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Trial record 1 of 1 for:    9453022 [PUBMED-IDS]
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Nebivolol Effect on Nitric Oxide Levels, Blood Pressure, and Renal Function in Kidney Transplant Patients

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ClinicalTrials.gov Identifier: NCT01157234
Recruitment Status : Completed
First Posted : July 5, 2010
Results First Posted : March 24, 2016
Last Update Posted : March 24, 2016
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Nebivolol
Drug: Metoprolol
Enrollment 32
Recruitment Details

The trial was conducted at the University of Florida and Shands Renal Transplant Clinic.

The first patient was randomized on July 8, 2010 and the follow up of the last patient ended on July 21, 2014.

Pre-assignment Details 32 participants were screened, 2 failed screening and 30 met the eligibility criteria and randomized to either the arm with nebivolol or the arm with metoprolol.
Arm/Group Title Nebivolol Metoprolol
Hide Arm/Group Description Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study. Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Period Title: Overall Study
Started 15 15
Completed 14 15
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Nebivolol Metoprolol Total
Hide Arm/Group Description Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study. Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study. Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
Full analysis set included all participants who signed informed consent and received at least one dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
53  (15.9) 46.4  (13.8) 49.7  (14.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
5
  33.3%
4
  26.7%
9
  30.0%
Male
10
  66.7%
11
  73.3%
21
  70.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  53.3%
5
  33.3%
13
  43.3%
White
7
  46.7%
10
  66.7%
17
  56.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
Plasma Nitric Oxide   [1] 
Mean (Standard Deviation)
Unit of measure:  Nmol/l
Number Analyzed 15 participants 15 participants 30 participants
52.93  (21.09) 48.23  (15.37) 50.53  (17.99)
[1]
Measure Description: Full analysis included all participants who signed informed consent and received at least one dose of study drug.
Estimated Glomerular Filtration Rate   [1] 
Mean (Standard Deviation)
Unit of measure:  Milliliter/minute
Number Analyzed 15 participants 15 participants 30 participants
53.13  (14.15) 54.47  (14.65) 53.80  (13.67)
[1]
Measure Description:

Estimated glomerular filtration rate is calculated according to the modification of diet in renal disease equation using age, gender and race in calculating kidney function.

Full analysis included all participants who signed informed consent and received at least one dose of study drug

Systolic Blood Pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  Millimeter, mercury
Number Analyzed 15 participants 15 participants 30 participants
132.93  (15.79) 131.33  (18.14) 132.13  (16.73)
[1]
Measure Description: Full analysis included all participants who signed informed consent and received at least one dose of study drug.
Diastolic Blood Pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  Millimeter, mercury
Number Analyzed 15 participants 15 participants 30 participants
84.07  (8.59) 86.33  (8.62) 85.20  (8.53)
[1]
Measure Description: Full analysis included all participants who signed informed consent and received at least one dose of study drug
Mean Arterial Blood Pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  Millimeter, mercury
Number Analyzed 15 participants 15 participants 30 participants
100.20  (8.06) 101.47  (10.76) 100.83  (9.36)
[1]
Measure Description: Full analysis included all participants who signed informed consent and received at least one dose of study drug
Number of Antihypertensive Drug Classes Being Used   [1] 
Mean (Standard Deviation)
Unit of measure:  Antihypertensive Drug Classes
Number Analyzed 15 participants 15 participants 30 participants
2.00  (0.84) 1.80  (0.68) 1.90  (0.89)
[1]
Measure Description: Full analysis included all participants who signed informed consent and received at least one dose of study drug
1.Primary Outcome
Title Plasma Nitric Oxide Level Change From Baseline to Month 12 Between the Groups.
Hide Description Percent change in Nitric Oxide (NO) blood level (nmol/L)=[Month-12 NO blood level minus baseline NO blood level] divided by [baseline NO blood level] multiplied by 100, where all levels are in nmol/L.
Time Frame Change in Baseline, Month-12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who signed informed consent and received at least one dose of study drug.
Arm/Group Title Nebivolol Metoprolol
Hide Arm/Group Description:
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Overall Number of Participants Analyzed 15 15
Least Squares Mean (Standard Error)
Unit of Measure: percent change
11.47  (9.20) -17.27  (9.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol, Metoprolol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 28.73
Confidence Interval (2-Sided) 95.00%
1.93 to 55.53
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Estimated Glomerular Filtration Rate (ml/Minute) Change From Baseline to Month-12 Between the Groups
Hide Description The changed percentage in Estimated Glomerular Filtration Rate (eGFR), (based on the Modification of Diet in Renal Disease Equation)=[Month-12 GFR level minus baseline eGFR level] divided by [baseline eGFR level] multiplied by 100, where all levels are in ml/min.
Time Frame Change in Baseline, Month-12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who signed inform consent and received at least one dose of study drug.
Arm/Group Title Nebivolol Metoprolol
Hide Arm/Group Description:
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Overall Number of Participants Analyzed 15 15
Least Squares Mean (Standard Error)
Unit of Measure: percent change
2.16  (7.16) 10.43  (7.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol, Metoprolol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 8.27
Confidence Interval (2-Sided) 95%
-12.58 to 29.12
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Systolic Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 of Treatment Between the Groups
Hide Description Absolute change in Systolic Blood Pressure (SBP), (millimeter, Mercury)=Month-12 sitting trough SBP level minus baseline sitting trough SBP level
Time Frame Change in Baseline, Month-12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who signed inform consent and received at least one dose of study drug.
Arm/Group Title Nebivolol Metoprolol
Hide Arm/Group Description:
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Overall Number of Participants Analyzed 15 15
Least Squares Mean (Standard Error)
Unit of Measure: millimeter, Mercury
-2.65  (2.73) -3.88  (2.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol, Metoprolol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
-6.74 to 9.20
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.87
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Diastolic Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 Between the Groups
Hide Description Absolute Change in Diastolic Blood Pressure (DBP), (millimeter, Mercury)= Month-12 sitting trough Diastolic Blood Pressure (millimeter, Mercury) level minus baseline sitting trough Diastolic Blood Pressure (millimeter, Mercury).
Time Frame Change in Baseline, Month-12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who signed inform consent and received at least one dose of study drug.
Arm/Group Title Nebivolol Metoprolol
Hide Arm/Group Description:
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Overall Number of Participants Analyzed 15 15
Least Squares Mean (Standard Error)
Unit of Measure: millimeter, mercury
-0.66  (1.91) -2.35  (1.91)
5.Secondary Outcome
Title Mean Arterial Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 Between the Groups
Hide Description

Absolute change in Mean Arterial Blood Pressure, (MAP), (millimeter, Mercury= Month-12 sitting trough MAP minus baseline sitting trough MAP.

Mean Arterial Pressure= 2/3 trough diastolic blood pressure + 1/3 trough systolic blood pressure

Time Frame Change in Baseline, Month-12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who signed inform consent and received at least one dose of study drug.
Arm/Group Title Nebivolol Metoprolol
Hide Arm/Group Description:
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Overall Number of Participants Analyzed 15 15
Least Squares Mean (Standard Error)
Unit of Measure: millimeter, Mercury
-1.07  (2.11) -3.19  (2.11)
6.Secondary Outcome
Title Number of Antihypertensive Drug Classes Change From Baseline to Month-12 Between the Groups.
Hide Description Percent change in quantity of Anti-Hypertensive Drug Classes (AHDC)=[Month-12 absolute number of AHDC minus baseline absolute number of AHDC] divided by [baseline absolute number of AHDC] multiplied by 100.
Time Frame Change in Baseline, Month-12
Hide Outcome Measure Data
Hide Analysis Population Description
Percent change
Arm/Group Title Nebivolol Metoprolol
Hide Arm/Group Description:
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Overall Number of Participants Analyzed 15 15
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-8.14  (11.58) 8.70  (11.58)
7.Secondary Outcome
Title Plasma Asymmetric Dimethylarginine (ADMA) Change From Baseline to Month 12 Between the Groups
Hide Description Percent change in plasma ADMA (umol/L)=[month-12 plasma ADMA level minus baseline plasma ADMA level] divided by [baseline plasma ADMA level] multiplied by 100, where all levels are in umol/L.
Time Frame Baseline, Month-12
Hide Outcome Measure Data
Hide Analysis Population Description
Technical limitations constrained measurements of Asymmetric Dimethylarginine (ADMA), resulting in no analysis for this outcome.
Arm/Group Title Nebivolol Metoprolol
Hide Arm/Group Description:
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Plasma Arginine (ARG) Level Change From Baseline to Month-12 Between Groups
Hide Description Percent change in plasma Arginine (umol/L)=[month-12 plasma Arginine level minus baseline plasma Arginine level] divided by [baseline plasma Arginine level] multiplied by 100, where all levels are in umol/L
Time Frame Baseline, Month-12
Hide Outcome Measure Data
Hide Analysis Population Description
Technical limitations constrained measurements of plasma Arginine, resulting in no analysis for this outcome.
Arm/Group Title Nebivolol Metoprolol
Hide Arm/Group Description:
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Other Pre-specified Outcome
Title Plasma Nitric Oxide Level (Nmol/L) at Month-12 Between the Groups.
Hide Description [Not Specified]
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who signed inform consent and received at least one dose of study drug
Arm/Group Title Nebivolol Metoprolol
Hide Arm/Group Description:
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Overall Number of Participants Analyzed 15 15
Least Squares Mean (Standard Error)
Unit of Measure: nmol/L
50.07  (3.93) 38.13  (3.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol, Metoprolol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 11.94
Confidence Interval (2-Sided) 95.00%
0.48 to 23.40
Estimation Comments [Not Specified]
10.Post-Hoc Outcome
Title Percent Change in Plasma Nitric Oxide Level From Baseline to Month-12 of Treatment With Nebivolol in Transplant Recipients <50 Years Old Compared With Metoprolol in Transplant Recipients >/= 50 Years Old.
Hide Description [Not Specified]
Time Frame Baseline and Month-12
Hide Outcome Measure Data
Hide Analysis Population Description
Nebivolol and metoprolol groups were subdivided into <50 years old and >50 years old subgroups and differences between subgroups were analyzed.
Arm/Group Title Nebivolol <50 Year Old Metoprolol >/= 50 Year Old
Hide Arm/Group Description:
Hypertensive kidney transplant recipients less than 50 years of age treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study
Hypertensive kidney transplant recipients age 50 years or higher treated with Metoprolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study
Overall Number of Participants Analyzed 6 7
Least Squares Mean (Standard Error)
Unit of Measure: percent change
51.55  (14.55) -17.99  (13.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol <50 Year Old, Metoprolol >/= 50 Year Old
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 69.54
Confidence Interval (2-Sided) 99.7%
12.71 to 126.37
Parameter Dispersion
Type: Standard Error of the mean
Value: 19.83
Estimation Comments [Not Specified]
11.Post-Hoc Outcome
Title Percent Change in Plasma Nitric Oxide Level From Baseline to Month-12 of Treatment With Nebivolol in Transplant Recipients < 50 Years Old Compared With Metoprolol in Transplant Recipients < 50 Years Old
Hide Description [Not Specified]
Time Frame Change in Baseline, Month-12
Hide Outcome Measure Data
Hide Analysis Population Description
Nebivolol and metoprolol groups were subdivided into <50 years old and >50 years old subgroups and differences between subgroups were analyzed.
Arm/Group Title Nebivolol < 50 Years Old Metoprolol <50 Years Old
Hide Arm/Group Description:
Hypertensive kidney transplant recipients less than 50 years of age treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Hypertensive kidney transplant recipients less than 50 years of age treated with Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Overall Number of Participants Analyzed 6 8
Least Squares Mean (Standard Error)
Unit of Measure: percent change
51.55  (14.55) -16.64  (12.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol < 50 Years Old, Metoprolol <50 Years Old
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 68.19
Confidence Interval (2-Sided) 99.17%
13.02 to 123.36
Parameter Dispersion
Type: Standard Error of the mean
Value: 19.24
Estimation Comments [Not Specified]
12.Post-Hoc Outcome
Title Percent Change in Plasma Nitric Oxide Level From Baseline to Month-twelve of Treatment With Nebivolol in Transplant Recipients >/= 50 Years Old Compared With Nebivolol in Transplant Recipients < 50 Years Old.
Hide Description [Not Specified]
Time Frame Change in Baseline, Month-12
Hide Outcome Measure Data
Hide Analysis Population Description
Nebivolol and metoprolol groups were subdivided into <50 years old and >50 years old subgroups and differences between subgroups were analyzed.
Arm/Group Title Nebivolol >/=50 Years Old Metoprolol <50 Years Old
Hide Arm/Group Description:
Hypertensive kidney transplant recipients age 50 years or higher treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Hypertensive kidney transplant recipients age less than 50 years treated with Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Overall Number of Participants Analyzed 9 8
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-15.25  (11.88) -16.64  (12.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol >/=50 Years Old, Metoprolol <50 Years Old
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.39
Confidence Interval (2-Sided) 99.17%
-48.25 to 51.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 17.32
Estimation Comments [Not Specified]
13.Post-Hoc Outcome
Title Percent Change in Plasma Nitric Oxide Level From Baseline to Month-12 of Treatment With Nebivolol in Transplant Recipients >/= 50 Years Old Compared With Metoprolol in Transplant Recipients Age >/= 50 Years Old.
Hide Description [Not Specified]
Time Frame Change in Baseline, Month-12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol >/=50 Years Old Metoprolol >/=50 Years Old
Hide Arm/Group Description:
Hypertensive kidney transplant recipients age 50 years or higher treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Hypertensive kidney transplant recipients age 50 years or higher treated with Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
Overall Number of Participants Analyzed 9 7
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-15.25  (11.88) -17.99  (13.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol >/=50 Years Old, Metoprolol >/=50 Years Old
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 2.74
Confidence Interval (2-Sided) 99.17%
-48.74 to 54.22
Parameter Dispersion
Type: Standard Error of the mean
Value: 17.96
Estimation Comments [Not Specified]
Time Frame 4 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nebivolol Metoprolol
Hide Arm/Group Description

Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.

Nebivolol: Nebivolol 5 mg once daily, titrated to a maximum total daily dose of 40 mg to achieve a blood pressure of < 140/ 90.

Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.

Metoprolol: Metoprolol 25 mg twice daily, titrated to a maximum total daily dose of 400 mg to achieve a blood pressure < 140/90.

All-Cause Mortality
Nebivolol Metoprolol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Nebivolol Metoprolol
Affected / at Risk (%) Affected / at Risk (%)
Total   4/15 (26.67%)   5/15 (33.33%) 
Gastrointestinal disorders     
Vomiting   0/15 (0.00%)  1/15 (6.67%) 
Infections and infestations     
Urinary Tract Infection   1/15 (6.67%)  0/15 (0.00%) 
Cytomegalovirus Infection   0/15 (0.00%)  1/15 (6.67%) 
Injury, poisoning and procedural complications     
Abdominal Hematoma   1/15 (6.67%)  0/15 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate Cancer   0/15 (0.00%)  1/15 (6.67%) 
Renal and urinary disorders     
Renal Insufficiency   2/15 (13.33%)  1/15 (6.67%) 
Surgical and medical procedures     
Herniorraphy   0/15 (0.00%)  1/15 (6.67%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nebivolol Metoprolol
Affected / at Risk (%) Affected / at Risk (%)
Total   9/15 (60.00%)   13/15 (86.67%) 
Blood and lymphatic system disorders     
leukopenia   0/15 (0.00%)  1/15 (6.67%) 
Ear and labyrinth disorders     
Earache   1/15 (6.67%)  0/15 (0.00%) 
Endocrine disorders     
hyperglycemia   2/15 (13.33%)  3/15 (20.00%) 
Eye disorders     
Eye Irritation   1/15 (6.67%)  0/15 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain   1/15 (6.67%)  1/15 (6.67%) 
Constipation   1/15 (6.67%)  0/15 (0.00%) 
Diarrhea   4/15 (26.67%)  2/15 (13.33%) 
Dyspepsia   0/15 (0.00%)  1/15 (6.67%) 
Nausea   2/15 (13.33%)  1/15 (6.67%) 
Vomiting   2/15 (13.33%)  0/15 (0.00%) 
General disorders     
Chest Pain   1/15 (6.67%)  1/15 (6.67%) 
Edema   1/15 (6.67%)  1/15 (6.67%) 
Fatigue   1/15 (6.67%)  0/15 (0.00%) 
Influenza-like Illness   1/15 (6.67%)  0/15 (0.00%) 
Infections and infestations     
Cytomegalovirus Infection   1/15 (6.67%)  0/15 (0.00%) 
Urinary Tract Infection   2/15 (13.33%)  3/15 (20.00%) 
Musculoskeletal and connective tissue disorders     
Arm Pain   1/15 (6.67%)  0/15 (0.00%) 
Low Back Pain   1/15 (6.67%)  0/15 (0.00%) 
Nervous system disorders     
Dizziness   0/15 (0.00%)  1/15 (6.67%) 
Headache   2/15 (13.33%)  2/15 (13.33%) 
Psychiatric disorders     
Anxiety   0/15 (0.00%)  1/15 (6.67%) 
Reproductive system and breast disorders     
Hydrocele   0/15 (0.00%)  1/15 (6.67%) 
Respiratory, thoracic and mediastinal disorders     
Cough   4/15 (26.67%)  2/15 (13.33%) 
Dyspnea   1/15 (6.67%)  0/15 (0.00%) 
Nasal Congestion   3/15 (20.00%)  3/15 (20.00%) 
Oropharyngeal Pain   0/15 (0.00%)  1/15 (6.67%) 
Indicates events were collected by systematic assessment

Small numbers of subjects analyzed in a single center limits precision and generalizability of results.

Technical limitations prevented measurements of asymmetric dimethyl-arginine and arginine leading to absence of analysis for these outcomes.

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Alfonso H. Santos Jr, M,D,
Organization: University of Florida
Phone: 352-273-6374
Publications:
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01157234     History of Changes
Other Study ID Numbers: BYS-MD-42
First Submitted: July 2, 2010
First Posted: July 5, 2010
Results First Submitted: January 25, 2016
Results First Posted: March 24, 2016
Last Update Posted: March 24, 2016