Trial Outcomes & Findings for Nebivolol Versus Metoprolol: Comparative Effects on Fatigue and Quality of Life (NCT NCT00999102)
NCT ID: NCT00999102
Last Updated: 2018-10-19
Results Overview
A 16 item scale that measures 4 dimensions of fatigue: severity, distress, timing, and degree of interference in activities of daily living. Range: 1 (no fatigue) to 50 (extreme fatigue).
COMPLETED
PHASE4
37 participants
After 4 weeks of treatment on each drug/dose combination
2018-10-19
Participant Flow
Subjects were recruited from the patient population of the Hypertension Center, and from an announcement at the medical center. Subjects were entered from 10/09 to 9/10, and the final subject completed the protocol in 1/11.
Subjects who were on anti-hypertensives were instructed to continue their medications. Subjects taking a beta-blocker were instructed to stop them. There was no washout period. Individuals with a contraindication to beta-blockers were excluded. 4 subjects dropped out before starting medication for reasons unrelated to the study.
Participant milestones
| Measure |
Nebivolol, Followed by Metoprolol
Participants first received Nebivolol at a dose of 5 mg daily for 4 weeks, followed by 10 mg daily for another 4 weeks (i.e., weeks 1-8 in total). The participants then received Metoprolol at a dose of 50 mg daily for 4 weeks, followed by 100 mg daily for another 4 weeks (i.e., weeks 9-16 in total).
|
Metoprolol, Followed by Nebivolol
Participants first received Metoprolol at a dose of 50 mg daily for 4 weeks, followed by 100 mg daily for another 4 weeks (i.e., weeks 1-8 in total). The participants then received Nebivolol at a dose of 5 mg daily for 4 weeks, followed by 10 mg daily for another 4 weeks (i.e., weeks 9-16 in total)
|
|---|---|---|
|
4 Weeks at Lower Dose of First Drug
STARTED
|
16
|
17
|
|
4 Weeks at Lower Dose of First Drug
COMPLETED
|
15
|
16
|
|
4 Weeks at Lower Dose of First Drug
NOT COMPLETED
|
1
|
1
|
|
4 Weeks at Higher Dose of First Drug
STARTED
|
15
|
16
|
|
4 Weeks at Higher Dose of First Drug
COMPLETED
|
15
|
16
|
|
4 Weeks at Higher Dose of First Drug
NOT COMPLETED
|
0
|
0
|
|
4 Weeks at Lower Dose of Second Drug
STARTED
|
15
|
16
|
|
4 Weeks at Lower Dose of Second Drug
COMPLETED
|
15
|
16
|
|
4 Weeks at Lower Dose of Second Drug
NOT COMPLETED
|
0
|
0
|
|
4 Weeks at Higher Dose of Second Drug
STARTED
|
15
|
16
|
|
4 Weeks at Higher Dose of Second Drug
COMPLETED
|
15
|
16
|
|
4 Weeks at Higher Dose of Second Drug
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nebivolol Versus Metoprolol: Comparative Effects on Fatigue and Quality of Life
Baseline characteristics by cohort
| Measure |
All Study Participants
n=33 Participants
Participants who were randomized to receive either Nebivolol followed by Metoprolol or Metoprolol followed by Nebivolol.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 4 weeks of treatment on each drug/dose combinationPopulation: All participants who received both interventions and completed all study visits were included in the efficacy analysis.
A 16 item scale that measures 4 dimensions of fatigue: severity, distress, timing, and degree of interference in activities of daily living. Range: 1 (no fatigue) to 50 (extreme fatigue).
Outcome measures
| Measure |
Nebivolol 5 mg for 4 Weeks
n=31 Participants
31 subjects received Nebivolol 5 mg daily for 4 weeks.
|
Metoprolol 50 mg for 4 Weeks
n=31 Participants
31 subjects received Metoprolol 50 mg daily for 4 weeks
|
Nebivolol 10 mg for 4 Weeks
n=31 Participants
31 subjects received Nebivolol 10 mg daily for 4 weeks.
|
Metoprolol 100 mg for 4 Weeks
n=31 Participants
31 subjects received Metoprolol 100 mg daily for 4 weeks
|
|---|---|---|---|---|
|
Multidimensional Assessment of Fatigue (MAF) Questionnaire: Global Fatigue Score After 4 Weeks of Treatment on Each Drug/Dose Combination.
|
18.5 units on a scale
Standard Deviation 11.2
|
18.0 units on a scale
Standard Deviation 11.2
|
21.0 units on a scale
Standard Deviation 11.8
|
20.3 units on a scale
Standard Deviation 11.9
|
PRIMARY outcome
Timeframe: After 4 weeks of treatment on each drug/dose combinationPopulation: All participants who received both interventions and completed all study visits were included in the efficacy analysis.
Treadmill Exercise Time After 4 Weeks of Treatment on Each Drug/Dose Combination (in minutes). The Treadmill Test was Performed at the 4-week Visit of Each Drug/Dose Combination.
Outcome measures
| Measure |
Nebivolol 5 mg for 4 Weeks
n=31 Participants
31 subjects received Nebivolol 5 mg daily for 4 weeks.
|
Metoprolol 50 mg for 4 Weeks
n=31 Participants
31 subjects received Metoprolol 50 mg daily for 4 weeks
|
Nebivolol 10 mg for 4 Weeks
n=31 Participants
31 subjects received Nebivolol 10 mg daily for 4 weeks.
|
Metoprolol 100 mg for 4 Weeks
n=31 Participants
31 subjects received Metoprolol 100 mg daily for 4 weeks
|
|---|---|---|---|---|
|
Treadmill Exercise Time After 4 Weeks of Treatment on Each Drug/Dose Combination.
|
833.9 minutes
Standard Deviation 266.1
|
840.9 minutes
Standard Deviation 288.6
|
841.2 minutes
Standard Deviation 265.4
|
867.1 minutes
Standard Deviation 249.8
|
Adverse Events
Nebivolol 5 mg for 4 Weeks
Metoprolol 50 mg for 4 Weeks
Nebivolol 10 mg for 4 Weeks
Metoprolol 100 mg for 4 Weeks
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nebivolol 5 mg for 4 Weeks
n=33 participants at risk
31 subjects received Nebivolol 5 mg daily for 4 weeks.
|
Metoprolol 50 mg for 4 Weeks
n=33 participants at risk
31 subjects received Metoprolol 50 mg daily for 4 weeks
|
Nebivolol 10 mg for 4 Weeks
n=31 participants at risk；n=33 participants at risk
31 subjects received Nebivolol 10 mg daily for 4 weeks.
|
Metoprolol 100 mg for 4 Weeks
n=31 participants at risk；n=33 participants at risk
31 subjects received Metoprolol 100 mg daily for 4 weeks
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
3.0%
1/33 • After 4 weeks on either study drug.
All-Cause Mortality; Serious; Other.
|
3.0%
1/33 • After 4 weeks on either study drug.
All-Cause Mortality; Serious; Other.
|
0.00%
0/31 • After 4 weeks on either study drug.
All-Cause Mortality; Serious; Other.
|
0.00%
0/31 • After 4 weeks on either study drug.
All-Cause Mortality; Serious; Other.
|
Additional Information
Dr. Samuel Mann, PI
NY Presbyterian Hospital - Weill Cornell Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place