Trial Outcomes & Findings for Prevention of Anthracycline or Trastuzumab Induced Cardiomyopathy by Metoprolol (NCT NCT00806390)
NCT ID: NCT00806390
Last Updated: 2022-02-25
Results Overview
Because of the inability to enroll an adequate number of patients, (only 15 out of a planned 50) no data analysis was collected or performed.
TERMINATED
PHASE4
15 participants
Pre and post anthracycline treatment
2022-02-25
Participant Flow
Participant milestones
| Measure |
Metoprolol
Receiving metoprolol
Metoprolol: Metroprolol tartrate titrated up
|
Control
Not receiving metoprolol
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Anthracycline or Trastuzumab Induced Cardiomyopathy by Metoprolol
Baseline characteristics by cohort
| Measure |
Metoprolol
n=7 Participants
Receiving metoprolol
Metoprolol: Metroprolol tartrate titrated up
|
Control
n=8 Participants
Not receiving metoprolol
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 11 • n=99 Participants
|
47 years
STANDARD_DEVIATION 8 • n=107 Participants
|
49 years
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
15 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Pre and post anthracycline treatmentPopulation: This study was unable to enroll a sufficient number of patients to permit analysis (only 15 patients enrolled)
Because of the inability to enroll an adequate number of patients, (only 15 out of a planned 50) no data analysis was collected or performed.
Outcome measures
Outcome data not reported
Adverse Events
Metoprolol
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place