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| Name | Class |
|---|---|
| Mylan Laboratories | INDUSTRY |
The purpose of this study was to compare the tolerability of nebivolol to metoprolol ER in a general population of patients with mild to moderate hypertension receiving hydrochlorothiazide (HCTZ)
This study was an 18-week study to evaluate the tolerability of nebivolol compared to metoprolol ER in outpatients with mild to moderate hypertension taking HCTZ. It is a multi-center, randomized, double blind (DB), active-control, parallel-group study, starting with a 4-week HCTZ run-in phase, followed by a 12-week DB treatment phase. Patients meeting the entry criteria at the end of run-in are randomized to one of two treatment groups, nebivolol or metoprolol ER. Up-titration of dose of study drug will occur if needed during the first 4 weeks of the DB phase, after which there is an 8-week stable-dose period of treatment. A 2-week double-blind withdrawal phase follows, during which tapering off study drug occurs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebivolol | Experimental | Nebivolol 5 mg, 10 mg or 20 mg |
|
| Metoprolol ER | Active Comparator | Metoprolol ER 50 mg, 100 mg or 200 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoprolol ER | Drug | Metoprolol ER once daily, oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score | The PSQ contained 44 possible symptoms rated from 0 (no discomfort) to 5 (extreme discomfort). | Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral Blood Pressure (BP) | Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14) | |
| Pulse Rate | Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Research Institute 014 | Birmingham | Alabama | 35205 | United States | ||
| Forest Research Institute 028 |
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| Label | URL |
|---|---|
| Related Info | View source |
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All patients went through a 4 week hydrochlorothiazide (HCTZ) run-in phase before randomization.
Patient recruitment occurred over a four month period from October 2007 to January 2008 at 39 US sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nebivolol | Nebivolol 5 mg, 10 mg or 20 mg |
| FG001 | Metoprolol Extended-Release (ER) | Metoprolol ER 50 mg, 100 mg or 200 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Nebivolol |
| Drug |
Nebivolol once daily, oral administration |
|
| Beverly Hills |
| California |
| 90211 |
| United States |
| Forest Research Institute 054 | Encinitas | California | 92024 | United States |
| Forest Research Institute 025 | Roseville | California | 95661 | United States |
| Forest Research Institute 013 | Tustin | California | 92780 | United States |
| Forest Research Institute 053 | Vista | California | 92083 | United States |
| Forest Research Institute 052 | Walnut Creek | California | 94598 | United States |
| Forest Research Institute 033 | Westlake Village | California | 91361 | United States |
| Forest Research Institute 010 | DeLand | Florida | 32720 | United States |
| Forest Research Institute 019 | Holly Hill | Florida | 32117 | United States |
| Forest Research Institute 036 | Hollywood | Florida | 33023 | United States |
| Forest Research Institute 007 | Pembroke Pines | Florida | 33024 | United States |
| Forest Research Institute 009 | Atlanta | Georgia | 30338 | United States |
| Forest Research Institute 006 | Oxon Hill | Maryland | 20745 | United States |
| Forest Research Institute 027 | Las Vegas | Nevada | 89106 | United States |
| Forest Research Institute 050 | Salisbury | North Carolina | 28144 | United States |
| Forest Research Institute 039 | Wilmington | North Carolina | 28401 | United States |
| Forest Investigative Site 002 | Charleston | South Carolina | 29407 | United States |
| Forest Research Institute 032 | Greenville | South Carolina | 29615 | United States |
| Forest Research Institute 008 | Nashville | Tennessee | 37203 | United States |
| Forest Research Institute 003 | Carrollton | Texas | 75006 | United States |
| Forest Research Institute 012 | San Antonio | Texas | 78229 | United States |
| Forest Research Institute 048 | Sugar Land | Texas | 77479 | United States |
| Forest Research Institute 040 | Bountiful | Utah | 84010 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nebivolol | Nebivolol 5 mg, 10 mg or 20 mg |
| BG001 | Metoprolol Extended-Release (ER) | Metoprolol ER 50 mg, 100 mg or 200 mg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| 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 From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score | The PSQ contained 44 possible symptoms rated from 0 (no discomfort) to 5 (extreme discomfort). | Formal analysis of the primary endpoint was not conducted in this abbreviated study as the study was terminated before visit 10 was reached. | Posted | Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12) |
|
| ||||||||||||||||||||||
| Secondary | Peripheral Blood Pressure (BP) | Formal analysis of the secondary endpoint was not conducted in this abbreviated study as the study was terminated before all visits were completed. No patients completed the study. | Posted | Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14) |
|
| |||||||||||||||||||||||
| Secondary | Pulse Rate | Formal analysis of the secondary endpoint was not conducted in this abbreviated study as the study was terminated before all visits were completed. No patients completed the study. | Posted | Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14) |
|
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Adverse Event data was collected over a four month period from October 2007 to January 2008.
Non-serious adverse events based on the safety population of (n=49).
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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 | Nebivolol | Nebivolol 5 mg, 10 mg or 20 mg | 0 | 25 | 0 | 25 | 5 | 25 |
| EG001 | Metoprolol Extended-Release (ER) | Metoprolol ER 50 mg, 100 mg or 200 mg | 0 | 26 | 0 | 26 | 3 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
Study was terminated early due to administrative reasons. Formal analyses of primary and secondary endpoints were not conducted in this study.
Sponsor can review results communications prior to public release & can embargo communications re: results for 60 days from time submitted to sponsor for review. PI shall not disclose sponsor's confidential information. Upon sponsor's request, PI shall delete any proprietary info & shall not include raw data in the publication. On sponsor's request, PI shall delay submission for any pub while sponsor files patent applications. Any publication will give recognition to Sponsor's support.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008790 | Metoprolol |
| D000068577 | Nebivolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| >=65 years |
|
| Male |
|