Trial Outcomes & Findings for The Blood Pressure and Metabolic Effects of Nebivolol in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose (NCT NCT00673790)
NCT ID: NCT00673790
Last Updated: 2020-02-26
Results Overview
Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
537 participants
Primary outcome timeframe
Change from Baseline Visit 4 (Week 0) To Visit 8 (Week 12)
Results posted on
2020-02-26
Participant Flow
May 2008 to March 2010 at 96 US sites, 72 sites randomized patients.
A losartan or lisinopril run-in phase was required for all patients before assignment to Placebo or Nebivolol or Hydrochlorothiazide arms.
Participant milestones
| Measure |
Nebivolol
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration
|
Hydrochlorothiazide (HCTZ)
Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
|
Placebo
Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
|
|---|---|---|---|
|
Overall Study
STARTED
|
223
|
212
|
102
|
|
Overall Study
COMPLETED
|
178
|
174
|
90
|
|
Overall Study
NOT COMPLETED
|
45
|
38
|
12
|
Reasons for withdrawal
| Measure |
Nebivolol
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration
|
Hydrochlorothiazide (HCTZ)
Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
|
Placebo
Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
23
|
14
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
2
|
|
Overall Study
Protocol Violation
|
6
|
9
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
6
|
5
|
|
Overall Study
Sponsor Terminated due to PI oversight
|
0
|
1
|
0
|
|
Overall Study
Poor compliance
|
1
|
0
|
0
|
|
Overall Study
Participated in two Nebivolol studies
|
0
|
0
|
1
|
|
Overall Study
Unconfirmed pregnancy
|
0
|
1
|
0
|
|
Overall Study
Randomization criteria not met
|
0
|
1
|
0
|
Baseline Characteristics
The Blood Pressure and Metabolic Effects of Nebivolol in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose
Baseline characteristics by cohort
| Measure |
Nebivolol
n=223 Participants
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration
|
Hydrochlorothiazide (HCTZ)
n=212 Participants
Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
|
Placebo
n=102 Participants
Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
|
Total
n=537 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
55.2 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Age, Customized
Patients 18 to 65 years of age
|
190 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
443 Participants
n=4 Participants
|
|
Age, Customized
Patients greater than or equal to 65 years of age.
|
33 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
236 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
301 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
223 Participants
n=5 Participants
|
212 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
537 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline Visit 4 (Week 0) To Visit 8 (Week 12)Population: The between-treatment-group comparison was performed by means of an analysis-of-covariance model with treatment group and study center as factors and baseline value as a covariate based on Intent-to-Treat (ITT) population. As pre-specified in the protocol, the change in seated DBP was performed between the nebivolol and placebo group.
Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).
Outcome measures
| Measure |
Nebivolol
n=217 Participants
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration
|
Placebo
n=100 Participants
Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
|
Placebo
Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
|
|---|---|---|---|
|
Trough Seated Diastolic Blood Pressure
|
-9.4 mm Hg
Standard Deviation 8.9
|
-5.0 mm Hg
Standard Deviation 9.5
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline Visit 3 or 4 (Week -2 or 0) To Visit 8 (Week 12)Population: The between-treatment-group comparison was performed by means of an analysis-of-covariance model with treatment group and study center as factors and baseline value as a covariate based on Intent-to-Treat (ITT) population.
Change from Baseline in Plasma Glucose 2 Hours Post-oral Glucose 75 grams, given as part of an Oral Glucose Tolerance Test (OGTT). Last Observation Carried Forward.
Outcome measures
| Measure |
Nebivolol
n=217 Participants
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration
|
Placebo
n=209 Participants
Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
|
Placebo
n=100 Participants
Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
|
|---|---|---|---|
|
Plasma Glucose Level After an Oral Glucose Tolerance Test
|
0.20 g/mL
Standard Error 0.190
|
0.31 g/mL
Standard Error 0.184
|
-0.21 g/mL
Standard Error 0.247
|
Adverse Events
Nebivolol
Serious events: 5 serious events
Other events: 35 other events
Deaths: 0 deaths
Hydrochlorothiazide (HCTZ)
Serious events: 6 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nebivolol
n=223 participants at risk
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration
|
Hydrochlorothiazide (HCTZ)
n=212 participants at risk
Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
|
Placebo
n=102 participants at risk
Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
|
|---|---|---|---|
|
Nervous system disorders
Basal ganglia haemorrage
|
0.45%
1/223
|
0.00%
0/212
|
0.00%
0/102
|
|
General disorders
Non-cardiac chest pain
|
0.45%
1/223
|
0.00%
0/212
|
0.00%
0/102
|
|
Cardiac disorders
Cardiac failure congestive
|
0.45%
1/223
|
0.00%
0/212
|
0.00%
0/102
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.45%
1/223
|
0.00%
0/212
|
0.00%
0/102
|
|
Infections and infestations
Pneumonia
|
0.45%
1/223
|
0.00%
0/212
|
0.00%
0/102
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/223
|
0.47%
1/212
|
0.00%
0/102
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/223
|
0.47%
1/212
|
0.00%
0/102
|
|
General disorders
Chest pain
|
0.00%
0/223
|
0.47%
1/212
|
0.00%
0/102
|
|
Psychiatric disorders
Depression
|
0.00%
0/223
|
0.47%
1/212
|
0.00%
0/102
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/223
|
0.00%
0/212
|
0.98%
1/102
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/223
|
0.00%
0/212
|
0.98%
1/102
|
|
Nervous system disorders
Migraine
|
0.00%
0/223
|
0.00%
0/212
|
0.98%
1/102
|
|
Cardiac disorders
Myocardial infaction
|
0.00%
0/223
|
0.94%
2/212
|
0.00%
0/102
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/223
|
0.47%
1/212
|
0.00%
0/102
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/223
|
0.47%
1/212
|
0.00%
0/102
|
Other adverse events
| Measure |
Nebivolol
n=223 participants at risk
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration
|
Hydrochlorothiazide (HCTZ)
n=212 participants at risk
Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
|
Placebo
n=102 participants at risk
Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
|
|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
5.4%
12/223
|
0.00%
0/212
|
0.00%
0/102
|
|
Nervous system disorders
Headache
|
5.4%
12/223
|
5.7%
12/212
|
6.9%
7/102
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
12/223
|
4.7%
10/212
|
6.9%
7/102
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All data generated in this study will be the property of Forest Research Institute. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute.
- Publication restrictions are in place
Restriction type: OTHER