Trial Outcomes & Findings for Pharmacological and Behavioral Treatment After Bariatric Surgery: Acute (Stage 1) (NCT NCT04599478)
NCT ID: NCT04599478
Last Updated: 2026-08-26
Results Overview
Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
92 participants
Primary outcome timeframe
Post-treatment (4 months)
Results posted on
2026-08-26
Participant Flow
Participant milestones
| Measure |
Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) Medication
Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form.
|
BWL + Placebo
Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form.
|
NB Medication
Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form.
|
Placebo
Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
22
|
24
|
22
|
|
Overall Study
COMPLETED
|
17
|
15
|
19
|
15
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
5
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacological and Behavioral Treatment After Bariatric Surgery: Acute (Stage 1)
Baseline characteristics by cohort
| Measure |
Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) Medication
n=24 Participants
Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form.
|
BWL + Placebo
n=22 Participants
Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form.
|
NB Medication
n=24 Participants
Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form.
|
Placebo
n=22 Participants
Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.42 Years
STANDARD_DEVIATION 10.54 • n=31 Participants
|
48.64 Years
STANDARD_DEVIATION 9.63 • n=49 Participants
|
47.67 Years
STANDARD_DEVIATION 9.54 • n=80 Participants
|
45.32 Years
STANDARD_DEVIATION 12.41 • n=29 Participants
|
46.75 Years
STANDARD_DEVIATION 10.49 • n=106 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=31 Participants
|
20 Participants
n=49 Participants
|
21 Participants
n=80 Participants
|
22 Participants
n=29 Participants
|
80 Participants
n=106 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
3 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
12 Participants
n=106 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
1 Participants
n=106 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=31 Participants
|
5 Participants
n=49 Participants
|
4 Participants
n=80 Participants
|
10 Participants
n=29 Participants
|
26 Participants
n=106 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=31 Participants
|
17 Participants
n=49 Participants
|
20 Participants
n=80 Participants
|
12 Participants
n=29 Participants
|
65 Participants
n=106 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=31 Participants
|
5 Participants
n=49 Participants
|
2 Participants
n=80 Participants
|
5 Participants
n=29 Participants
|
17 Participants
n=106 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=31 Participants
|
17 Participants
n=49 Participants
|
22 Participants
n=80 Participants
|
17 Participants
n=29 Participants
|
75 Participants
n=106 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
PRIMARY outcome
Timeframe: Post-treatment (4 months)Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Outcome measures
| Measure |
Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) Medication
n=17 Participants
Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form.
|
BWL + Placebo
n=15 Participants
Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form.
|
NB Medication
n=19 Participants
Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form.
|
Placebo
n=15 Participants
Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.
|
|---|---|---|---|---|
|
Loss-of-control Eating Frequency
|
3.71 episodes per the past 28 days
Standard Deviation 3.05
|
5.33 episodes per the past 28 days
Standard Deviation 6.49
|
5.58 episodes per the past 28 days
Standard Deviation 7.07
|
10.73 episodes per the past 28 days
Standard Deviation 11.85
|
PRIMARY outcome
Timeframe: Post-treatment (4 months)Percent weight loss is calculated based on change from pre-treatment to post-treatment at 4 months. Negative values indicate weight loss.
Outcome measures
| Measure |
Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) Medication
n=17 Participants
Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form.
|
BWL + Placebo
n=15 Participants
Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form.
|
NB Medication
n=19 Participants
Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form.
|
Placebo
n=15 Participants
Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.
|
|---|---|---|---|---|
|
Percent Weight Loss
|
-6.19 percentage
Standard Deviation 4.70
|
-1.74 percentage
Standard Deviation 4.42
|
-3.94 percentage
Standard Deviation 4.98
|
-1.36 percentage
Standard Deviation 4.86
|
SECONDARY outcome
Timeframe: Post-treatment (4 months)Categorical: zero episodes/28 days
Outcome measures
| Measure |
Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) Medication
n=24 Participants
Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form.
|
BWL + Placebo
n=22 Participants
Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form.
|
NB Medication
n=24 Participants
Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form.
|
Placebo
n=22 Participants
Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.
|
|---|---|---|---|---|
|
Number of Participants With Loss-of-control Eating Remission
|
5 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Post-treatment (4 months)Categorical: 5% weight loss
Outcome measures
| Measure |
Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) Medication
n=24 Participants
Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form.
|
BWL + Placebo
n=22 Participants
Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form.
|
NB Medication
n=24 Participants
Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form.
|
Placebo
n=22 Participants
Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.
|
|---|---|---|---|---|
|
Number of Participants With 5% Weight Loss
|
18 Participants
|
10 Participants
|
12 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Post-treatment (4 months)Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).
Outcome measures
| Measure |
Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) Medication
n=17 Participants
Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form.
|
BWL + Placebo
n=15 Participants
Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form.
|
NB Medication
n=19 Participants
Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form.
|
Placebo
n=15 Participants
Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.
|
|---|---|---|---|---|
|
Eating Disorder Psychopathology
|
0.95 scores on a scale ranging from 0-6
Standard Deviation 0.68
|
1.34 scores on a scale ranging from 0-6
Standard Deviation 0.85
|
1.44 scores on a scale ranging from 0-6
Standard Deviation 0.89
|
1.74 scores on a scale ranging from 0-6
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: Post-treatment (4 months)Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Patient Health Questionnaire - 9. Scores range from 0-27 (0=no depressive symptoms, 27=greater depressive symptoms).
Outcome measures
| Measure |
Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) Medication
n=16 Participants
Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form.
|
BWL + Placebo
n=15 Participants
Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form.
|
NB Medication
n=18 Participants
Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form.
|
Placebo
n=13 Participants
Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.
|
|---|---|---|---|---|
|
Depressive Symptoms
|
3.19 scores on a scale ranging from 0-27
Standard Deviation 3.25
|
3.93 scores on a scale ranging from 0-27
Standard Deviation 3.01
|
3.23 scores on a scale ranging from 0-27
Standard Deviation 3.51
|
3.77 scores on a scale ranging from 0-27
Standard Deviation 4.11
|
Adverse Events
NB Medication
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) Medication
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
BWL + Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NB Medication
n=23 participants at risk
Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form.
|
Placebo
n=22 participants at risk
Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.
|
Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) Medication
n=21 participants at risk
Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form.
|
BWL + Placebo
n=17 participants at risk
Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
17.4%
4/23 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
18.2%
4/22 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
14.3%
3/21 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
17.6%
3/17 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
|
Gastrointestinal disorders
Constipation
|
52.2%
12/23 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
22.7%
5/22 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
33.3%
7/21 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
29.4%
5/17 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
1/23 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
9.1%
2/22 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
14.3%
3/21 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
17.6%
3/17 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
|
Gastrointestinal disorders
Nausea
|
39.1%
9/23 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
4.5%
1/22 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
33.3%
7/21 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
0.00%
0/17 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
0.00%
0/22 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
9.5%
2/21 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
0.00%
0/17 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
|
Psychiatric disorders
Anxiety
|
21.7%
5/23 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
13.6%
3/22 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
23.8%
5/21 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
23.5%
4/17 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
|
Psychiatric disorders
Depression
|
0.00%
0/23 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
0.00%
0/22 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
4.8%
1/21 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
17.6%
3/17 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
4.3%
1/23 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
0.00%
0/22 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
4.8%
1/21 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
17.6%
3/17 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
|
General disorders
Dizziness
|
47.8%
11/23 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
22.7%
5/22 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
14.3%
3/21 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
23.5%
4/17 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
|
General disorders
Dry Mouth
|
43.5%
10/23 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
13.6%
3/22 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
33.3%
7/21 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
17.6%
3/17 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
|
General disorders
Headache
|
39.1%
9/23 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
13.6%
3/22 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
28.6%
6/21 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
23.5%
4/17 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
|
General disorders
Insomnia
|
26.1%
6/23 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
18.2%
4/22 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
23.8%
5/21 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
17.6%
3/17 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
|
Nervous system disorders
Fatigue
|
17.4%
4/23 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
9.1%
2/22 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
9.5%
2/21 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
29.4%
5/17 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
|
Nervous system disorders
Hot Flush
|
26.1%
6/23 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
18.2%
4/22 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
9.5%
2/21 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
11.8%
2/17 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
8.7%
2/23 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
0.00%
0/22 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
0.00%
0/21 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
5.9%
1/17 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
|
Cardiac disorders
Hypertensive Crisis
|
0.00%
0/23 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
0.00%
0/22 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
4.8%
1/21 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
11.8%
2/17 • From enrollment until end of treatment, up to 16 weeks
The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place