Trial Outcomes & Findings for Comparison of Blood Pressure Medications on Metabolism (NCT NCT00642434)
NCT ID: NCT00642434
Last Updated: 2023-12-26
Results Overview
Reporting the number of participants with a change in markers of inflammation (PAI-1) following treatment compared to baseline.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
5 months
Results posted on
2023-12-26
Participant Flow
Participant milestones
| Measure |
Metoprolol
Randomized to Metoprolol
|
Carvedilol
Radomized to Carvedilol
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
|
Overall Study
Number of Participants Treated
|
10
|
12
|
|
Overall Study
COMPLETED
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data were not collected
Baseline characteristics by cohort
| Measure |
Number of Participants Treated With Metoprolol
n=9 Participants
Randomized to Metoprolol
|
Number of Participants Treated With Carvedilol
n=11 Participants
Radomized to Carvedilol
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=9 Participants
|
11 Participants
n=11 Participants
|
20 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
Data were not collected
|
0 Participants
Data were not collected
|
0 Participants
Data were not collected
|
|
Sex: Female, Male
Male
|
0 Participants
Data were not collected
|
0 Participants
Data were not collected
|
0 Participants
Data were not collected
|
PRIMARY outcome
Timeframe: 5 monthsReporting the number of participants with a change in markers of inflammation (PAI-1) following treatment compared to baseline.
Outcome measures
| Measure |
Metoprolol
n=9 Participants
Randomized to Metoprolol
|
Carvedilol
n=11 Participants
Radomized to Carvedilol
|
|---|---|---|
|
Number of Participants Assessed for Change in Markers of Inflammation (PAI-1) Following Treatment Compared to Baseline
|
0 participants
|
0 participants
|
Adverse Events
Metoprolol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Carvedilol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kathleen Colleran
University of New Mexico Health Sciences Center
Phone: 505-272-4658
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place