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This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with stage 1 or stage 2 hypertension after the withdrawal of active medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration |
|
| 2 | Placebo Comparator | Matching placebo tablets, oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebivolol | Drug | Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Sitting Diastolic Blood Pressure | Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough. | From baseline, week 0 (Visit 9) to week 4 (Visit 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Sitting Systolic Blood Pressure | Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral systolic blood pressure measured at drug trough. | From baseline, week 0 (Visit 9) to week 4 (Visit 12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tatjana Lukic, MD, MSc | Forest Research Institute, a Subsidiary of Forest Laboratories Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site | Chandler | Arizona | 85225 | United States | ||
| Forest Investigative Site |
Patients went through a 4-5 week, single blind, placebo run-in/washout phase, followed by a 12 week single-blind active treatment phase with nebivolol before randomization
The recruitment period was five months, from November 2008 through March 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nebivolol | Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo | Drug | Matching placebo tablets, oral administration |
|
| Phoenix |
| Arizona |
| 85050 |
| United States |
| Forest Investigative Site | Los Angeles | California | 90057 | United States |
| Forest Investigative Site | Bradenton | Florida | 34203 | United States |
| Forest Investigative Site | Brooksville | Florida | 34613 | United States |
| Forest Investigative Site | DeLand | Florida | 32720 | United States |
| Forest Investigative Site | Hollywood | Florida | 33021 | United States |
| Forest Investigative Site | Miami | Florida | 33014 | United States |
| Forest Investigative Site | Miami | Florida | 33156 | United States |
| Forest Investigative Site | Miami | Florida | 33169 | United States |
| Forest Investigative Site | Pembroke Pines | Florida | 33024 | United States |
| Forest Investigative Site | St. Petersburg | Florida | 33709 | United States |
| Forest Investigative Site | Auburn | Maine | 04210 | United States |
| Forest Investigative Site | Cary | North Carolina | 27518 | United States |
| Forest Investigative Site | Hickory | North Carolina | 28601 | United States |
| Forest Investigative Site | Salisbury | North Carolina | 28144 | United States |
| Forest Investigative Site | Wilmington | North Carolina | 28401 | United States |
| Forest Investigative Site | Winston-Salem | North Carolina | 27103 | United States |
| Forest Investigative Site | Cincinnati | Ohio | 45242 | United States |
| Forest Investigative Site | Marion | Ohio | 43302 | United States |
| Forest Investigative Site | Lancaster | Pennsylvania | 17601 | United States |
| Forest Investigative Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Forest Investigative Site | Simpsonville | South Carolina | 29681 | United States |
| Forest Investigative Site | New Tazewell | Tennessee | 37825 | United States |
| Forest Investigative Site | Dallas | Texas | 75231 | United States |
| Forest Investigative Site | Dallas | Texas | 75234 | United States |
Matching placebo tablets, oral administration |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nebivolol | Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration |
| BG001 | Placebo | Matching placebo tablets, oral administration |
| 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 | Number | participants |
| |||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Trough Sitting Diastolic Blood Pressure | Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough. | Posted | Mean | Standard Deviation | mm HG | From baseline, week 0 (Visit 9) to week 4 (Visit 12) |
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| Secondary | Trough Sitting Systolic Blood Pressure | Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral systolic blood pressure measured at drug trough. | Posted | Mean | Standard Deviation | mm HG | From baseline, week 0 (Visit 9) to week 4 (Visit 12) |
|
|
Adverse event data was collected for a period of 9 months, from November 2008 to August 2009.
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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 | Single-blind Nebivolol | Pre-randomization 12 week nebivolol treatment. | 2 | 269 | 29 | 269 | ||
| EG001 | Nebivolol | Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration | 0 | 102 | 0 | 102 | ||
| EG002 | Placebo | Matching placebo tablets, oral administration | 0 | 105 | 0 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedRDA 11.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
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 | |
|---|---|---|---|---|
| John Whalen, MD Executive Director of Clinical Development - Cardiovascular and Metabolism | Forest Laboratories | 1-201-427-8259 | John.Whalen@frx.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068577 | Nebivolol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| 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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| Title | Measurements |
|---|---|
|
| >=65 years |
|
| Male |
|
|