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The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia

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: NCT02300233
Recruitment Status : Completed
First Posted : November 24, 2014
Results First Posted : April 13, 2022
Last Update Posted : April 13, 2022
Sponsor:
Collaborator:
Akcea Therapeutics
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypertriglyceridemia
Interventions Drug: Volanesorsen
Drug: Placebo
Enrollment 114
Recruitment Details A total of 114 participants were randomized at multiple study centers worldwide.
Pre-assignment Details 114 participants were randomized, and 113 received study drug. One patient was randomized, but discontinued before dosing, and thus included only in the volanesorsen Total (Not public) column. The study included a ≤ 8-week screening period (including a diet-stabilization period), a 26-week treatment period, and a 13-week post-treatment evaluation period.
Arm/Group Title Placebo Volanesorsen 300 mg Weekly Volanesorsen 300 mg Biweekly, Post Week 13
Hide Arm/Group Description Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks. Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks. Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
Period Title: Overall Study
Started 38 25 50
Completed [1] 34 24 27
Not Completed 4 1 23
Reason Not Completed
Adverse Event or Serious Adverse Event             3             1             14
Withdrawal by Subject             1             0             3
Investigator Judgement             0             0             1
Reason Not Specified             0             0             5
[1]
Completed here refers to participants who completed the study treatment.
Arm/Group Title Placebo Volanesorsen 300 mg Weekly Volanesorsen 300 mg Biweekly, Post Week 13 Total
Hide Arm/Group Description Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks. Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks. Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks. Total of all reporting groups
Overall Number of Baseline Participants 38 25 50 113
Hide Baseline Analysis Population Description
The full analysis set (FAS) included all participants who were randomized, received at least one dose of study drug, and had a baseline triglycerides (TG) assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 25 participants 50 participants 113 participants
53  (10) 50  (9) 51  (11) 51  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 25 participants 50 participants 113 participants
Female
8
  21.1%
5
  20.0%
14
  28.0%
27
  23.9%
Male
30
  78.9%
20
  80.0%
36
  72.0%
86
  76.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 25 participants 50 participants 113 participants
Hispanic or Latino
1
   2.6%
1
   4.0%
0
   0.0%
2
   1.8%
Not Hispanic or Latino
37
  97.4%
24
  96.0%
50
 100.0%
111
  98.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 25 participants 50 participants 113 participants
White
33
  86.8%
25
 100.0%
47
  94.0%
105
  92.9%
Asian
3
   7.9%
0
   0.0%
1
   2.0%
4
   3.5%
American Indian or Alaskan Native
0
   0.0%
0
   0.0%
1
   2.0%
1
   0.9%
Other Race
1
   2.6%
0
   0.0%
1
   2.0%
2
   1.8%
Multiple
1
   2.6%
0
   0.0%
0
   0.0%
1
   0.9%
Fasting Triglycerides  
Mean (Standard Deviation)
Unit of measure:  Milligrams per deciliter (mg/dL)
Number Analyzed 38 participants 25 participants 50 participants 113 participants
1414  (1253) 1046  (560) 1251  (838) 1261  (955)
1.Primary Outcome
Title Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3
Hide Description [Not Specified]
Time Frame Baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment.
Arm/Group Title Placebo Volanesorsen Total
Hide Arm/Group Description:
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks; or once-weekly for 13 weeks, then bi-weekly for 13 weeks.
Overall Number of Participants Analyzed 38 75
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
-0.9
(-13.9 to 12.2)
-71.2
(-79.3 to -63.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Volanesorsen Total
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean (LSM)
Estimated Value -70.3
Confidence Interval (2-Sided) 95%
-85.4 to -55.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Absolute Change in Fasting TG From Baseline to Month 3
Hide Description [Not Specified]
Time Frame Baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment. Volanesorsen 300 mg biweekly group includes patients who received weekly dosing in first 13 weeks, and then bi-weekly for 13 weeks. For month 3 assessments, the results were combined since all patients were on weekly dosing. And for month 6 assessments, the results were split to show the results in each dosing group.
Arm/Group Title Placebo Volanesorsen Total
Hide Arm/Group Description:
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks; or once-weekly for 13 weeks, then bi-weekly for 13 weeks.
Overall Number of Participants Analyzed 38 75
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
74
(-138 to 285)
-869
(-1018 to -720)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Volanesorsen Total
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -943
Confidence Interval (2-Sided) 95%
-1197 to -689
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Treatment Response Rate Defined as Participants With Fasting TG ≥ 40% Reduction From Baseline at Month 3
Hide Description [Not Specified]
Time Frame Baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment.
Arm/Group Title Placebo Volanesorsen Total
Hide Arm/Group Description:
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks; or once-weekly for 13 weeks, then bi-weekly for 13 weeks.
Overall Number of Participants Analyzed 38 75
Measure Type: Count of Participants
Unit of Measure: Participants
5
  13.2%
65
  86.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Volanesorsen Total
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 96.02
Confidence Interval (2-Sided) 95%
19.71 to 467.79
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percent Change in High-density Lipoprotein-cholesterol (HDL-C) From Baseline
Hide Description [Not Specified]
Time Frame Baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment.
Arm/Group Title Placebo Volanesorsen Total
Hide Arm/Group Description:
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks; or once-weekly for 13 weeks, then bi-weekly for 13 weeks.
Overall Number of Participants Analyzed 38 75
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
4.4
(-5.2 to 14.0)
61.2
(54.2 to 68.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Volanesorsen Total
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value 56.8
Confidence Interval (2-Sided) 95%
45.1 to 68.6
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Treatment Response Rate Defined as Participants With Fasting TG < 150 mg/dL Reduction From Baseline at Month 3
Hide Description mg/dL = milligrams per deciliter
Time Frame Baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment.
Arm/Group Title Placebo Volanesorsen Total
Hide Arm/Group Description:
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks; or once-weekly for 13 weeks, then bi-weekly for 13 weeks.
Overall Number of Participants Analyzed 38 75
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
11
  14.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Volanesorsen Total
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0474
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 14.93
Confidence Interval (2-Sided) 95%
1.03 to 215.88
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)
Hide Description HOMA-IR was calculated using the following formula: fasting insulin micro-international units per millimeter (μIU/mL) x fasting glucose mg/dL]/405. A negative change from baseline indicates improvement; a positive change from baseline indicates worsening.
Time Frame Baseline to 3 and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment. Number analyzed were the participants evaluated at the given time point.
Arm/Group Title Placebo Volanesorsen 300 mg Weekly Volanesorsen 300 mg Biweekly, Post Week 13
Hide Arm/Group Description:
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks.
Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
Overall Number of Participants Analyzed 38 25 50
Mean (Standard Deviation)
Unit of Measure: score
Month 3 Number Analyzed 36 participants 24 participants 42 participants
-0.29  (3.12) 1.53  (4.89) -0.45  (4.97)
Month 6 Number Analyzed 35 participants 24 participants 38 participants
-0.37  (3.18) 1.54  (7.69) 0.56  (2.97)
7.Secondary Outcome
Title Change From Baseline in Glycated Hemoglobin (HbA1c) in Type 2 Diabetes Mellitus (T2DM) Participants
Hide Description [Not Specified]
Time Frame Baseline to 3 and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment. Number analyzed were the T2DM participants evaluated at the given time point.
Arm/Group Title Placebo Volanesorsen 300 mg Weekly Volanesorsen 300 mg Biweekly, Post Week 13
Hide Arm/Group Description:
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks.
Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
Overall Number of Participants Analyzed 14 9 21
Mean (Standard Deviation)
Unit of Measure: percentage
Month 3 Number Analyzed 13 participants 9 participants 21 participants
-0.0  (0.5) 0.4  (0.6) 0.1  (0.5)
Month 6 Number Analyzed 12 participants 9 participants 19 participants
-0.2  (0.6) 0.8  (0.9) 0.3  (0.9)
Time Frame Up to approximately 39 weeks.
Adverse Event Reporting Description The safety set included all randomized participants who received at least one dose of study drug.
 
Arm/Group Title Placebo Volanesorsen 300 mg Weekly Volanesorsen 300 mg Biweekly, Post Week 13
Hide Arm/Group Description Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks. Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks. Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
All-Cause Mortality
Placebo Volanesorsen 300 mg Weekly Volanesorsen 300 mg Biweekly, Post Week 13
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/25 (0.00%)   0/50 (0.00%) 
Hide Serious Adverse Events
Placebo Volanesorsen 300 mg Weekly Volanesorsen 300 mg Biweekly, Post Week 13
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/38 (10.53%)   2/25 (8.00%)   6/50 (12.00%) 
Ear and labyrinth disorders       
Vertigo  1  0/38 (0.00%)  0/25 (0.00%)  1/50 (2.00%) 
Gastrointestinal disorders       
Ileus paralytic  1  1/38 (2.63%)  0/25 (0.00%)  0/50 (0.00%) 
Pancreatitis acute  1  2/38 (5.26%)  1/25 (4.00%)  0/50 (0.00%) 
Pancreatitis relapsing  1  1/38 (2.63%)  0/25 (0.00%)  0/50 (0.00%) 
Small intestinal obstruction  1  0/38 (0.00%)  0/25 (0.00%)  1/50 (2.00%) 
General disorders       
Non-cardiac chest pain  1  0/38 (0.00%)  0/25 (0.00%)  1/50 (2.00%) 
Hepatobiliary disorders       
Cholelithiasis  1  1/38 (2.63%)  0/25 (0.00%)  0/50 (0.00%) 
Immune system disorders       
Serum sickness  1  0/38 (0.00%)  0/25 (0.00%)  1/50 (2.00%) 
Infections and infestations       
Pancreas infection  1  1/38 (2.63%)  0/25 (0.00%)  0/50 (0.00%) 
Injury, poisoning and procedural complications       
Ulna fracture  1  0/38 (0.00%)  1/25 (4.00%)  0/50 (0.00%) 
Nervous system disorders       
Carotid artery stenosis  1  0/38 (0.00%)  0/25 (0.00%)  1/50 (2.00%) 
Hemiparesis  1  0/38 (0.00%)  0/25 (0.00%)  1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  1/38 (2.63%)  0/25 (0.00%)  0/50 (0.00%) 
Vascular disorders       
Hypertensive crisis  1  0/38 (0.00%)  0/25 (0.00%)  1/50 (2.00%) 
Peripheral arterial occlusive disease  1  0/38 (0.00%)  0/25 (0.00%)  1/50 (2.00%) 
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Volanesorsen 300 mg Weekly Volanesorsen 300 mg Biweekly, Post Week 13
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   31/38 (81.58%)   24/25 (96.00%)   49/50 (98.00%) 
Blood and lymphatic system disorders       
Thrombocytopenia  1  2/38 (5.26%)  2/25 (8.00%)  8/50 (16.00%) 
Anaemia  1  2/38 (5.26%)  2/25 (8.00%)  2/50 (4.00%) 
Ear and labyrinth disorders       
Vertigo  1  2/38 (5.26%)  0/25 (0.00%)  0/50 (0.00%) 
Gastrointestinal disorders       
Diarrhoea  1  4/38 (10.53%)  5/25 (20.00%)  5/50 (10.00%) 
Abdominal pain  1  1/38 (2.63%)  1/25 (4.00%)  9/50 (18.00%) 
Nausea  1  1/38 (2.63%)  1/25 (4.00%)  6/50 (12.00%) 
Vomiting  1  1/38 (2.63%)  1/25 (4.00%)  4/50 (8.00%) 
Abdominal pain upper  1  3/38 (7.89%)  0/25 (0.00%)  2/50 (4.00%) 
Dry mouth  1  0/38 (0.00%)  1/25 (4.00%)  3/50 (6.00%) 
General disorders       
Injection site erythema  1  2/38 (5.26%)  23/25 (92.00%)  38/50 (76.00%) 
Injection site pain  1  2/38 (5.26%)  10/25 (40.00%)  29/50 (58.00%) 
Injection site swelling  1  1/38 (2.63%)  12/25 (48.00%)  24/50 (48.00%) 
Injection site pruritus  1  0/38 (0.00%)  10/25 (40.00%)  17/50 (34.00%) 
Injection site discolouration  1  0/38 (0.00%)  12/25 (48.00%)  11/50 (22.00%) 
Injection site induration  1  2/38 (5.26%)  7/25 (28.00%)  11/50 (22.00%) 
Injection site discomfort  1  1/38 (2.63%)  2/25 (8.00%)  11/50 (22.00%) 
Fatigue  1  4/38 (10.53%)  2/25 (8.00%)  7/50 (14.00%) 
Injection site bruising  1  1/38 (2.63%)  1/25 (4.00%)  10/50 (20.00%) 
Injection site rash  1  0/38 (0.00%)  3/25 (12.00%)  6/50 (12.00%) 
Pyrexia  1  2/38 (5.26%)  2/25 (8.00%)  5/50 (10.00%) 
Injection site reaction  1  0/38 (0.00%)  4/25 (16.00%)  4/50 (8.00%) 
Injection site warmth  1  0/38 (0.00%)  2/25 (8.00%)  6/50 (12.00%) 
Asthenia  1  2/38 (5.26%)  3/25 (12.00%)  2/50 (4.00%) 
Injection site haemorrhage  1  0/38 (0.00%)  2/25 (8.00%)  5/50 (10.00%) 
Injection site hypoaesthesia  1  0/38 (0.00%)  1/25 (4.00%)  5/50 (10.00%) 
Injection site inflammation  1  1/38 (2.63%)  2/25 (8.00%)  2/50 (4.00%) 
Pain  1  2/38 (5.26%)  0/25 (0.00%)  2/50 (4.00%) 
Injection site mass  1  0/38 (0.00%)  2/25 (8.00%)  1/50 (2.00%) 
Injection site oedema  1  0/38 (0.00%)  0/25 (0.00%)  3/50 (6.00%) 
Hepatobiliary disorders       
Hepatic pain  1  0/38 (0.00%)  2/25 (8.00%)  0/50 (0.00%) 
Infections and infestations       
Nasopharyngitis  1  5/38 (13.16%)  8/25 (32.00%)  4/50 (8.00%) 
Bronchitis  1  3/38 (7.89%)  1/25 (4.00%)  3/50 (6.00%) 
Upper respiratory tract infection  1  2/38 (5.26%)  2/25 (8.00%)  2/50 (4.00%) 
Urinary tract infection  1  2/38 (5.26%)  2/25 (8.00%)  0/50 (0.00%) 
Influenza  1  2/38 (5.26%)  0/25 (0.00%)  1/50 (2.00%) 
Injury, poisoning and procedural complications       
Contusion  1  1/38 (2.63%)  2/25 (8.00%)  1/50 (2.00%) 
Investigations       
Red blood cell sedimentation rate increased  1  4/38 (10.53%)  6/25 (24.00%)  5/50 (10.00%) 
C-reactive protein increased  1  0/38 (0.00%)  3/25 (12.00%)  5/50 (10.00%) 
Low density lipoprotein increased  1  0/38 (0.00%)  3/25 (12.00%)  4/50 (8.00%) 
Platelet count decreased  1  2/38 (5.26%)  1/25 (4.00%)  2/50 (4.00%) 
Hepatic enzyme increased  1  0/38 (0.00%)  1/25 (4.00%)  3/50 (6.00%) 
Blood creatinine increased  1  0/38 (0.00%)  0/25 (0.00%)  3/50 (6.00%) 
Metabolism and nutrition disorders       
Diabetes mellitus  1  0/38 (0.00%)  1/25 (4.00%)  3/50 (6.00%) 
Gout  1  2/38 (5.26%)  1/25 (4.00%)  1/50 (2.00%) 
Type 2 diabetes mellitus  1  2/38 (5.26%)  2/25 (8.00%)  0/50 (0.00%) 
Decreased appetite  1  0/38 (0.00%)  2/25 (8.00%)  0/50 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  4/38 (10.53%)  4/25 (16.00%)  8/50 (16.00%) 
Arthralgia  1  0/38 (0.00%)  2/25 (8.00%)  7/50 (14.00%) 
Pain in extremity  1  1/38 (2.63%)  2/25 (8.00%)  5/50 (10.00%) 
Myalgia  1  0/38 (0.00%)  2/25 (8.00%)  4/50 (8.00%) 
Nervous system disorders       
Headache  1  4/38 (10.53%)  2/25 (8.00%)  5/50 (10.00%) 
Dizziness  1  2/38 (5.26%)  2/25 (8.00%)  2/50 (4.00%) 
Psychiatric disorders       
Depression  1  0/38 (0.00%)  2/25 (8.00%)  3/50 (6.00%) 
Renal and urinary disorders       
Albuminuria  1  0/38 (0.00%)  2/25 (8.00%)  1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  3/38 (7.89%)  0/25 (0.00%)  2/50 (4.00%) 
Skin and subcutaneous tissue disorders       
Erythema  1  0/38 (0.00%)  2/25 (8.00%)  2/50 (4.00%) 
Rash  1  0/38 (0.00%)  3/25 (12.00%)  0/50 (0.00%) 
Actinic keratosis  1  2/38 (5.26%)  0/25 (0.00%)  0/50 (0.00%) 
Dermatitis  1  0/38 (0.00%)  2/25 (8.00%)  0/50 (0.00%) 
Vascular disorders       
Hot flush  1  2/38 (5.26%)  0/25 (0.00%)  1/50 (2.00%) 
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Ionis Pharmaceuticals, Inc.
Organization: Ionis Pharmaceuticals, Inc.
Phone: 800-679-4747
EMail: patients@ionisph.com
Layout table for additonal information
Responsible Party: Ionis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02300233    
Other Study ID Numbers: ISIS 304801-CS16
2014-003434-93 ( EudraCT Number )
First Submitted: November 20, 2014
First Posted: November 24, 2014
Results First Submitted: January 13, 2022
Results First Posted: April 13, 2022
Last Update Posted: April 13, 2022