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The purpose of this study is to evaluate long-term safety,tolerability and blood pressure effects of metoprolol versus nebivolol in patients with hypertension. These drugs may be given alone or in combination with other drugs that are commonly used in the treatment of hypertension
Approximately 50 million Americans have hypertension defined as a systolic blood pressure (SBP) greater then or equal to 140 mmHg and/or a diastolic blood pressure (DBP) greater then or equal to 90 mmHg. To control blood pressure, more than 2 agents are required in many patients. The current study is a randomized, titration-to-effect, open-label, multi center study. Patients will be randomized to either nebivolol or metoprolol. The dose of the randomized treatment can be titrated as needed to achieve blood pressure control. If necessary, additional antihypertensive agents (calcium antagonist, diuretic, etc.) can be added to achieve control. Patients will be seen every 1-3 months for approximately 18 months to assess long-term safety, tolerability and effectiveness of nebivolol versus metoprolol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-NEB | Experimental | Nebivolol |
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| 2-MET | Active Comparator | Metoprolol |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebivolol (NEB) | Drug | Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Sitting Diastolic Blood Pressure (DBP) Taken at Trough at the End of Treatment Compared to Baseline | The primary efficacy parameter was the change in the average trough sitting DBP at the end of treatment (Visit 10 or Early Termination) compared with baseline (baseline was defined as the baseline visit in Study NEB 310 [NCT00145210]). | Through study duration (approximately 18 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Trough Sitting Diastolic Blood Pressure (DBP) at Each Study Visit (Visits 1 Through 9) Compared to Baseline | Data for the analysis of the change from baseline in mean trough sitting DBP at each study visit (Visits 1 through 9) compared with baseline (baseline was defined as the baseline visit in Study NEB 310 [NCT00145210]) by treatment group are provided below. | Through study completion (approximately 18 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Betty S Riggs, MD, MBA | Mylan Pharmaceuticals Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mylan Pharmaceuticals Inc. | Morgantown | West Virginia | 26505 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1-NEB | Nebivolol Nebivolol: Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks. |
| FG001 | 2-MET | Metoprolol Metoprolol: Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1-NEB | Nebivolol Nebivolol: Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks. |
| BG001 | 2-MET | Metoprolol Metoprolol: Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Average Sitting Diastolic Blood Pressure (DBP) Taken at Trough at the End of Treatment Compared to Baseline | The primary efficacy parameter was the change in the average trough sitting DBP at the end of treatment (Visit 10 or Early Termination) compared with baseline (baseline was defined as the baseline visit in Study NEB 310 [NCT00145210]). | Posted | Mean | Standard Deviation | mm Hg | Through study duration (approximately 18 months) |
|
Through study completion (approximately 18 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1-NEB | Nebivolol Nebivolol: Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA 7.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HEADACHE | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M. Rachel Kirker, PhD, Director, Clinical Oversight & Inspection Readiness | Viatris Inc | 724-485-6170 | rachel.kirker@viatris.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068577 | Nebivolol |
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Metoprolol (MET) | Drug | Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks. |
|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Summary of Participants that experienced one or more TEAEs by Treatment Group-Safety Population | Through study completion (approximately 18 months) |
| Lost to Follow-up |
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| Adverse Event |
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| Protocol Violation |
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| Treatment Failure |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Secondary | Change From Baseline in Mean Trough Sitting Diastolic Blood Pressure (DBP) at Each Study Visit (Visits 1 Through 9) Compared to Baseline | Data for the analysis of the change from baseline in mean trough sitting DBP at each study visit (Visits 1 through 9) compared with baseline (baseline was defined as the baseline visit in Study NEB 310 [NCT00145210]) by treatment group are provided below. | The overall number of participants analyzed equals the number of randomized patients at study start; the numbers analyzed at each visit equal the number of patients at each treatment visit. | Posted | Mean | Standard Deviation | mm Hg | Through study completion (approximately 18 months) |
|
|
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Summary of Participants that experienced one or more TEAEs by Treatment Group-Safety Population | Posted | Count of Participants | Participants | Through study completion (approximately 18 months) |
|
|
|
| 3 |
| 252 |
| 11 |
| 252 |
| 74 |
| 252 |
| EG001 | 2-MET | Metoprolol Metoprolol: Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks. | 0 | 84 | 2 | 84 | 28 | 84 |
| CHEST PAIN | General disorders | MedDRA 7.1 | Systematic Assessment |
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| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 7.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 7.1 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
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| ANIMAL BITE | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
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| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
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| WOUND | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
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| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 7.1 | Systematic Assessment |
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| LUMBAR SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
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| SPINAL OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
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| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
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| CEREBRAL ARTERY OCCLUSION | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
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| CERVICAL MYELOPATHY | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
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| ALCOHOLISM | Psychiatric disorders | MedDRA 7.1 | Systematic Assessment |
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| CONVERSION DISORDER | Psychiatric disorders | MedDRA 7.1 | Systematic Assessment |
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| PROSTATITIS | Reproductive system and breast disorders | MedDRA 7.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
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| Peripheral edema | General disorders | MedDRA 7.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
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Investigator Study Agreement: Publication Clause - Details of the Study and its results shall not be publicized or published in any form without prior consent of Covance and the Sponsor, Mylan.
| D000588 |
| Amines |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D020005 | Propanols |
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| Visit 5 |
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| Visit 6 |
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| Visit 7 |
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| Visit 9 |
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