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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
  Hide Serious 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.

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.

Serious 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, Serious Adverse Events               
# participants affected / at risk   6/36 (16.67%)   11/60 (18.33%)   7/40 (17.50%)   5/35 (14.29%)   5/12 (41.67%)   5/44 (11.36%)   3/17 (17.65%) 
Cardiac disorders               
Myocardial infarction * 1               
# participants affected / at risk   1/36 (2.78%)   1/60 (1.67%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Atrial fibrillation * 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%) 
Cardiac arrest * 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%)   0/17 (0.00%) 
Cyanosis * 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%)   0/17 (0.00%) 
Ear and labyrinth disorders               
Vertigo positional * 1               
# participants affected / at risk   0/36 (0.00%)   2/60 (3.33%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Gastrointestinal disorders               
Gastrointestinal haemorrhage * 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%)   0/17 (0.00%) 
Intestinal obstruction * 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%)   0/17 (0.00%) 
General disorders               
Fatigue * 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%)   0/17 (0.00%) 
Feeling cold * 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%)   0/17 (0.00%) 
Gait disturbance * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   1/35 (2.86%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Malaise * 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%)   0/17 (0.00%) 
Oedema peripheral * 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%)   0/17 (0.00%) 
Hepatobiliary disorders               
Bile duct stone * 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%)   1/44 (2.27%)   0/17 (0.00%) 
Cholelithiasis * 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%) 
Infections and infestations               
Gastroenteritis * 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%)   0/17 (0.00%) 
Urinary tract infection * 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%) 
Injury, poisoning and procedural complications               
Clavicle 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%) 
Humerus fracture * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   1/35 (2.86%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Metabolism and nutrition disorders               
Dehydration * 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%) 
Decreased appetite * 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               
Arthralgia * 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%)   0/17 (0.00%) 
Intervertebral disc protrusion * 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%)   0/17 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Basal cell carcinoma * 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%)   0/17 (0.00%) 
Carcinoid tumour pulmonary * 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%) 
Lung cancer metastatic * 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%)   1/44 (2.27%)   0/17 (0.00%) 
Lung neoplasm malignant * 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%) 
Non-Hodgkins lymphoma * 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%)   0/17 (0.00%) 
Prostate cancer * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   1/35 (2.86%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Squamous cell carcinoma * 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%)   0/17 (0.00%) 
Uterine cancer * 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%)   0/17 (0.00%) 
Nervous system disorders               
Dizziness * 1               
# participants affected / at risk   1/36 (2.78%)   1/60 (1.67%)   0/40 (0.00%)   0/35 (0.00%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Syncope * 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%)   0/17 (0.00%) 
Vasogenic cerebral oedema * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   1/40 (2.50%)   1/35 (2.86%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Ataxia * 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%)   1/44 (2.27%)   0/17 (0.00%) 
Balance disorder * 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%)   1/44 (2.27%)   0/17 (0.00%) 
Bradykinesia * 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%)   1/44 (2.27%)   0/17 (0.00%) 
Cerebrovascular accident * 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%) 
Convulsion * 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%)   0/17 (0.00%) 
Dementia Alzheimers type * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   1/35 (2.86%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Dystonia * 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%)   1/44 (2.27%)   0/17 (0.00%) 
Embolic stroke * 1               
# participants affected / at risk   0/36 (0.00%)   0/60 (0.00%)   0/40 (0.00%)   1/35 (2.86%)   0/12 (0.00%)   0/44 (0.00%)   0/17 (0.00%) 
Headache * 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%)   1/44 (2.27%)   0/17 (0.00%) 
Transient ischaemic attack * 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%)   0/17 (0.00%) 
Psychiatric disorders               
Agitation * 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%) 
Confusional state * 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%) 
Delusion * 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%) 
Hallucination * 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%) 
Restlessness * 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%)   1/44 (2.27%)   0/17 (0.00%) 
Renal and urinary disorders               
Renal failure acute * 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%)   0/17 (0.00%) 
Stress urinary incontinence * 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%)   0/17 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Pulmonary embolism * 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               
Skin erosion * 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%)   0/17 (0.00%) 
Vascular disorders               
Deep vein thrombosis * 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%) 
Hypotension * 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%)   0/17 (0.00%) 
Orthostatic hypotension * 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%)   0/17 (0.00%) 
Vasculitis * 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%)   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