Trial Outcomes & Findings for Compare the Efficacy and Safety of Beta-Glucan as Add-On to Statin in Subjects With Hyperlipidemia. (NCT NCT03857256)
NCT ID: NCT03857256
Last Updated: 2024-01-16
Results Overview
mg/dL
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
263 participants
Primary outcome timeframe
week 0 to week 12
Results posted on
2024-01-16
Participant Flow
Participant milestones
| Measure |
Placebo
matching placebo for 12 weeks.
Placebo: tablet manufactured to mimic the CP105F beta-glucan
|
Oat Beta-glucan 1.5g
CP105F (Oat beta-glucan) 1.5g (1 tablet of 0.5g TID) for 12 weeks.
CP105F: Natural Health Product
|
Oat Beta-glucan 3g
CP105F (Oat beta-glucan) 3g (2 tablets of 0.5g TID) for 12 weeks.
CP105F: Natural Health Product
|
Oat Beta-glucan 6g
CP105F (Oat beta-glucan) 6g (4 tablets of 0.5g TID) for 12 weeks.
CP105F: Natural Health Product
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
65
|
66
|
66
|
66
|
|
Overall Study
COMPLETED
|
64
|
63
|
65
|
63
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Compare the Efficacy and Safety of Beta-Glucan as Add-On to Statin in Subjects With Hyperlipidemia.
Baseline characteristics by cohort
| Measure |
Placebo
n=65 Participants
matching placebo for 12 weeks.
Placebo: tablet manufactured to mimic the CP105F beta-glucan
|
Oat Beta-glucan 1.5g
n=66 Participants
CP105F (Oat beta-glucan) 1.5g (1 tablet of 0.5g TID) for 12 weeks.
CP105F: Natural Health Product
|
Oat Beta-glucan 3g
n=66 Participants
CP105F (Oat beta-glucan) 3g (2 tablets of 0.5g TID) for 12 weeks.
CP105F: Natural Health Product
|
Oat Beta-glucan 6g
n=66 Participants
CP105F (Oat beta-glucan) 6g (4 tablets of 0.5g TID) for 12 weeks.
CP105F: Natural Health Product
|
Total
n=263 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 9.1 • n=99 Participants
|
59.0 years
STANDARD_DEVIATION 10.6 • n=107 Participants
|
59.8 years
STANDARD_DEVIATION 10.7 • n=206 Participants
|
61.7 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
59.8 years
STANDARD_DEVIATION 9.9 • n=31 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
169 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
94 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
64 Participants
n=7 Participants
|
254 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
66 Participants
n=7 Participants
|
250 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
Canada
|
65 participants
n=99 Participants
|
66 participants
n=107 Participants
|
66 participants
n=206 Participants
|
66 participants
n=7 Participants
|
263 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: week 0 to week 12mg/dL
Outcome measures
| Measure |
Placebo
n=65 Participants
matching placebo for 12 weeks.
Placebo: tablet manufactured to mimic the CP105F beta-glucan
|
Oat Beta-glucan 1.5g
n=66 Participants
CP105F (Oat beta-glucan) 1.5g (1 tablet of 0.5g TID) for 12 weeks.
CP105F: Natural Health Product
|
Oat Beta-glucan 3g.
n=66 Participants
CP105F (Oat beta-glucan) 3g (2 tablets of 0.5g TID) for 12 weeks.
CP105F: Natural Health Product
|
Oat Beta-glucan 6g.
n=66 Participants
CP105F (Oat beta-glucan) 6g (4 tablets of 0.5g TID) for 12 weeks.
CP105F: Natural Health Product
|
|---|---|---|---|---|
|
Change in Direct-measured LDL-C
|
-3.80 mg/dL
Interval -13.13 to 5.54
|
2.95 mg/dL
Interval -2.93 to 8.83
|
4.36 mg/dL
Interval -3.38 to 12.1
|
-1.70 mg/dL
Interval -8.88 to 5.47
|
SECONDARY outcome
Timeframe: week 0 to week 12mmol/L or mg/dL
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0 to week 12mmol/L or mg/dL
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0 to week 12nmol/l
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0 to week 12mg/L
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0 to week 12mmol/L or mg/dL
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0 to week 12mmol/L
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: week 0 to week 12mmol/L
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: week 0 to week 12mmol/L
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: week 0 to week 12mmol/L
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: week 0 to week 12percentage
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Oat Beta-glucan 1.5g
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Oat Beta-glucan 3g.
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Oat Beta-glucan 6g.
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=65 participants at risk
matching placebo for 12 weeks.
Placebo: tablet manufactured to mimic the CP105F beta-glucan
|
Oat Beta-glucan 1.5g
n=64 participants at risk
CP105F (Oat beta-glucan) 1.5g (1 tablet of 0.5g TID) for 12 weeks.
CP105F: Natural Health Product
|
Oat Beta-glucan 3g.
n=66 participants at risk
CP105F (Oat beta-glucan) 3g (2 tablets of 0.5g TID) for 12 weeks.
CP105F: Natural Health Product
|
Oat Beta-glucan 6g.
n=66 participants at risk
CP105F (Oat beta-glucan) 6g (4 tablets of 0.5g TID) for 12 weeks.
CP105F: Natural Health Product
|
|---|---|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
1.5%
1/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.5%
1/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.00%
0/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.5%
1/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.5%
1/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
Other adverse events
| Measure |
Placebo
n=65 participants at risk
matching placebo for 12 weeks.
Placebo: tablet manufactured to mimic the CP105F beta-glucan
|
Oat Beta-glucan 1.5g
n=64 participants at risk
CP105F (Oat beta-glucan) 1.5g (1 tablet of 0.5g TID) for 12 weeks.
CP105F: Natural Health Product
|
Oat Beta-glucan 3g.
n=66 participants at risk
CP105F (Oat beta-glucan) 3g (2 tablets of 0.5g TID) for 12 weeks.
CP105F: Natural Health Product
|
Oat Beta-glucan 6g.
n=66 participants at risk
CP105F (Oat beta-glucan) 6g (4 tablets of 0.5g TID) for 12 weeks.
CP105F: Natural Health Product
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Flatulence
|
12.3%
8/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
3.1%
2/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
9.1%
6/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
25.8%
17/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Gastrointestinal disorders
Abdominal Distension
|
9.2%
6/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
3.1%
2/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
10.6%
7/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
21.2%
14/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Gastrointestinal disorders
Diarrhoea
|
4.6%
3/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
3.1%
2/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
7.6%
5/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
9.1%
6/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.6%
3/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.6%
1/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.5%
1/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.5%
1/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
1.5%
1/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
3.0%
2/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
10.6%
7/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Gastrointestinal disorders
Constipation
|
3.1%
2/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
3.1%
2/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.5%
1/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.5%
1/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Gastrointestinal disorders
Faeces soft
|
1.5%
1/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
3.0%
2/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
6.1%
4/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Gastrointestinal disorders
Frequent bowel movements
|
3.1%
2/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
6.1%
4/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
2/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
3.1%
2/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
3.0%
2/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.5%
1/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
4.5%
3/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
3.0%
2/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Nervous system disorders
Headache
|
4.6%
3/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.5%
1/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
3.1%
2/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
3.0%
2/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
3.1%
2/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
3.1%
2/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.5%
1/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
3.1%
2/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
3.0%
2/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
3.1%
2/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.6%
1/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.5%
1/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
General disorders
Fatigue
|
0.00%
0/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.6%
1/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
3.0%
2/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
4.6%
3/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.5%
1/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.6%
1/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
3.0%
2/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
3.0%
2/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.5%
1/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.6%
1/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.00%
0/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.6%
1/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.6%
1/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.5%
1/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.00%
0/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.6%
1/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.6%
1/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.5%
1/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.6%
1/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.6%
1/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.6%
1/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.5%
1/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/65 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
1.6%
1/64 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
0.00%
0/66 • The time period covered was from the first dose of IP to safety follow-up visit (week 14).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restriction on the PI is that the sponsor can review material for publication or presentation before public release and can embargo the release for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor can request removal of sponsor's confidential information and the sponsor can request removal of information for which sponsor wishes to obtain intellectual protection.
- Publication restrictions are in place
Restriction type: OTHER