Trial Outcomes & Findings for The Impact of Nebivolol Versus Metoprolol on Quality of Life (NCT NCT01441570)

Last Updated: 2017-04-20

Results Overview

Primary outcome measure will be the change from the Screening/Enrollment Visit to the End of the Study/Early Termination visit in scores of four quality of life questionnaires. The four quality of life questionnaires that were used included the following: 1. Short Form (SF)-36v2 Health Survey (Score Range = 0-100; the lower the score the more disability) 2. Sexual Dysfunction Tool for Men = International Index of Erectile Function (IIEF) Questionnaire (Score Range = 5-25; a score of 22-25 = No erectile dysfunction; 17-21 = Mild erectile dysfunction; 12-16 = Mild to moderate erectile dysfunction; 8-11 = Moderate erectile dysfunction; 5-7 = Severe erectile dysfunction) 3. Sexual Dysfunction Tool for Women = Changes in Sexual Functioning Questionnaire (CSFQ-14-F; Score Range = 14-70; a score at or below 42 is indicative of sexual dysfunction) 4. Multidimensional Assessment of Fatigue (MAF) Scale (Score Range = 1-50; the higher the score the more fatigue)

Recruitment status

TERMINATED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

12 weeks; Baseline scores were measured at the Initial Screening/Enrollment Visit (Visit 1 - beginning of week 1); Follow-Up scores were measured at the End of the Study (Visit 2 - End of week 12)

Results posted on

2017-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	Nebivolol Nebivolol: Subject will take nebivolol daily for 12 weeks.	Metoprolol Succinate Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
Overall Study STARTED	6	5
Overall Study COMPLETED	6	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Impact of Nebivolol Versus Metoprolol on Quality of Life

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nebivolol n=6 Participants Nebivolol: Subject will take nebivolol daily for 12 weeks.	Metoprolol Succinate n=5 Participants Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=93 Participants	5 Participants n=4 Participants	11 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Region of Enrollment United States	6 participants n=93 Participants	5 participants n=4 Participants	11 participants n=27 Participants

PRIMARY outcome

Timeframe: 12 weeks; Baseline scores were measured at the Initial Screening/Enrollment Visit (Visit 1 - beginning of week 1); Follow-Up scores were measured at the End of the Study (Visit 2 - End of week 12)

Population: Adult (\>18 years of age) renal transplant recipients, both men and women, requiring pharmacotherapy for high blood pressure were evaluated for inclusion in this analysis.

Outcome measures

Outcome measures
Measure	Nebivolol n=6 Participants Nebivolol: Subject will take nebivolol daily for 12 weeks.	Metoprolol n=5 Participants Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
Quality of Life Baseline SF-36 (physical) Score	41.1 units on a scale Standard Deviation 5.3	45.9 units on a scale Standard Deviation 13.3
Quality of Life Follow-Up SF-36 (physical) Score	46.6 units on a scale Standard Deviation 13.6	43.6 units on a scale Standard Deviation 15.1
Quality of Life Change from Baseline SF-36 (physical)	5.5 units on a scale Standard Deviation 10.1	-2.3 units on a scale Standard Deviation 8.4
Quality of Life Baseline SF-36 (mental) Score	40.6 units on a scale Standard Deviation 12	40.3 units on a scale Standard Deviation 11.1
Quality of Life Follow-Up SF-36 (mental) Score	48 units on a scale Standard Deviation 11.7	42.7 units on a scale Standard Deviation 13.3
Quality of Life Change from Baseline SF-36 (mental)	7.4 units on a scale Standard Deviation 8	2.4 units on a scale Standard Deviation 7.1
Quality of Life Baseline MAF Score	27.7 units on a scale Standard Deviation 8.3	31.7 units on a scale Standard Deviation 8.6
Quality of Life Follow-Up MAF Score	22.1 units on a scale Standard Deviation 12.2	17.8 units on a scale Standard Deviation 12.2
Quality of Life Change from Baseline MAF	-5.6 units on a scale Standard Deviation 6.3	-13.9 units on a scale Standard Deviation 9.1
Quality of Life Baseline IIEF Score	10.3 units on a scale Standard Deviation 15.3	15 units on a scale Standard Deviation 9.8
Quality of Life Follow-Up IIEF Score	16.3 units on a scale Standard Deviation 14.6	14.3 units on a scale Standard Deviation 12.3
Quality of Life Change from Baseline IIEF	6.7 units on a scale Standard Deviation 9.9	-1.3 units on a scale Standard Deviation 0.6
Quality of Life Baseline CSFQ	48.7 units on a scale Standard Deviation 0.6	49 units on a scale Standard Deviation 0
Quality of Life Follow-Up CSFQ	53.0 units on a scale Standard Deviation 5.7	49 units on a scale Standard Deviation 0
Quality of Life Change from Baseline CSFQ	4.5 units on a scale Standard Deviation 6.4	0 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 12 weeks

Evaluate the baseline and follow-up systolic and diastolic blood pressures for all subjects in both groups.

Outcome measures

Outcome measures
Measure	Nebivolol n=6 Participants Nebivolol: Subject will take nebivolol daily for 12 weeks.	Metoprolol n=5 Participants Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
Blood Pressure Change from Baseline Systolic Blood Pressure	3.6 mmHg Standard Deviation 8.9	-2.8 mmHg Standard Deviation 9.9
Blood Pressure Baseline Diastolic Blood Pressure	73.2 mmHg Standard Deviation 8.5	77.0 mmHg Standard Deviation 9.9
Blood Pressure Baseline Systolic Blood Pressure	142.3 mmHg Standard Deviation 14.6	138.8 mmHg Standard Deviation 14.3
Blood Pressure Follow-Up Systolic Blood Pressure	142.8 mmHg Standard Deviation 10.7	136.0 mmHg Standard Deviation 13.9
Blood Pressure Follow-Up Diastolic Blood Pressure	76.0 mmHg Standard Deviation 5.7	73.0 mmHg Standard Deviation 13.7
Blood Pressure Change from Baseline Diastolic Blood Pressure	1.6 mmHg Standard Deviation 4.8	-4.0 mmHg Standard Deviation 11.2

Adverse Events

Nebivolol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Metoprolol

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. Steven Gabardi

Brigham and Women's Hospital

Phone: 617-732-7658

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place