Trial Outcomes & Findings for Naltrexone/Bupropion Cardiovascular Outcomes Study (NCT NCT02638129)
NCT ID: NCT02638129
Last Updated: 2017-02-27
Results Overview
MACE are defined as cardiovascular death, nonfatal myocardial infarction and nonfatal stroke.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
67 participants
Primary outcome timeframe
Day 1 to first confirmed occurrence of MACE (up to 6 years)
Results posted on
2017-02-27
Participant Flow
Sixty-seven (67) participants randomized into the double-blind lead-in period (Enrolled Set), while 58 participants were randomized into the double-blind treatment period (Full Analysis Set).
Participant milestones
| Measure |
Naltrexone/Bupropion
Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets
|
Placebo
Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
30
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
28
|
30
|
Reasons for withdrawal
| Measure |
Naltrexone/Bupropion
Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets
|
Placebo
Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets
|
|---|---|---|
|
Overall Study
Study terminated
|
28
|
30
|
Baseline Characteristics
Naltrexone/Bupropion Cardiovascular Outcomes Study
Baseline characteristics by cohort
| Measure |
Naltrexone/Bupropion
n=28 Participants
Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets
|
Placebo
n=30 Participants
Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 9.29 • n=5 Participants
|
65.5 years
STANDARD_DEVIATION 7.04 • n=7 Participants
|
63.5 years
STANDARD_DEVIATION 8.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to first confirmed occurrence of MACE (up to 6 years)Population: The trial was prematurely terminated. Due to the short trial duration and as a result of very limited participant follow-up, insufficient data was collected (or did not exist) to allow for a statistical analysis as described in the protocol. The necessary and sufficient data to conduct the primary and secondary analyses was not available.
MACE are defined as cardiovascular death, nonfatal myocardial infarction and nonfatal stroke.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to first confirmed occurrence of extended MACE (up to 6 years)Population: The trial was prematurely terminated. Due to the short trial duration and as a result of very limited participant follow-up, insufficient data was collected (or did not exist) to allow for a statistical analysis as described in the protocol. The necessary and sufficient data to conduct the primary and secondary analyses was not available.
Extended MACE defined as cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and unstable angina requiring hospitalization.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to the occurrence of all-cause death (up to 6 years)Population: The trial was prematurely terminated. Due to the short trial duration and as a result of very limited participant follow-up, insufficient data was collected (or did not exist) to allow for a statistical analysis as described in the protocol. The necessary and sufficient data to conduct the primary and secondary analyses was not available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to the occurrence of cardiovascular death (up to 6 years)Population: The trial was prematurely terminated. Due to the short trial duration and as a result of very limited participant follow-up, insufficient data was collected (or did not exist) to allow for a statistical analysis as described in the protocol. The necessary and sufficient data to conduct the primary and secondary analyses was not available.
Outcome measures
Outcome data not reported
Adverse Events
Naltrexone/Bupropion
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Naltrexone/Bupropion
n=28 participants at risk
Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets
|
Placebo
n=30 participants at risk
Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/28 • Study was terminated with the maximum subject duration on study of 13.1 weeks.
Study did not collect all non-serious adverse events. Safety data collection was limited to adverse events leading to discontinuation of study medication, special interest adverse events, and serious adverse events. All recorded non-serious AEs and SAEs are reported in the tables.
|
3.3%
1/30 • Number of events 1 • Study was terminated with the maximum subject duration on study of 13.1 weeks.
Study did not collect all non-serious adverse events. Safety data collection was limited to adverse events leading to discontinuation of study medication, special interest adverse events, and serious adverse events. All recorded non-serious AEs and SAEs are reported in the tables.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/28 • Study was terminated with the maximum subject duration on study of 13.1 weeks.
Study did not collect all non-serious adverse events. Safety data collection was limited to adverse events leading to discontinuation of study medication, special interest adverse events, and serious adverse events. All recorded non-serious AEs and SAEs are reported in the tables.
|
3.3%
1/30 • Number of events 1 • Study was terminated with the maximum subject duration on study of 13.1 weeks.
Study did not collect all non-serious adverse events. Safety data collection was limited to adverse events leading to discontinuation of study medication, special interest adverse events, and serious adverse events. All recorded non-serious AEs and SAEs are reported in the tables.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/28 • Study was terminated with the maximum subject duration on study of 13.1 weeks.
Study did not collect all non-serious adverse events. Safety data collection was limited to adverse events leading to discontinuation of study medication, special interest adverse events, and serious adverse events. All recorded non-serious AEs and SAEs are reported in the tables.
|
3.3%
1/30 • Number of events 1 • Study was terminated with the maximum subject duration on study of 13.1 weeks.
Study did not collect all non-serious adverse events. Safety data collection was limited to adverse events leading to discontinuation of study medication, special interest adverse events, and serious adverse events. All recorded non-serious AEs and SAEs are reported in the tables.
|
|
Nervous system disorders
Cerebrovascular accident
|
3.6%
1/28 • Number of events 1 • Study was terminated with the maximum subject duration on study of 13.1 weeks.
Study did not collect all non-serious adverse events. Safety data collection was limited to adverse events leading to discontinuation of study medication, special interest adverse events, and serious adverse events. All recorded non-serious AEs and SAEs are reported in the tables.
|
0.00%
0/30 • Study was terminated with the maximum subject duration on study of 13.1 weeks.
Study did not collect all non-serious adverse events. Safety data collection was limited to adverse events leading to discontinuation of study medication, special interest adverse events, and serious adverse events. All recorded non-serious AEs and SAEs are reported in the tables.
|
|
Nervous system disorders
Brain stem stroke
|
3.6%
1/28 • Number of events 2 • Study was terminated with the maximum subject duration on study of 13.1 weeks.
Study did not collect all non-serious adverse events. Safety data collection was limited to adverse events leading to discontinuation of study medication, special interest adverse events, and serious adverse events. All recorded non-serious AEs and SAEs are reported in the tables.
|
0.00%
0/30 • Study was terminated with the maximum subject duration on study of 13.1 weeks.
Study did not collect all non-serious adverse events. Safety data collection was limited to adverse events leading to discontinuation of study medication, special interest adverse events, and serious adverse events. All recorded non-serious AEs and SAEs are reported in the tables.
|
Other adverse events
| Measure |
Naltrexone/Bupropion
n=28 participants at risk
Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets
|
Placebo
n=30 participants at risk
Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/28 • Study was terminated with the maximum subject duration on study of 13.1 weeks.
Study did not collect all non-serious adverse events. Safety data collection was limited to adverse events leading to discontinuation of study medication, special interest adverse events, and serious adverse events. All recorded non-serious AEs and SAEs are reported in the tables.
|
3.3%
1/30 • Number of events 1 • Study was terminated with the maximum subject duration on study of 13.1 weeks.
Study did not collect all non-serious adverse events. Safety data collection was limited to adverse events leading to discontinuation of study medication, special interest adverse events, and serious adverse events. All recorded non-serious AEs and SAEs are reported in the tables.
|
|
General disorders
Fatigue
|
0.00%
0/28 • Study was terminated with the maximum subject duration on study of 13.1 weeks.
Study did not collect all non-serious adverse events. Safety data collection was limited to adverse events leading to discontinuation of study medication, special interest adverse events, and serious adverse events. All recorded non-serious AEs and SAEs are reported in the tables.
|
3.3%
1/30 • Number of events 1 • Study was terminated with the maximum subject duration on study of 13.1 weeks.
Study did not collect all non-serious adverse events. Safety data collection was limited to adverse events leading to discontinuation of study medication, special interest adverse events, and serious adverse events. All recorded non-serious AEs and SAEs are reported in the tables.
|
|
Gastrointestinal disorders
Faeces discoloured
|
3.6%
1/28 • Number of events 1 • Study was terminated with the maximum subject duration on study of 13.1 weeks.
Study did not collect all non-serious adverse events. Safety data collection was limited to adverse events leading to discontinuation of study medication, special interest adverse events, and serious adverse events. All recorded non-serious AEs and SAEs are reported in the tables.
|
0.00%
0/30 • Study was terminated with the maximum subject duration on study of 13.1 weeks.
Study did not collect all non-serious adverse events. Safety data collection was limited to adverse events leading to discontinuation of study medication, special interest adverse events, and serious adverse events. All recorded non-serious AEs and SAEs are reported in the tables.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If not already published by Sponsor as part of a multi-center publication, 24 months after conclusion, abandonment or termination of the study or notification that there will be no such multi-center publication, PI may publish the results for PI's study center individually. Prior to such publication, PI must provide Sponsor with at least 60 days to review and comment on the proposed publication. Sponsor may delay publication for up to an additional 6 month period to file for patent protection.
- Publication restrictions are in place
Restriction type: OTHER