60   38   34   11   43   17   236 
Mini-Mental State Examination (MMSE) Score [1] 
[Units: Score]
Mean (Standard Deviation) 		 21.4  (2.96)   21.4  (3.38)   21.0  (2.92)   21.6  (3.16)   21.8  (3.60)   21.7  (3.11)   21.2  (3.17)   21.4  (3.13) 
[1] The MMSE was used to systematically and thoroughly assess mental status of participants. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The total score ranges from 0 to 30. A score of 23 or lower is indicative of cognitive impairment.
MMSE Stratum [1] 
[Units: Number of participants]
 		               
High (21 - 26)   26   40   24   23   8   29   11   161 
Low (16 - 20)   10   21   16   12   4   15   6   84 
[1] The MMSE was used to systematically and thoroughly assess mental status of participants. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The total score ranges from 0 to 30. A score of 23 or lower is indicative of cognitive impairment.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)   [ Time Frame: approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose. ]
  Show Outcome Measure 1

2.  Secondary:   Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104   [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 ]
  Show Outcome Measure 2

3.  Secondary:   GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104   [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)   [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 ]
  Show Outcome Measure 4


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame Approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.
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.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
ACC 3 µg+QS-21 Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
ACC 10 µg+QS-21 Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
ACC 30 µg+QS-21 Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
ACC 10 µg Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
ACC 30 µg Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
QS-21 Alone Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
Phosphate Buffered Saline Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.

Other Adverse Events
    ACC 3 µg+QS-21   ACC 10 µg+QS-21   ACC 30 µg+QS-21   ACC 10 µg   ACC 30 µg   QS-21 Alone   Phosphate Buffered Saline
Total, Other (not including serious) Adverse Events               
# participants affected / at risk   34/36 (94.44%)   48/60 (80.00%)   35/40 (87.50%)   28/35 (80.00%)   10/12 (83.33%)   40/44 (90.91%)   17/17 (100.00%) 
Blood and lymphatic system disorders               
Anaemia * 1               
# participants affected / at risk   1/36 (2.78%)   1/60 (1.67%)   1/40 (2.50%)   1/35 (2.86%)   0/12 (0.00%)   2/44 (4.55%)   1/17 (5.88%) 
Iron deficiency anaemia * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Eye disorders               
Cataract * 1               
# participants affected / at risk   0/36 (0.00%)   3/60 (5.00%)   1/40 (2.50%)   1/35 (2.86%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Eye movement disorder * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Gastrointestinal disorders               
Diarrhoea * 1               
# participants affected / at risk   10/36 (27.78%)   6/60 (10.00%)   4/40 (10.00%)   4/35 (11.43%)   2/12 (16.67%)   3/44 (6.82%)   1/17 (5.88%) 
Nausea * 1               
# participants affected / at risk   5/36 (13.89%)   9/60 (15.00%)   1/40 (2.50%)   2/35 (5.71%)   0/12 (0.00%)   5/44 (11.36%)   1/17 (5.88%) 
Vomiting * 1               
# participants affected / at risk   5/36 (13.89%)   4/60 (6.67%)   1/40 (2.50%)   0/35 (0.00%)   2/12 (16.67%)   5/44 (11.36%)   0/17 (0.00%) 
Abdominal pain * 1               
# participants affected / at risk   0/36 (0.00%)   4/60 (6.67%)   0/40 (0.00%)   2/35 (5.71%)   1/12 (8.33%)   2/44 (4.55%)   0/17 (0.00%) 
Constipation * 1               
# participants affected / at risk   0/36 (0.00%)   2/60 (3.33%)   1/40 (2.50%)   0/35 (0.00%)   2/12 (16.67%)   1/44 (2.27%)   0/17 (0.00%) 
Gastrooesophageal reflux disease * 1               
# participants affected / at risk   0/36 (0.00%)   1/60 (1.67%)   2/40 (5.00%)   0/35 (0.00%)   2/12 (16.67%)   0/44 (0.00%)   0/17 (0.00%) 
Haemorrhoids * 1               
# participants affected / at risk   1/36 (2.78%)   1/60 (1.67%)   1/40 (2.50%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Functional gastrointestinal disorder * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
General disorders               
Injection site pain * 1               
# participants affected / at risk   7/36 (19.44%)   17/60 (28.33%)   9/40 (22.50%)   4/35 (11.43%)   1/12 (8.33%)   6/44 (13.64%)   0/17 (0.00%) 
Fatigue * 1               
# participants affected / at risk   5/36 (13.89%)   7/60 (11.67%)   4/40 (10.00%)   1/35 (2.86%)   0/12 (0.00%)   5/44 (11.36%)   1/17 (5.88%) 
Injection site erythema * 1               
# participants affected / at risk   7/36 (19.44%)   9/60 (15.00%)   6/40 (15.00%)   0/35 (0.00%)   0/12 (0.00%)   1/44 (2.27%)   0/17 (0.00%) 
Injection site swelling * 1               
# participants affected / at risk   2/36 (5.56%)   6/60 (10.00%)   7/40 (17.50%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Asthenia * 1               
# participants affected / at risk   1/36 (2.78%)   2/60 (3.33%)   1/40 (2.50%)   3/35 (8.57%)   2/12 (16.67%)   1/44 (2.27%)   0/17 (0.00%) 
Oedema peripheral * 1               
# participants affected / at risk   2/36 (5.56%)   2/60 (3.33%)   2/40 (5.00%)   1/35 (2.86%)   1/12 (8.33%)   2/44 (4.55%)   0/17 (0.00%) 
Injection site pruritus * 1               
# participants affected / at risk   1/36 (2.78%)   3/60 (5.00%)   3/40 (7.50%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Gait disturbance * 1               
# participants affected / at risk   1/36 (2.78%)   3/60 (5.00%)   0/40 (0.00%)   2/35 (5.71%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Injection site induration * 1               
# participants affected / at risk   0/36 (0.00%)   4/60 (6.67%)   1/40 (2.50%)   0/35 (0.00%)   0/12 (0.00%)   1/44 (2.27%)   0/17 (0.00%) 
Malaise * 1               
# participants affected / at risk   2/36 (5.56%)   1/60 (1.67%)   1/40 (2.50%)   0/35 (0.00%)   2/12 (16.67%)   0/44 (0.00%)   0/17 (0.00%) 
Injection site bruising * 1               
# participants affected / at risk   1/36 (2.78%)   0/60 (0.00%)   2/40 (5.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Injection site reaction * 1               
# participants affected / at risk   3/36 (8.33%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   1/44 (2.27%)   0/17 (0.00%) 
Injection site warmth * 1               
# participants affected / at risk   1/36 (2.78%)   3/60 (5.00%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Pyrexia * 1               
# participants affected / at risk   0/36 (0.00%)   3/60 (5.00%)   0/40 (0.00%)   1/35 (2.86%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Injection site inflammation * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   2/40 (5.00%)   0/35 (0.00%)   0/12 (0.00%)   1/44 (2.27%)   0/17 (0.00%) 
Irritability * 1               
# participants affected / at risk   2/36 (5.56%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Injection site haemorrhage * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   1/40 (2.50%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Infections and infestations               
Urinary tract infection * 1               
# participants affected / at risk   3/36 (8.33%)   6/60 (10.00%)   2/40 (5.00%)   4/35 (11.43%)   0/12 (0.00%)   2/44 (4.55%)   4/17 (23.53%) 
Nasopharyngitis * 1               
# participants affected / at risk   4/36 (11.11%)   6/60 (10.00%)   1/40 (2.50%)   2/35 (5.71%)   0/12 (0.00%)   4/44 (9.09%)   1/17 (5.88%) 
Upper respiratory tract infection * 1               
# participants affected / at risk   3/36 (8.33%)   3/60 (5.00%)   5/40 (12.50%)   3/35 (8.57%)   1/12 (8.33%)   1/44 (2.27%)   1/17 (5.88%) 
Sinusitis * 1               
# participants affected / at risk   0/36 (0.00%)   2/60 (3.33%)   1/40 (2.50%)   0/35 (0.00%)   1/12 (8.33%)   1/44 (2.27%)   1/17 (5.88%) 
Bronchitis * 1               
# participants affected / at risk   3/36 (8.33%)   1/60 (1.67%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   1/44 (2.27%)   0/17 (0.00%) 
Viral upper respiratory tract infection * 1               
# participants affected / at risk   1/36 (2.78%)   2/60 (3.33%)   0/40 (0.00%)   1/35 (2.86%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Influenza * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   4/44 (9.09%)   0/17 (0.00%) 
Oral herpes * 1               
# participants affected / at risk   0/36 (0.00%)   2/60 (3.33%)   0/40 (0.00%)   1/35 (2.86%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Rhinitis * 1               
# participants affected / at risk   0/36 (0.00%)   1/60 (1.67%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   2/44 (4.55%)   0/17 (0.00%) 
Lower respiratory tract infection * 1               
# participants affected / at risk   1/36 (2.78%)   0/60 (0.00%)   0/40 (0.00%)   2/35 (5.71%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Tooth infection * 1               
# participants affected / at risk   1/36 (2.78%)   0/60 (0.00%)   0/40 (0.00%)   1/35 (2.86%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Fungal skin infection * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   1/17 (5.88%) 
Furuncle * 1               
# participants affected / at risk   0/36 (0.00%)   1/60 (1.67%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Gingivitis * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   1/44 (2.27%)   0/17 (0.00%) 
Herpes simplex ophthalmic * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Injury, poisoning and procedural complications               
Fall * 1               
# participants affected / at risk   3/36 (8.33%)   3/60 (5.00%)   3/40 (7.50%)   4/35 (11.43%)   1/12 (8.33%)   9/44 (20.45%)   0/17 (0.00%) 
Contusion * 1               
# participants affected / at risk   1/36 (2.78%)   1/60 (1.67%)   3/40 (7.50%)   1/35 (2.86%)   0/12 (0.00%)   3/44 (6.82%)   1/17 (5.88%) 
Laceration * 1               
# participants affected / at risk   1/36 (2.78%)   3/60 (5.00%)   1/40 (2.50%)   0/35 (0.00%)   1/12 (8.33%)   1/44 (2.27%)   0/17 (0.00%) 
Arthropod bite * 1               
# participants affected / at risk   2/36 (5.56%)   2/60 (3.33%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   1/44 (2.27%)   1/17 (5.88%) 
Procedural pain * 1               
# participants affected / at risk   2/36 (5.56%)   0/60 (0.00%)   2/40 (5.00%)   1/35 (2.86%)   0/12 (0.00%)   1/44 (2.27%)   0/17 (0.00%) 
Excoriation * 1               
# participants affected / at risk   0/36 (0.00%)   3/60 (5.00%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Wound * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   1/40 (2.50%)   0/35 (0.00%)   1/12 (8.33%)   1/44 (2.27%)   0/17 (0.00%) 
Thermal burn * 1               
# participants affected / at risk   1/36 (2.78%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Skin injury * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Spinal compression fracture * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Tooth fracture * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Investigations               
Weight decreased * 1               
# participants affected / at risk   1/36 (2.78%)   4/60 (6.67%)   2/40 (5.00%)   0/35 (0.00%)   2/12 (16.67%)   1/44 (2.27%)   1/17 (5.88%) 
Weight increased * 1               
# participants affected / at risk   1/36 (2.78%)   1/60 (1.67%)   1/40 (2.50%)   2/35 (5.71%)   0/12 (0.00%)   2/44 (4.55%)   1/17 (5.88%) 
Blood creatine phosphokinase increased * 1               
# participants affected / at risk   3/36 (8.33%)   1/60 (1.67%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Blood urea increased * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   1/40 (2.50%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Blood albumin decreased * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Blood creatinine increased * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Haematocrit decreased * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Haemoglobin decreased * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Metabolism and nutrition disorders               
Decreased appetite * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   1/35 (2.86%)   2/12 (16.67%)   0/44 (0.00%)   0/17 (0.00%) 
Hyponatraemia * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Musculoskeletal and connective tissue disorders               
Back pain * 1               
# participants affected / at risk   2/36 (5.56%)   5/60 (8.33%)   3/40 (7.50%)   4/35 (11.43%)   0/12 (0.00%)   4/44 (9.09%)   3/17 (17.65%) 
Arthralgia * 1               
# participants affected / at risk   2/36 (5.56%)   5/60 (8.33%)   4/40 (10.00%)   1/35 (2.86%)   0/12 (0.00%)   2/44 (4.55%)   2/17 (11.76%) 
Musculoskeletal pain * 1               
# participants affected / at risk   1/36 (2.78%)   3/60 (5.00%)   2/40 (5.00%)   2/35 (5.71%)   0/12 (0.00%)   4/44 (9.09%)   0/17 (0.00%) 
Pain in extremity * 1               
# participants affected / at risk   4/36 (11.11%)   3/60 (5.00%)   1/40 (2.50%)   2/35 (5.71%)   0/12 (0.00%)   1/44 (2.27%)   0/17 (0.00%) 
Osteoarthritis * 1               
# participants affected / at risk   1/36 (2.78%)   2/60 (3.33%)   4/40 (10.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Muscle spasms * 1               
# participants affected / at risk   1/36 (2.78%)   1/60 (1.67%)   1/40 (2.50%)   0/35 (0.00%)   0/12 (0.00%)   1/44 (2.27%)   1/17 (5.88%) 
Osteoporosis * 1               
# participants affected / at risk   1/36 (2.78%)   0/60 (0.00%)   1/40 (2.50%)   0/35 (0.00%)   1/12 (8.33%)   1/44 (2.27%)   0/17 (0.00%) 
Bursitis * 1               
# participants affected / at risk   1/36 (2.78%)   0/60 (0.00%)   2/40 (5.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Arthritis * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   2/40 (5.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Torticollis * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Squamous cell carcinoma * 1               
# participants affected / at risk   0/36 (0.00%)   1/60 (1.67%)   0/40 (0.00%)   3/35 (8.57%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Basal cell carcinoma * 1               
# participants affected / at risk   0/36 (0.00%)   1/60 (1.67%)   0/40 (0.00%)   1/35 (2.86%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Nervous system disorders               
Headache * 1               
# participants affected / at risk   3/36 (8.33%)   14/60 (23.33%)   4/40 (10.00%)   2/35 (5.71%)   0/12 (0.00%)   8/44 (18.18%)   1/17 (5.88%) 
Dizziness * 1               
# participants affected / at risk   3/36 (8.33%)   7/60 (11.67%)   4/40 (10.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Cognitive disorder * 1               
# participants affected / at risk   1/36 (2.78%)   3/60 (5.00%)   1/40 (2.50%)   1/35 (2.86%)   0/12 (0.00%)   1/44 (2.27%)   1/17 (5.88%) 
Somnolence * 1               
# participants affected / at risk   1/36 (2.78%)   2/60 (3.33%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   1/44 (2.27%)   1/17 (5.88%) 
Syncope * 1               
# participants affected / at risk   0/36 (0.00%)   2/60 (3.33%)   3/40 (7.50%)   1/35 (2.86%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Aphasia * 1               
# participants affected / at risk   2/36 (5.56%)   0/60 (0.00%)   0/40 (0.00%)   1/35 (2.86%)   0/12 (0.00%)   1/44 (2.27%)   0/17 (0.00%) 
Dementia Alzheimers type * 1               
# participants affected / at risk   1/36 (2.78%)   0/60 (0.00%)   1/40 (2.50%)   1/35 (2.86%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Apraxia * 1               
# participants affected / at risk   2/36 (5.56%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Cerebral microhaemorrhage * 1               
# participants affected / at risk   0/36 (0.00%)   1/60 (1.67%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   1/44 (2.27%)   1/17 (5.88%) 
Lethargy * 1               
# participants affected / at risk   3/36 (8.33%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Presyncope * 1               
# participants affected / at risk   1/36 (2.78%)   0/60 (0.00%)   2/40 (5.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Clonus * 1               
# participants affected / at risk   1/36 (2.78%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Extrapyramidal disorder * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   1/35 (2.86%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Sciatica * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   2/35 (5.71%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Amnesia * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Memory impairment * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Mental impairment * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Migraine * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Speech disorder * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Unresponsive to stimuli * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Psychiatric disorders               
Depression * 1               
# participants affected / at risk   5/36 (13.89%)   4/60 (6.67%)   4/40 (10.00%)   8/35 (22.86%)   3/12 (25.00%)   5/44 (11.36%)   1/17 (5.88%) 
Agitation * 1               
# participants affected / at risk   4/36 (11.11%)   4/60 (6.67%)   0/40 (0.00%)   5/35 (14.29%)   2/12 (16.67%)   4/44 (9.09%)   2/17 (11.76%) 
Anxiety * 1               
# participants affected / at risk   3/36 (8.33%)   5/60 (8.33%)   1/40 (2.50%)   2/35 (5.71%)   2/12 (16.67%)   2/44 (4.55%)   0/17 (0.00%) 
Confusional state * 1               
# participants affected / at risk   2/36 (5.56%)   1/60 (1.67%)   0/40 (0.00%)   2/35 (5.71%)   0/12 (0.00%)   2/44 (4.55%)   0/17 (0.00%) 
Abnormal dreams * 1               
# participants affected / at risk   3/36 (8.33%)   0/60 (0.00%)   1/40 (2.50%)   1/35 (2.86%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Aggression * 1               
# participants affected / at risk   1/36 (2.78%)   1/60 (1.67%)   1/40 (2.50%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   2/17 (11.76%) 
Delusion * 1               
# participants affected / at risk   1/36 (2.78%)   1/60 (1.67%)   0/40 (0.00%)   1/35 (2.86%)   0/12 (0.00%)   0/44 (0.00%)   2/17 (11.76%) 
Hallucination * 1               
# participants affected / at risk   0/36 (0.00%)   1/60 (1.67%)   0/40 (0.00%)   1/35 (2.86%)   0/12 (0.00%)   2/44 (4.55%)   1/17 (5.88%) 
Hallucination, visual * 1               
# participants affected / at risk   1/36 (2.78%)   0/60 (0.00%)   0/40 (0.00%)   2/35 (5.71%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Paranoia * 1               
# participants affected / at risk   2/36 (5.56%)   1/60 (1.67%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   1/44 (2.27%)   0/17 (0.00%) 
Delirium * 1               
# participants affected / at risk   1/36 (2.78%)   0/60 (0.00%)   1/40 (2.50%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Depressive symptom * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   1/40 (2.50%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   2/17 (11.76%) 
Disorientation * 1               
# participants affected / at risk   0/36 (0.00%)   1/60 (1.67%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Hallucination, auditory * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Renal and urinary disorders               
Urinary incontinence * 1               
# participants affected / at risk   2/36 (5.56%)   1/60 (1.67%)   3/40 (7.50%)   2/35 (5.71%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Incontinence * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   1/17 (5.88%) 
Hydronephrosis * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Renal failure * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Reproductive system and breast disorders               
Breast swelling * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders               
Cough * 1               
# participants affected / at risk   6/36 (16.67%)   4/60 (6.67%)   2/40 (5.00%)   2/35 (5.71%)   2/12 (16.67%)   4/44 (9.09%)   2/17 (11.76%) 
Oropharyngeal pain * 1               
# participants affected / at risk   1/36 (2.78%)   3/60 (5.00%)   1/40 (2.50%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Rhinorrhoea * 1               
# participants affected / at risk   2/36 (5.56%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   1/44 (2.27%)   0/17 (0.00%) 
Chronic obstructive pulmonary disease * 1               
# participants affected / at risk   0/36 (0.00%)   1/60 (1.67%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Pleural effusion * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Skin and subcutaneous tissue disorders               
Rash * 1               
# participants affected / at risk   3/36 (8.33%)   1/60 (1.67%)   1/40 (2.50%)   2/35 (5.71%)   0/12 (0.00%)   1/44 (2.27%)   0/17 (0.00%) 
Skin lesion * 1               
# participants affected / at risk   4/36 (11.11%)   3/60 (5.00%)   0/40 (0.00%)   1/35 (2.86%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Hyperhidrosis * 1               
# participants affected / at risk   1/36 (2.78%)   0/60 (0.00%)   1/40 (2.50%)   1/35 (2.86%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Ecchymosis * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   1/17 (5.88%) 
Petechiae * 1               
# participants affected / at risk   1/36 (2.78%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Intertrigo * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Rash pruritic * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   1/12 (8.33%)   0/44 (0.00%)   0/17 (0.00%) 
Urticaria * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   1/17 (5.88%) 
Vascular disorders               
Hypertension * 1               
# participants affected / at risk   4/36 (11.11%)   3/60 (5.00%)   1/40 (2.50%)   3/35 (8.57%)   1/12 (8.33%)   5/44 (11.36%)   1/17 (5.88%) 
Haematoma * 1               
# participants affected / at risk   0/36 (0.00%)   1/60 (1.67%)   1/40 (2.50%)   0/35 (0.00%)   0/12 (0.00%)   4/44 (9.09%)   1/17 (5.88%) 
Orthostatic hypotension * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   2/40 (5.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 15.1



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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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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: NCT00479557     History of Changes
Other Study ID Numbers: 3134K1-200
B2571004 ( Other Identifier: Alias Study Number )
2006-002061-39 ( EudraCT Number )
Study First Received: May 24, 2007
Results First Received: May 6, 2014
Last Updated: November 30, 2015