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The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration |
|
| 2 | Placebo Comparator | Dose-matched placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebivolol | Drug | Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Seated Diastolic Blood Pressure (DBP) | Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach. | Change from Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Seated Systolic Blood Pressure (SBP) | Change from baseline in mean seated trough cuff Systolic Blood Pressure (SBP) at Week 8 as measured by an Omron device. The secondary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach. | Change from Baseline to Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tatjana Lukic, MD, M. Sc. | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 065 | Phoenix | Arizona | 85014 | United States | ||
| Forest Investigative Site 067 |
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Patient recruitment occurred over a 4 month period from August 2011 to December 2011 at 76 study sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Dose-matched placebo |
| FG001 | Nebivolol | Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
Dose-match placebo |
|
| Phoenix |
| Arizona |
| 85014 |
| United States |
| Forest Investigative Site 070 | Phoenix | Arizona | 85014 | United States |
| Forest Investigative Site 049 | Buena Park | California | 90620 | United States |
| Forest Investigative Site 034 | Burbank | California | 91505 | United States |
| Forest Investigative Site 039 | Costa Mesa | California | 92626 | United States |
| Forest Investigative Site 024 | Fountain Valley | California | 92708 | United States |
| Forest Investigative Site 020 | Fresno | California | 93726 | United States |
| Forest Investigative Site 021 | Fresno | California | 93726 | United States |
| Forest Investigative Site 040 | Greenbrae | California | 94904 | United States |
| Forest Investigative Site 047 | La Mesa | California | 91942 | United States |
| Forest Investigative Site 073 | Los Angeles | California | 90057 | United States |
| Forest Investigative Site 077 | Roseville | California | 95661 | United States |
| Forest Investigative Site 060 | San Bernardino | California | 92404 | United States |
| Forest Investigative Site 054 | San Francisco | California | 94115 | United States |
| Forest Investigative Site 018 | Spring Valley | California | 91978 | United States |
| Forest Investigative Site 028 | Denver | Colorado | 80220 | United States |
| Forest Investigative Site 059 | Brooksville | Florida | 34601 | United States |
| Forest Investigative Site 033 | Fort Lauderdale | Florida | 33306 | United States |
| Forest Investigative Site 006 | Hallandale | Florida | 33009 | United States |
| Forest Investigative Site 044 | Longwood | Florida | 32779 | United States |
| Forest Investigative Site 001 | Miami | Florida | 33014 | United States |
| Forest Investigative Site 012 | Miami | Florida | 33014 | United States |
| Forest Investigative Site 032 | Miami | Florida | 33014 | United States |
| Forest Investigative Site 055 | Miami | Florida | 33014 | United States |
| Forest Investigative Site 045 | Oviedo | Florida | 32765 | United States |
| Forest Investigative Site 031 | St. Petersburg | Florida | 33709 | United States |
| Forest Investigative Site 009 | Atlanta | Georgia | 30084 | United States |
| Forest Investigative Site 007 | Chicago | Illinois | 60611 | United States |
| Forest Investigative Site 004 | Morton | Illinois | 61550 | United States |
| Forest Investigative Site 072 | Evansville | Indiana | 47713 | United States |
| Forest Investigative Site 069 | Newburgh | Indiana | 47630 | United States |
| Forest Investigative Site 025 | Augusta | Kansas | 67010 | United States |
| Forest Investigative Site 029 | Louisville | Kentucky | 40213 | United States |
| Forest Investigative Site 068 | Madisonville | Kentucky | 42431 | United States |
| Forest Investigative Site 061 | Metairie | Louisiana | 70005 | United States |
| Forest Investigative Site 057 | New Orleans | Louisiana | 70119 | United States |
| Forest Investigative Site 058 | New Orleans | Louisiana | 70119 | United States |
| Forest Investigative Site 008 | Lutherville | Maryland | 21093 | United States |
| Forest Investigative Site 062 | Fall River | Massachusetts | 02702 | United States |
| Forest Investigative Site 075 | Paw Paw | Michigan | 49079 | United States |
| Forest Investigative Site 019 | Brooklyn Center | Minnesota | 55430 | United States |
| Forest Investigative Site 017 | Chaska | Minnesota | 55318 | United States |
| Forest Investigative Site 038 | Belzoni | Mississippi | 39038 | United States |
| Forest Investigative Site 035 | Olive Branch | Mississippi | 38654 | United States |
| Forest Investigative Site 023 | Las Vegas | Nevada | 89101 | United States |
| Forest Investigative Site 048 | Las Vegas | Nevada | 89101 | United States |
| Forest Investigative Site 052 | Las Vegas | Nevada | 89101 | United States |
| Forest Investigative Site 014 | Elizabeth | New Jersey | 27609 | United States |
| Forest Investigative Site 051 | Trenton | New Jersey | 08611 | United States |
| Forest Investigative Site 003 | Asheboro | North Carolina | 27203 | United States |
| Forest Investigative Site 010 | Charlotte | North Carolina | 28277 | United States |
| Forest Investigative Site 011 | Raleigh | North Carolina | 27609 | United States |
| Forest Investigative Site 016 | Raleigh | North Carolina | 27609 | United States |
| Forest Investigative Site 005 | Wilmington | North Carolina | 28401 | United States |
| Forest Investigative Site 036 | Winston-Salem | North Carolina | 27103 | United States |
| Forest Investigative Site 002 | Columbus | Ohio | 43213 | United States |
| Forest Investigative Site 050 | Norman | Oklahoma | 73069 | United States |
| Forest Investigative Site 030 | Portland | Oregon | 33709 | United States |
| Forest Investigative Site 056 | Downingtown | Pennsylvania | 19335 | United States |
| Forest Investigative Site 022 | Pelzer | South Carolina | 29669 | United States |
| Forest Investigative Site 053 | Beaumont | Texas | 77701 | United States |
| Forest Investigative Site 066 | Boerne | Texas | 78006 | United States |
| Forest Investigative Site 076 | Corpus Christi | Texas | 78404 | United States |
| Forest Investigative Site 037 | Dallas | Texas | 75234 | United States |
| Forest Investigative Site 043 | Haltom City | Texas | 84070 | United States |
| Forest Investigative Site 015 | Houston | Texas | 77081 | United States |
| Forest Investigative Site 026 | Houston | Texas | 77081 | United States |
| Forest Investigative Site 027 | Houston | Texas | 77081 | United States |
| Forest Investigative Site 074 | Houston | Texas | 77081 | United States |
| Forest Investigative Site 071 | Orem | Utah | 84058 | United States |
| Forest Investigative Site 042 | Sandy City | Utah | 84070 | United States |
| Forest Investigative Site 063 | Norfolk | Virginia | 23502 | United States |
| Forest Investigative Site 064 | Norfolk | Virginia | 23502 | United States |
| Forest Investigative Site 046 | Port Orchard | Washington | 98366 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Dose-matched placebo |
| BG001 | Nebivolol | Nebivolol (non-trade 5, 10 or 20 mg tablet), 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 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 Seated Diastolic Blood Pressure (DBP) | Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach. | 641 patients were randomized to receive double-blind treatment. The Safety population consisted of 641 patients who received at least 1 dose of double-blind treatment. The Intent to Treat population (ITT) consisted of 634 patients who had at least 1 postbaseline seated diastolic blood pressure (DBP) assessment | Posted | Mean | Standard Deviation | mmHG | Change from Baseline to Week 8 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough Seated Systolic Blood Pressure (SBP) | Change from baseline in mean seated trough cuff Systolic Blood Pressure (SBP) at Week 8 as measured by an Omron device. The secondary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach. | 641 patients were randomized to receive double-blind treatment. The Safety population consisted of 641 patients who received at least 1 dose of double-blind treatment. The Intent to Treat population (ITT) consisted of 634 patients who had at least 1 postbaseline seated diastolic blood pressure (DBP) assessment | Posted | Mean | Standard Deviation | mm Hg | Change from Baseline to Week 8 |
|
|
Adverse event data was collected over a 9 month period from August of 2011 to April of 2012
The Safety population consisted of 641 randomized patients who received at least 1 dose of double-blind treatment.
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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 | Placebo | Dose-matched placebo | 4 | 214 | 21 | 214 | ||
| EG001 | Nebivolol | Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration | 4 | 427 | 37 | 427 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersensitivity | Immune system disorders | MedDra (15.0) | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDra (15.0) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDra (15.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDra (15.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDra (15.0) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra (15.0) | Systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDra (15.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDra (15.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDra (15.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDra (15.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra (15.0) | Systematic Assessment |
|
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 | |
|---|---|---|---|---|
| Tatjana Lukic, MD, MSc | Forest Research Institute | (201) 427-8649 | tanya.lukic@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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| Male |
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