Trial Outcomes & Findings for Nicotinamide Riboside in Systolic Heart Failure (NCT NCT03423342)
NCT ID: NCT03423342
Last Updated: 2022-11-16
Results Overview
Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
up to 12 weeks
Results posted on
2022-11-16
Participant Flow
Participant milestones
| Measure |
Nicotinamide Riboside
Nicotinamide riboside will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
nicotinamide riboside: nicotinamide riboside capsule
|
Placebo
Matching placebo will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
Placebo: matching placebo capsule
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
10
|
|
Overall Study
COMPLETED
|
20
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nicotinamide Riboside in Systolic Heart Failure
Baseline characteristics by cohort
| Measure |
Nicotinamide Riboside
n=20 Participants
Nicotinamide riboside will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
nicotinamide riboside: nicotinamide riboside capsule
|
Placebo
n=10 Participants
Matching placebo will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
Placebo: matching placebo capsule
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=99 Participants
|
60 years
n=107 Participants
|
59 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
10 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Sitting Blood Pressure Systolic
|
106 mmHg
n=99 Participants
|
106 mmHg
n=107 Participants
|
106 mmHg
n=206 Participants
|
|
Sitting Blood Pressure Diastolic
|
67 mmHg
n=99 Participants
|
64 mmHg
n=107 Participants
|
66 mmHg
n=206 Participants
|
|
Heart rate
|
67 beats/min
n=99 Participants
|
66 beats/min
n=107 Participants
|
67 beats/min
n=206 Participants
|
|
Weight
|
95 kg
n=99 Participants
|
96 kg
n=107 Participants
|
95 kg
n=206 Participants
|
|
Height
|
170 cm
n=99 Participants
|
176 cm
n=107 Participants
|
172 cm
n=206 Participants
|
|
Smoking: Never
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Alcohol: Never
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Non-ischemic heart failure
|
13 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Left ventricular (LV) ejection fraction [LV stroke volume (SV)/LV end-diastolic volume (LVEDV)]
|
28 percentage of ejection fraction
n=99 Participants
|
28 percentage of ejection fraction
n=107 Participants
|
28 percentage of ejection fraction
n=206 Participants
|
|
Previous myocardial infarction
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Previous coronary artery bypass surgery
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Previous percutaneous coronary intervention
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
History of hypertension
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
History of dyslipidemia
|
11 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
History of atherosclerotic disease (coronary, peripheral or carotid)
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
History of atrial fibrillation
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
History of atrial flutter
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
History of diabetes
|
8 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Liver disease
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Emphysema
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Serum potassium
|
4.2 mEq/L
n=99 Participants
|
4.3 mEq/L
n=107 Participants
|
4.2 mEq/L
n=206 Participants
|
|
Serum glucose
|
131.7 mg/dL
n=99 Participants
|
114.1 mg/dL
n=107 Participants
|
125.8 mg/dL
n=206 Participants
|
|
Serum creatinine
|
1.1 mg/dL
n=99 Participants
|
1.2 mg/dL
n=107 Participants
|
1.1 mg/dL
n=206 Participants
|
|
Alanine aminotransferase, U/L
|
19.9 U/L
n=99 Participants
|
27.3 U/L
n=107 Participants
|
22.4 U/L
n=206 Participants
|
|
Body temperature
|
37 degrees Celsius
n=99 Participants
|
36 degrees Celsius
n=107 Participants
|
37 degrees Celsius
n=206 Participants
|
|
White blood count
|
6.8 cells x 1000/uL
n=99 Participants
|
6.4 cells x 1000/uL
n=107 Participants
|
6.7 cells x 1000/uL
n=206 Participants
|
|
Hematocrit
|
41 %
n=99 Participants
|
42 %
n=107 Participants
|
41 %
n=206 Participants
|
|
Hemoglobin
|
13.5 g/dL
n=99 Participants
|
13.8 g/dL
n=107 Participants
|
13.6 g/dL
n=206 Participants
|
|
Platelet count, thousand/uL
|
194 cells x 1000/uL
n=99 Participants
|
194 cells x 1000/uL
n=107 Participants
|
194 cells x 1000/uL
n=206 Participants
|
|
Aspartate aminotransferase
|
19.2 U/L
n=99 Participants
|
24.9 U/L
n=107 Participants
|
21.1 U/L
n=206 Participants
|
|
Insulin resistance (homeostasis model assessment)
|
7.0 units
n=99 Participants
|
4.4 units
n=107 Participants
|
6.1 units
n=206 Participants
|
|
Estimated glomerular filtration rate
|
71 mL/min/1.73_m2
n=99 Participants
|
67 mL/min/1.73_m2
n=107 Participants
|
70 mL/min/1.73_m2
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: Total Adverse Events, per participant
Adverse Events
Outcome measures
| Measure |
Nicotinamide Riboside
n=20 Participants
Nicotinamide riboside will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
nicotinamide riboside: nicotinamide riboside capsule
|
Placebo
n=10 Participants
Matching placebo will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
Placebo: matching placebo capsule
|
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
|
3.1 events/participant
Interval 0.0 to 9.0
|
3.2 events/participant
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: Week 12-Week 0Population: Post enrollment, one of the study participants randomized to NR withdraw before the study drug was dispensed.
Between-group comparison of On-Trial Change in Whole Blood NAD+ Levels
Outcome measures
| Measure |
Nicotinamide Riboside
n=19 Participants
Nicotinamide riboside will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
nicotinamide riboside: nicotinamide riboside capsule
|
Placebo
n=10 Participants
Matching placebo will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
Placebo: matching placebo capsule
|
|---|---|---|
|
On-Trial Change in Whole Blood NAD+ Levels
|
29.0 uM
Standard Error 3.2
|
-0.3 uM
Standard Error 0.6
|
SECONDARY outcome
Timeframe: 16 weeksIncidence of On-Trial Abnormal Laboratory Values and/or Adverse Events that Are Related to Treatment
Outcome measures
| Measure |
Nicotinamide Riboside
n=20 Participants
Nicotinamide riboside will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
nicotinamide riboside: nicotinamide riboside capsule
|
Placebo
n=10 Participants
Matching placebo will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
Placebo: matching placebo capsule
|
|---|---|---|
|
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 12 - Week 0Population: One study subject randomized to NR withdrew post enrollment.
Mitochondrial Respiration in Isolated Peripheral Blood Mononuclear Cells by the Seahorse (R) Assay
Outcome measures
| Measure |
Nicotinamide Riboside
n=19 Participants
Nicotinamide riboside will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
nicotinamide riboside: nicotinamide riboside capsule
|
Placebo
n=10 Participants
Matching placebo will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
Placebo: matching placebo capsule
|
|---|---|---|
|
Effect of NR on Change in Mitochondrial Function (Maximal Oxygen Consumption Rate)
|
21 pmol/min/1,000,000 cells
Standard Error 42
|
2 pmol/min/1,000,000 cells
Standard Error 23
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12 - Week 0Change in Six Minute Walk Distance
Outcome measures
| Measure |
Nicotinamide Riboside
n=17 Participants
Nicotinamide riboside will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
nicotinamide riboside: nicotinamide riboside capsule
|
Placebo
n=9 Participants
Matching placebo will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
Placebo: matching placebo capsule
|
|---|---|---|
|
Exploratory Endpoint: Effect of NR on Functional Capacity
|
6 meters
Standard Error 8
|
1 meters
Standard Error 15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12 - Week 0Population: One study subject randomized to NR withdrew post-enrollment. We were unable to obtain the LVEF for one of the enrolled patient randomized to NR.
Change in Left Ventricular Ejection Fraction by 3D-Transthoracic Echocardiography
Outcome measures
| Measure |
Nicotinamide Riboside
n=18 Participants
Nicotinamide riboside will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
nicotinamide riboside: nicotinamide riboside capsule
|
Placebo
n=10 Participants
Matching placebo will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
Placebo: matching placebo capsule
|
|---|---|---|
|
Exploratory Endpoint: Effect of NR on Change in Left Ventricular Systolic Function
|
0.0 percentage of ejection fraction
Standard Error 2.2
|
0.3 percentage of ejection fraction
Standard Error 2.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12 - Week 0Tissue Doppler Imaging, e'
Outcome measures
| Measure |
Nicotinamide Riboside
n=17 Participants
Nicotinamide riboside will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
nicotinamide riboside: nicotinamide riboside capsule
|
Placebo
n=9 Participants
Matching placebo will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
Placebo: matching placebo capsule
|
|---|---|---|
|
Exploratory Endpoint: Effect of NR on Left Ventricular Diastolic Function
|
0.37 cm/sec
Standard Error 0.54
|
-0.44 cm/sec
Standard Error 0.39
|
Adverse Events
Nicotinamide Riboside
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nicotinamide Riboside
n=20 participants at risk
Nicotinamide riboside will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
nicotinamide riboside: nicotinamide riboside capsule
|
Placebo
n=10 participants at risk
Matching placebo will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
Placebo: matching placebo capsule
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgia, severe
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/10 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary edema
|
0.00%
0/20 • 16 weeks
|
10.0%
1/10 • Number of events 1 • 16 weeks
|
|
Cardiac disorders
Heart failure
|
0.00%
0/20 • 16 weeks
|
10.0%
1/10 • Number of events 1 • 16 weeks
|
Other adverse events
| Measure |
Nicotinamide Riboside
n=20 participants at risk
Nicotinamide riboside will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
nicotinamide riboside: nicotinamide riboside capsule
|
Placebo
n=10 participants at risk
Matching placebo will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
Placebo: matching placebo capsule
|
|---|---|---|
|
Nervous system disorders
Nervous system disorders
|
30.0%
6/20 • Number of events 12 • 16 weeks
|
50.0%
5/10 • Number of events 5 • 16 weeks
|
|
Infections and infestations
Infections and infestations
|
30.0%
6/20 • Number of events 12 • 16 weeks
|
50.0%
5/10 • Number of events 5 • 16 weeks
|
|
Renal and urinary disorders
Renal and urinary disorders
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
10.0%
1/10 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
25.0%
5/20 • Number of events 6 • 16 weeks
|
10.0%
1/10 • Number of events 1 • 16 weeks
|
|
General disorders
General disorders and administration site conditions
|
45.0%
9/20 • Number of events 12 • 16 weeks
|
40.0%
4/10 • Number of events 5 • 16 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
15.0%
3/20 • Number of events 4 • 16 weeks
|
20.0%
2/10 • Number of events 3 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
15.0%
3/20 • Number of events 4 • 16 weeks
|
30.0%
3/10 • Number of events 8 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
10.0%
1/10 • Number of events 1 • 16 weeks
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
10.0%
2/20 • Number of events 2 • 16 weeks
|
10.0%
1/10 • Number of events 1 • 16 weeks
|
|
Cardiac disorders
Cardiac disorders
|
15.0%
3/20 • Number of events 3 • 16 weeks
|
10.0%
1/10 • Number of events 1 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place