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Study to Evaluate Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT01483924
Recruitment Status : Completed
First Posted : December 2, 2011
Results First Posted : February 20, 2015
Last Update Posted : February 20, 2015
Sponsor:
Information provided by (Responsible Party):
ApoPharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Intervention Drug: Apo805K1
Enrollment 60

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Apo805K1 10 mg Apo805K1 30 mg Apo805K1 60 mg Apo805K1 100 mg
Hide Arm/Group Description Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses. Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
Period Title: Overall Study
Started 12 12 12 12 12
Completed 10 12 11 8 10
Not Completed 2 0 1 4 2
Reason Not Completed
Withdrawal by Subject             2             0             0             1             1
Adverse Event             0             0             1             1             0
Non-compliance             0             0             0             1             1
Sponsor concern over ECG result             0             0             0             1             0
Arm/Group Title Placebo Apo805K1 10 mg Apo805K1 30 mg Apo805K1 60 mg Apo805K1 100 mg Total
Hide Arm/Group Description Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses. Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 12 12 12 12 12 60
Hide Baseline Analysis Population Description
A total of 60 patients were enrolled. No formal sample size calculation for this study was done, as this study was an exploratory study with main objective to assess the safety and tolerability of Apo805K1.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
12
 100.0%
12
 100.0%
12
 100.0%
12
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 60 participants
Female
3
  25.0%
5
  41.7%
8
  66.7%
3
  25.0%
0
   0.0%
19
  31.7%
Male
9
  75.0%
7
  58.3%
4
  33.3%
9
  75.0%
12
 100.0%
41
  68.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   8.3%
0
   0.0%
2
  16.7%
1
   8.3%
0
   0.0%
4
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  16.7%
4
  33.3%
0
   0.0%
1
   8.3%
3
  25.0%
10
  16.7%
White
9
  75.0%
8
  66.7%
10
  83.3%
10
  83.3%
9
  75.0%
46
  76.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 60 participants
United States 11 12 12 9 7 51
Canada 1 0 0 3 5 9
1.Primary Outcome
Title Number of Patients With Adverse Events
Hide Description The number of patients in each treatment group who reported at least 1 adverse event, including clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations and laboratory tests, from the time of the first dose until the last study visit.
Time Frame 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Safety Population consisted of all patients who received at least 1 dose of study medication.
Arm/Group Title Placebo Apo805K1 10 mg Apo805K1 30 mg Apo805K1 60 mg Apo805K1 100 mg
Hide Arm/Group Description:
Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
Overall Number of Participants Analyzed 12 12 12 12 12
Measure Type: Number
Unit of Measure: participants
4 5 7 6 5
2.Secondary Outcome
Title Cmax of Apo805K1 Following Multiple Doses, Assessed at Day 14
Hide Description

Cmax for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.

Time Frame 12 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14)
Arm/Group Title Apo805K1 10 mg Apo805K1 30 mg Apo805K1 60 mg Apo805K1 100 mg
Hide Arm/Group Description:
Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
18.3  (9.7) 53.0  (37.8) 138.5  (54.5) 164.9  (69.2)
3.Secondary Outcome
Title Tmax of Apo805K1 Following Multiple Doses, Assessed at Day 14
Time Frame 12 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apo805K1 10 mg Apo805K1 30 mg Apo805K1 60 mg Apo805K1 100 mg
Hide Arm/Group Description:
Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
Overall Number of Participants Analyzed 12 12 12 12
Median (Full Range)
Unit of Measure: hour
4.00
(3.00 to 6.00)
3.00
(3.00 to 5.00)
3.00
(3.00 to 6.00)
4.00
(3.00 to 6.00)
4.Secondary Outcome
Title AUC 0-infinity of Apo805K1 Following Multiple Doses, Assessed at Day 14
Hide Description AUC 0-infinity for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.
Time Frame 12 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14)
Arm/Group Title Apo805K1 10 mg Apo805K1 30 mg Apo805K1 60 mg Apo805K1 100 mg
Hide Arm/Group Description:
Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
Overall Number of Participants Analyzed 11 12 12 12
Mean (Standard Deviation)
Unit of Measure: ng *hr/mL
134.7  (68.1) 368.4  (244.6) 973.7  (463.1) 1294.0  (658.7)
5.Secondary Outcome
Title T 1/2 of Apo805K1 Following Multiple Doses, Assessed at Day 14
Time Frame 12 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14)
Arm/Group Title Apo805K1 10 mg Apo805K1 30 mg Apo805K1 60 mg Apo805K1 100 mg
Hide Arm/Group Description:
Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
Overall Number of Participants Analyzed 11 12 12 12
Mean (Standard Deviation)
Unit of Measure: hour
2.8  (0.5) 2.6  (0.2) 2.8  (1.1) 2.8  (0.5)
6.Secondary Outcome
Title Efficacy of Apo805K1 as Assessed by Change From Baseline in Psoriasis Area Severity Index (PASI) Scores
Hide Description PASI is a quantitative measure of psoriasis that combines an assessment of the severity of lesions and a measurement of how much of the body surface area is affected into a single score ranging from 0 (no disease) to 72 (maximal disease). Thus, a decrease in PASI score indicates improvement. This outcome measure compared the difference in change in PASI score from baseline to Week 12 between the active treatment groups and the placebo group.
Time Frame Baseline to 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.
Arm/Group Title Placebo Apo805K1 10 mg Apo805K1 30 mg Apo805K1 60 mg Apo805K1 100 mg
Hide Arm/Group Description:
Three patients in each of the 4 dose-escalating cohorts were randomized to take placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
Patients in this treatment group took a single 10 mg tablet of Apo805K1 daily for 12 weeks
Patients in this treatment group took three 10 mg tablets of Apo805K1 daily for 12 weeks
Patients in this treatment group took one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
Patients in this treatment group took two 50 mg tablets of Apo805K1 daily for 12 weeks
Overall Number of Participants Analyzed 12 12 12 11 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.8  (4.6) -3.8  (6.9) -2.0  (5.3) -3.4  (3.5) -2.8  (5.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apo805K1 10 mg, Apo805K1 30 mg, Apo805K1 60 mg, Apo805K1 100 mg
Comments The difference in change in PASI score from baseline to Week 12 was compared all active treatment groups and the placebo group
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9048
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Efficacy of APO805K1 as Assessed by Achievement of PASI-75
Hide Description The proportion of patients in each treatment group who achieved at least a 75% improvement in PASI score from baseline at Week 12
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.
Arm/Group Title Placebo Apo805K1 10 mg Apo805K1 30 mg Apo805K1 60 mg Apo805K1 100 mg
Hide Arm/Group Description:
Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
Overall Number of Participants Analyzed 12 12 12 11 12
Measure Type: Number
Unit of Measure: percentage of patients
16.7 16.7 0.0 0.0 8.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apo805K1 10 mg, Apo805K1 30 mg, Apo805K1 60 mg, Apo805K1 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1975
Comments [Not Specified]
Method Cochran-Armitage trend test
Comments [Not Specified]
8.Secondary Outcome
Title Efficacy of Apo805K1 as Assessed by Change From Baseline at Week 12 in Lattice System–Physician Global Assessment (LS-PGA) Scores
Hide Description The LS-PGA is a standardized method for determining categories of psoriasis severity. The percentage of body surface area involved is assessed on a scale ranging from 1 (0%) to 7 (51–100%); measures of plaque severity (thickness, erythema, and scaling) are assessed using a 4-point scale ranging from “none” to “marked”; and an algorithm is used to combine the above scores to determine a final score on a scale ranging from 0 (clear) to 7 (very severe). Thus, a decrease in LS-PGA score indicates improvement. This outcome measure compared the difference in change in LS-PGA score from baseline to Week 12 between the active treatment groups and the placebo group.
Time Frame Baseline to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.
Arm/Group Title Placebo Apo805K1 10 mg Apo805K1 30 mg Apo805K1 60 mg Apo805K1 100 mg
Hide Arm/Group Description:
Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
Overall Number of Participants Analyzed 12 12 12 11 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.8  (0.8) -1.2  (1.6) -0.6  (0.7) -0.5  (0.9) -0.7  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apo805K1 10 mg, Apo805K1 30 mg, Apo805K1 60 mg, Apo805K1 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6349
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
9.Secondary Outcome
Title Efficacy of Apo805K1 as Assessed by Change From Baseline to Week 12 in Physician Global Assessment (PGA) Score
Hide Description In the PGA, the physician assigns a single estimate of a patient’s overall severity of the disease using a scale ranging from 0 (Clear) to 7 (Severe). (Unlike the LS-PGA, the individual elements of psoriasis plaque morphology or degree of body surface area involvement are not quantified.) Thus, a decrease in PGA score indicates improvement. This outcome measure compared the difference in change in PGA score from baseline to Week 12 between the active treatment groups and the placebo group.
Time Frame Baseline to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.
Arm/Group Title Placebo Apo805K1 10 mg Apo805K1 30 mg Apo805K1 60 mg Apo805K1 100 mg
Hide Arm/Group Description:
Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
Overall Number of Participants Analyzed 12 12 12 11 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.0  (1.0) -0.8  (1.0) -0.5  (1.1) -0.9  (0.8) -1.3  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apo805K1 10 mg, Apo805K1 60 mg, Apo805K1 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6212
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Time Frame Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug
Adverse Event Reporting Description Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
 
Arm/Group Title Placebo Apo805K1 10 mg Apo805K1 30 mg Apo805K1 60 mg Apo805K1 100 mg
Hide Arm/Group Description Three patients in each of the 4 dose-escalating cohorts were randomized to take placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses. Patients in this treatment group took a single 10 mg tablet of Apo805K1 daily for 12 weeks Patients in this treatment group took three 10 mg tablets of Apo805K1 daily for 12 weeks Patients in this treatment group took one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks Patients in this treatment group took two 50 mg tablets of Apo805K1 daily for 12 weeks
All-Cause Mortality
Placebo Apo805K1 10 mg Apo805K1 30 mg Apo805K1 60 mg Apo805K1 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Apo805K1 10 mg Apo805K1 30 mg Apo805K1 60 mg Apo805K1 100 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)      1/12 (8.33%)      0/12 (0.00%)      0/12 (0.00%)    
Skin and subcutaneous tissue disorders           
Pustular psoriasis  1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Apo805K1 10 mg Apo805K1 30 mg Apo805K1 60 mg Apo805K1 100 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/12 (33.33%)      5/12 (41.67%)      7/12 (58.33%)      6/12 (50.00%)      5/12 (41.67%)    
Cardiac disorders           
Bundle branch block right  1  0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 1/12 (8.33%)  1
Eye disorders           
Blepharitis  1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Blepharospasm  1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Conjunctivitis  1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Dry eye  1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Optic nerve cupping  1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Gastrointestinal disorders           
Abdominal pain  1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Constipation  1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Diarrhoea  1  2/12 (16.67%)  2 0/12 (0.00%)  0 1/12 (8.33%)  2 0/12 (0.00%)  0 0/12 (0.00%)  0
Dry mouth  1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Nausea  1  0/12 (0.00%)  0 1/12 (8.33%)  1 1/12 (8.33%)  1 2/12 (16.67%)  2 0/12 (0.00%)  0
Rectal haemorrhage  1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Stomatitis  1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Vomiting  1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Bronchitis  1  1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
General disorders           
Oedema peripheral  1  1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Pain  1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  2 0/12 (0.00%)  0 0/12 (0.00%)  0
Vessel puncture site pain  1  0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Infections and infestations           
Gastroenteritis  1  0/12 (0.00%)  0 2/12 (16.67%)  2 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Nasopharyngitis  1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 2/12 (16.67%)  2 0/12 (0.00%)  0
Upper respiratory tract infection  1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Injury, poisoning and procedural complications           
Contusion  1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Laceration  1  0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Metabolism and nutrition disorders           
Decreased appetite  1  0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Muscle twitching  1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Pain in extremity  1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Nervous system disorders           
Dizziness  1  1/12 (8.33%)  1 1/12 (8.33%)  1 0/12 (0.00%)  0 2/12 (16.67%)  4 2/12 (16.67%)  2
Headache  1  1/12 (8.33%)  1 1/12 (8.33%)  1 2/12 (16.67%)  2 0/12 (0.00%)  0 0/12 (0.00%)  0
Paraesthesia  1  0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Psychiatric disorders           
Depression  1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Insomnia  1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Panic attack  1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Reproductive system and breast disorders           
Breast cyst  1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Asthma  1  0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Nasal congestion  1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Respiratory tract congestion  1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Throat irritation  1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders           
Alopecia  1  0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Psoriasis  1  0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 2/12 (16.67%)  2 0/12 (0.00%)  0
Pustular psoriasis  1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Skin haemorrhage  1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
Results Point of Contact
Name/Title: Fernando Tricta, MD
Organization: ApoPharma Inc.
Phone: Phone: 416-401-7332
Responsible Party: ApoPharma
ClinicalTrials.gov Identifier: NCT01483924     History of Changes
Other Study ID Numbers: AP03-0210
First Submitted: November 30, 2011
First Posted: December 2, 2011
Results First Submitted: January 20, 2015
Results First Posted: February 20, 2015
Last Update Posted: February 20, 2015