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The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebivolol | Drug | 5 mg, titrated to 20 mg, once daily oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy | Office blood pressure measured at trough by automatic oscillometric device. | Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6) |
| Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy | Office blood pressure measured at trough by automatic oscillometric device. | Change from Baseline (Week 0) to Visit 4 (Week 6) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manfred Stapff, MD, PhD | Forest Research Institute, a Subsidiary of Forest Laboratories Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 008 | Foley | Alabama | 36535 | United States | ||
| Forest Investigative Site 021 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23332366 | Derived | Lewin A, Punzi H, Luo X, Stapff M. Nebivolol monotherapy for patients with systolic stage II hypertension: results of a randomized, placebo-controlled trial. Clin Ther. 2013 Feb;35(2):142-52. doi: 10.1016/j.clinthera.2012.12.015. Epub 2013 Jan 15. |
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A 4 week single-blind placebo washout phase was required for patients on anti-hypertensives at screening.
Recruitment occured from March 2010 through October 2010 at 36 US sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nebivolol | 5 mg, titrated to 20 mg, once daily oral administration |
| FG001 | Placebo | Dose-matched placebo, once daily oral administration |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | 5 mg or 20 mg once daily, oral administration |
|
| Montgomery |
| Alabama |
| 36117 |
| United States |
| Forest Investigative Site 006 | Chino | California | 91710 | United States |
| Forest Investigative Site 002 | Long Beach | California | 90806 | United States |
| Forest Investigative Site 004 | Los Angeles | California | 90057 | United States |
| Forest Investigative Site 020 | Temecula | California | 92591 | United States |
| Forest Investigative Site 028 | Coral Gables | Florida | 33134 | United States |
| Forest Investigative Site 014 | Daytona Beach | Florida | 32114 | United States |
| Forest Investigative Site 001 | Fort Lauderdale | Florida | 33308 | United States |
| Forest Investigative Site 037 | Fort Lauderdale | Florida | 33316 | United States |
| Forest Investigative Site 033 | Hialeah | Florida | 33012 | United States |
| Forest Investigative Site 026 | Jacksonville | Florida | 32216 | United States |
| Forest Investigative Site 017 | Miami | Florida | 33133 | United States |
| Forest Investigative Site 010 | Miami | Florida | 33169 | United States |
| Forest Investigative Site 030 | Orlando | Florida | 32806 | United States |
| Forest Investigative Site 009 | Atlanta | Georgia | 30338 | United States |
| Forest Investigative Site 031 | Augusta | Georgia | 30904 | United States |
| Forest Investigative Site 039 | Meridian | Idaho | 83646 | United States |
| Forest Investigative Site 007 | Auburn | Maine | 04210 | United States |
| Forest Investigative Site 038 | Baltimore | Maryland | 21204 | United States |
| Forest Investigative Site 011 | Baltimore | Maryland | 21209 | United States |
| Forest Investigative Site 029 | Prince Frederick | Maryland | 20678 | United States |
| Forest Investigative Site 023 | Paw Paw | Michigan | 49079 | United States |
| Forest Investigative Site 005 | Florissant | Missouri | 63033 | United States |
| Forest Investigative Site 041 | Las Vegas | Nevada | 89106 | United States |
| Forest Investigative Site 040 | New York | New York | 10010 | United States |
| Forest Investigative Site 012 | Hickory | North Carolina | 28601 | United States |
| Forest Investigative Site 027 | Salisbury | North Carolina | 28144 | United States |
| Forest Investigative Site 024 | Harleysville | Pennsylvania | 19438 | United States |
| Forest Investigative Site 013 | Charleston | South Carolina | 29407 | United States |
| Forest Investigative Site 035 | Greenville | South Carolina | 29605 | United States |
| Forest Investigative Site 018 | Mt. Pleasant | South Carolina | 29464 | United States |
| Forest Investigative Site 022 | Simpsonville | South Carolina | 29681 | United States |
| Forest Investigative Site 003 | Memphis | Tennessee | 38119 | United States |
| Forest Investigative Site 032 | Corpus Christi | Texas | 78404 | United States |
| Forest Investigative Site 025 | Richmond | Virginia | 23219 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nebivolol | 5 mg, titrated to 20 mg, once daily oral administration |
| BG001 | Placebo | Dose-matched placebo, once daily 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 | Count of Participants | 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 | Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy | Office blood pressure measured at trough by automatic oscillometric device. | Posted | Mean | Standard Deviation | mm Hg | Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6) |
|
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| |||||||||||||||||||||||||||||
| Primary | Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy | Office blood pressure measured at trough by automatic oscillometric device. | Posted | Mean | Standard Deviation | mm Hg | Change from Baseline (Week 0) to Visit 4 (Week 6) |
|
|
Adverse event data was collected for a period of 10 months, from March 2010 to January 2011.
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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 | 5 mg, titrated to 20 mg, once daily oral administration | 1 | 290 | 0 | 290 | ||
| EG001 | Placebo | Dose-matched placebo, once daily oral administration | 3 | 142 | 0 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myofascial pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
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All data generated in this study will be the property of Forest Research Institute, Inc. 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, Inc.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manfred Stapff, MD, PhD | Forest Research Institute | 201-427-8000 | 8686 | manfred.stapff@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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| >=65 years |
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| Male |
|
|