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Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration

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: NCT01577381
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : April 13, 2012
Results First Posted : March 16, 2016
Last Update Posted : March 16, 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 Age-Related Maculopathy
Interventions Biological: RN6G
Biological: Placebo
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Period Title: Overall Study
Started 2 3 3 2
Completed 0 0 0 0
Not Completed 2 3 3 2
Reason Not Completed
Discontinued             2             1             2             2
Ongoing at Date of Cut-Off             0             2             1             0
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo Total
Hide Arm/Group Description PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses. Total of all reporting groups
Overall Number of Baseline Participants 2 3 3 2 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 3 participants 3 participants 2 participants 10 participants
82.5  (0.7) 71.0  (6.2) 74.0  (12.2) 73.0  (11.3) 74.6  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 3 participants 2 participants 10 participants
Female
1
  50.0%
3
 100.0%
3
 100.0%
0
   0.0%
7
  70.0%
Male
1
  50.0%
0
   0.0%
0
   0.0%
2
 100.0%
3
  30.0%
1.Primary Outcome
Title Mean Reduction (in Study Eye) in Rate of Growth of Geographic Atrophy (GA) at Day 309
Hide Description GA is the advanced form of dry age-related macular degeneration (AMD). The reduction in GA area of the study eye was based on Fundus Autofluorescence (FAF) at 30 days post last dose administration (Day 309).
Time Frame Baseline and Day 309
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Mean Reduction (in Study Eye) in Rate of Growth of GA at Day 449 (End of Study)
Hide Description GA is the advanced form of dry AMD. The reduction in GA area in the study eye was based on FAF at end of study (Day 449).
Time Frame Baseline and Day 449
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Mean Best Corrected Visual Acuity (BCVA) at 9, 12, 15 Months and End of Study
Hide Description BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
Time Frame Baseline, Month 9, Month 12, Month 15, and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Percentage Change From Baseline in BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study
Hide Description BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
Time Frame Baseline, Month 9, Month 12, Month 15, and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Percentage Change From Baseline in BCVA Correct Number of Lines at Months 9, 12, 15 Months and End of Study
Hide Description BCVA is measured using an eye chart and is reported as the number of lines read correctly in the study eye. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity).
Time Frame Baseline, Month 9, Month 12, Month 15, and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Mean Low Luminance Best Corrected Visual Acuity (LL-BCVA) at 9, 12, 15 Months and End of Study
Hide Description LL-BCVA is the measure of visual acuity under low light conditions.
Time Frame Baseline, Month 9, Month 12, Month 15, and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Percentage Change From Baseline in LL-BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study
Hide Description LL-BCVA is the measure of visual acuity under low light conditions.
Time Frame Baseline, Month 9, Month 12, Month 15, and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Percentage Change From Baseline in LL-BCVA Correct Number of Lines at 9, 12, 15 Months and End of Study
Hide Description LL-BCVA is the measure of visual acuity under low light conditions.
Time Frame Baseline, Month 9, Month 12, Month 15, and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study
Hide Description Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Participants were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.
Time Frame Baseline, Month 9, Month 12, Month 15, and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Percentage Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study
Hide Description Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Subjects were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.
Time Frame Baseline, Month 9, Month 12, Month 15, and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study
Hide Description Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.
Time Frame Baseline, Month 9, Month 12, Month 15, and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Change From Placebo in Reading Speed at 9, 12, 15 Months and End of Study
Hide Description Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.
Time Frame Baseline, Month 9, Month 12, Month 15, and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Percentage Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study
Hide Description Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.
Time Frame Baseline, Month 9, Month 12, Month 15, and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study
Hide Description Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD (logrithmic Reading Acuity Determination).
Time Frame Baseline, Month 9, Month 12, Month 15, and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Change From Placebo in Reading Acuity at 9, 12, 15 Months and End of Study
Hide Description Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD.
Time Frame Baseline, Month 9, Month 12, Month 15, and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Percentage Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study
Hide Description Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD.
Time Frame Baseline, Month 9, Month 12, Month 15, and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Change From Baseline in Critical Print Size Reading at 9, 12, 15 Months and End of Study
Hide Description The critical print size is the smallest print size at which participants can read with their maximum reading speed.
Time Frame Baseline, Month 9, Month 12, Month 15, and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Change From Placebo in Critical Print Size Reading at 9, 12, 15 Months and End of Study
Hide Description The critical print size is the smallest print size at which participants can read with their maximum reading speed.
Time Frame Baseline, Month 9, Month 12, Month 15, and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Number of Participants With Treatment-Emergent Laboratory Abnormalities
Hide Description Laboratory assessments include: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); coagulation assessments.
Time Frame Day 85 and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Number of Participants With Abnormal Change From Baseline in Vital Signs
Hide Description Vital sign assessments include: supine systolic and diastolic blood pressure, pulse rate and body temperature.
Time Frame Screening, Days 28, 57, 85, 113, 141, and 169
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
21.Secondary Outcome
Title Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings
Hide Description Clinically significant ECG findings include: corrected QT (QTc) > 450 msec, QTc >500 msec, change in QTc between 30 and 60 msec, change in QTc greater than or equal to 60 msec.
Time Frame Days 28, 57, 85, 113 and 169
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title Number of Participants With Positive Anti-Drug Antibody (ADA)
Hide Description The number of participants with positive ADA was to be summarized for each treatment arm.
Time Frame Day 57 and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
23.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to Seriousness
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame Days 28, 57, 85, 113, 141 and 169
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who received at least 1 dose of study drug.
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 2 3 3 2
Measure Type: Number
Unit of Measure: Participants
AE 2 0 1 1
SAE 1 0 0 0
24.Secondary Outcome
Title Number of Participants With Treatment-Related TEAEs
Hide Description An AE was an untoward medical occurrence in a participant who received study drug without regard to causal relationship. An investigator's relationship assessment is the determination of whether there exists a reasonable possibility that the investigational product caused or contributed to an AE.
Time Frame Days 28, 57, 85, 113, 141 and 169
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who received at least one dose of study product.
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 2 3 3 2
Measure Type: Number
Unit of Measure: Participants
0 0 0 0
25.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description [Not Specified]
Time Frame Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
26.Secondary Outcome
Title Minimum Observed Plasma Trough Concentration (Cmin)
Hide Description [Not Specified]
Time Frame Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
27.Secondary Outcome
Title Area Under the Concentration-Time Curve From Time Zero Until Last Sampling Time (AUCt)
Hide Description [Not Specified]
Time Frame Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
28.Secondary Outcome
Title Clearance at Steady State (CLss)
Hide Description Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug (R0/Css)
Time Frame Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
29.Secondary Outcome
Title Accumulation Ratio (Rac) for AUCt
Hide Description [Not Specified]
Time Frame Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
30.Secondary Outcome
Title Plasma Population PK Parameters
Hide Description Population PK parameters were to be evaluated for Cmax, AUCt, Cmin, CLss, and Rac for AUCt between the first and last (11th) doses.
Time Frame Days 1, 28, 57, 85, 169, 253, 281, 309, 337 and 449
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
31.Secondary Outcome
Title Change From Baseline in Total Amyloid Beta (A-Beta) 1-x Plasma Concentration at End of Study (Day 449)
Hide Description Concentration of total amino acid peptide, known as A-Beta 1-x, in plasma.
Time Frame Baseline, Day 449
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
32.Secondary Outcome
Title Change From Baseline in Amyloid Beta (A-Beta) 1-40 Plasma Concentration at End of Study (Day 449)
Hide Description Concentration of amino acid peptide, known as A-Beta 1-40, in plasma.
Time Frame Baseline, Day 449
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
33.Secondary Outcome
Title Change From Baseline in Amyloid Beta (A-Beta) 1-42 Plasma Concentration at End of Study (Day 449)
Hide Description Concentration of amino acid peptide, known as A-Beta 1-42, in plasma.
Time Frame Baseline, Day 449
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description:
PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
 
Arm/Group Title PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Hide Arm/Group Description PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
All-Cause Mortality
PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/2 (50.00%)   0/3 (0.00%)   0/3 (0.00%)   0/2 (0.00%) 
Nervous system disorders         
Carotid artery stenosis * 1  1/2 (50.00%)  0/3 (0.00%)  0/3 (0.00%)  0/2 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/2 (100.00%)   0/3 (0.00%)   1/3 (33.33%)   1/2 (50.00%) 
Gastrointestinal disorders         
Irritable bowel syndrome * 1  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/2 (0.00%) 
Infections and infestations         
Influenza * 1  1/2 (50.00%)  0/3 (0.00%)  0/3 (0.00%)  0/2 (0.00%) 
Upper respiratory tract infection * 1  1/2 (50.00%)  0/3 (0.00%)  0/3 (0.00%)  0/2 (0.00%) 
Urinary tract infection * 1  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders         
Tendonitis * 1  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/2 (50.00%) 
Nervous system disorders         
Headache * 1  1/2 (50.00%)  0/3 (0.00%)  1/3 (33.33%)  0/2 (0.00%) 
Renal and urinary disorders         
Nephropathy * 1  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain * 1  1/2 (50.00%)  0/3 (0.00%)  0/3 (0.00%)  0/2 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 17.0
The study was terminated early due to an organizational decision, which was not based on safety or efficacy concerns. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses.
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.
Restriction Description: 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
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01577381    
Other Study ID Numbers: B1181003
2012-000823-42 ( EudraCT Number )
First Submitted: April 11, 2012
First Posted: April 13, 2012
Results First Submitted: December 9, 2015
Results First Posted: March 16, 2016
Last Update Posted: March 16, 2016