Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the safety and efficacy of first-line treatment with a free combination (as two separate pills) of nebivolol and lisinopril in patients with stage 2 diastolic hypertension (DBP>= 100 mmHg).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Combination group - starting dose level nebivolol 5mg and lisinopril 10mg |
|
| 2 | Active Comparator | Nebivolol monotherapy group - starting dose level nebivolol 5mg |
|
| 3 | Active Comparator | Lisinopril monotherapy group - starting dose level lisinopril 10mg |
|
| 4 | Placebo Comparator | Placebo group - starting dose is placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nebivolol and lisinopril (free combination) | Drug | nebivolol 5-mg and lisinopril 10-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 10-mg tablet)/QD/oral administration/up to 12 weeks nebivolol 20-mg and lisinopril 40-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 10 weeks nebivolol 5-mg and lisinopril 40-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 6 weeks nebivolol 20-mg and lisinopril 10-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 10-mg tablet/QD/oral administration/up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6. | Visit 6/(Week 0) and Visit 9/(Week 6) |
| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6. | Visit 6/(Week 0) and Visit 9/(Week 6) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Manfred Stapff, MD PhD | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site #58 | Scottsdale | Arizona | 85254 | United States | ||
| Forest Investigative site 080 |
664 patients were randomized to receive double-blind treatment; 661 patients received at least 1 dose of double-blind treatment (Safety Population); and 656 patients had at least 1 postbaseline assessment of trough seated DBP (ITT Population)
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo group - starting dose is placebo |
| FG001 | Nebivolol + Lisinopril (Combination) | Combination group - starting dose level nebivolol 5mg and lisinopril 10mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| nebivolol monotherapy | Drug | nebivolol 5-mg (non-trade 5-mg tablet)/QD/oral administration/up to 12 weeks nebivolol 10-mg (non-trade 10-mg tablet/QD/oral administration/for 1-week down-titration period only) nebivolol 20-mg (non-trade 20-mg tablet)/QD/oral administration/up to 10 weeks |
|
| lisinopril monotherapy | Drug | lisinopril 10-mg (overencapsulated 10-mg tablet)/QD/oral administration/up to 12 weeks lisinopril 40-mg (overencapsulated 40-mg tablet)/QD/oral administration/up to 10 weeks |
|
| placebo | Drug | Placebo tablet, oral administration/QD/oral administration/up to 12 weeks Placebo capsule, oral administration/QD/oral administration/up to 12 weeks |
|
| Tempe |
| Arizona |
| 85282 |
| United States |
| Forest Investigative site 096 | Tucson | Arizona | 85741 | United States |
| Forest Investigative site 038 | Buena Park | California | 90620 | United States |
| Forest Investigative site 075 | Burbank | California | 91505 | United States |
| Forest Investigative site 042 | Costa Mesa | California | 92626 | United States |
| Forest Investigative site 028 | Fountain Valley | California | 92708 | United States |
| Forest Investigative site 064 | Fresno | California | 93726 | United States |
| Forest Investigative site 079 | Lancaster | California | 93539 | United States |
| Forest Investigative site 097 | Long Beach | California | 90806 | United States |
| Forest Investigative site 049 | Los Angeles | California | 90057 | United States |
| Forest Investigative site 081 | Riverside | California | 92506 | United States |
| Forest Investigative site 040 | San Marino | California | 91108 | United States |
| Forest Investigative site 059 | San Ramon | California | 94583 | United States |
| Forest Investigative site 074 | Santa Ana | California | 92705 | United States |
| Forest Investigative site 072 | Tustin | California | 92780 | United States |
| Forest Investigative site 077 | Colorado Springs | Colorado | 80909 | United States |
| Forest Investigative site 050 | Waterbury | Connecticut | 06708 | United States |
| Forest Investigative site 019 | Boca Raton | Florida | 33432 | United States |
| Forest Investigative site 056 | Brandon | Florida | 33511 | United States |
| Forest Investigative site 043 | Brooksville | Florida | 34601 | United States |
| Forest Investigative site 035 | Fort Lauderdale | Florida | 33306 | United States |
| Forest Investigative site 002 | Hialeah | Florida | 33012 | United States |
| Forest Investigative site 003 | Miami | Florida | 33014 | United States |
| Forest Investigative site 067 | Miami | Florida | 33133 | United States |
| Forest Investigative site 057 | Miami | Florida | 33143 | United States |
| Forest Investigative site 068 | Miami | Florida | 33169 | United States |
| Forest Investigative site 007 | Miami | Florida | 33183 | United States |
| Forest Investigative site 009 | New Port Richey | Florida | 34652 | United States |
| Forest Investigative site 036 | Pembroke Pines | Florida | 33024 | United States |
| Forest Investigative site 005 | Pembroke Pines | Florida | 33028 | United States |
| Forest Investigative site 001 | St. Petersburg | Florida | 33709 | United States |
| Forest Investigative site 004 | Tampa | Florida | 33606 | United States |
| Forest Investigative site 046 | Tampa | Florida | 33614 | United States |
| Forest Investigative site 076 | Atlanta | Georgia | 30338 | United States |
| Forest Investigative site 055 | Stockbridge | Georgia | 30281 | United States |
| Forest Investigative Site 070 | Honolulu | Hawaii | 96814 | United States |
| Forest Investigative site 008 | Meridian | Idaho | 83646 | United States |
| Forest Investigative site 016 | Chicago | Illinois | 60490 | United States |
| Forest Investigative site 085 | Chicago | Illinois | 60607 | United States |
| Forest Investigative site 082 | Chicago | Illinois | 60611 | United States |
| Forest Investigative site 039 | Morton | Illinois | 61550 | United States |
| Forest Investigative site 087 | Louisville | Kentucky | 40213 | United States |
| Forest Investigative site 099 | Madisonville | Kentucky | 42431 | United States |
| Forest Investigative site 060 | Owensboro | Kentucky | 42303 | United States |
| Forest Investigative site 030 | New Orleans | Louisiana | 70115 | United States |
| Forest Investigative site 069 | Balitmore | Maryland | 21209 | United States |
| Forest Investigative site 021 | Baltimore | Maryland | 21204 | United States |
| Forest Investigative site 014 | Baltimore | Maryland | 21236 | United States |
| Forest Investigative site 054 | Brockton | Massachusetts | 02301 | United States |
| Forest Investigative site 095 | St Louis | Missouri | 63128 | United States |
| Forest Investigative site 010 | Las Vegas | Nevada | 89104 | United States |
| Forest Investigative site 012 | Las Vegas | Nevada | 89106 | United States |
| Forest Investigative site 020 | Elizabeth | New Jersey | 07202 | United States |
| Forest Investigative site 065 | Asheboro | North Carolina | 27203 | United States |
| Forest Investigative site 034 | Charlotte | North Carolina | 28204 | United States |
| Forest Investigative site 086 | Charlotte | North Carolina | 28209 | United States |
| Forest Investigative site 089 | Hickory | North Carolina | 28601 | United States |
| Forest Investigative site 094 | Hickory | North Carolina | 28602 | United States |
| Forest Investigative site 027 | Lenoir | North Carolina | 28645 | United States |
| Forest Investigative site 101 | Raleigh | North Carolina | 27609 | United States |
| Forest Investigative site 024 | Raleigh | North Carolina | 27612 | United States |
| Forest Investigative site 013 | Shelby | North Carolina | 28150 | United States |
| Forest Investigative site 022 | Winston-Salem | North Carolina | 27103 | United States |
| Forest Investigative site 098 | Cincinnati | Ohio | 45227 | United States |
| Forest Investigative site 084 | Columbus | Ohio | 43213 | United States |
| Forest Investigative site 026 | Dayton | Ohio | 45406 | United States |
| Forest Investigative site 051 | Zanesville | Ohio | 43701 | United States |
| Forest Investigative site 053 | Norman | Oklahoma | 73069 | United States |
| Forest Investigative site 062 | Ashland | Oregon | 97520 | United States |
| Forest Investigative site 011 | Broomall | Pennsylvania | 19008 | United States |
| Forest Investigative site 061 | Philadelphia | Pennsylvania | 19146 | United States |
| Forest Investigative site 015 | Tipton | Pennsylvania | 16684 | United States |
| Forest Investigative site 045 | Cranston | Rhode Island | 02920 | United States |
| Forest Investigative site 066 | Charleston | South Carolina | 29407 | United States |
| Forest Investigative site 048 | Greer | South Carolina | 29651 | United States |
| Forest Investigative site 093 | Mt. Pleasant | South Carolina | 49464 | United States |
| Forest Investigative site 052 | Fayetteville | Tennessee | 37334 | United States |
| Forest Investigative site 025 | Carrollton | Texas | 75006 | United States |
| Forest Investigative site 006 | Houston | Texas | 77074 | United States |
| Forest Investigative site 029 | Houston | Texas | 77074 | United States |
| Forest Investigative site 047 | San Antonio | Texas | 78205 | United States |
| Forest Investigative site 071 | San Antonio | Texas | 78229 | United States |
| Forest Investigative site 018 | Salt Lake City | Utah | 84102 | United States |
| Forest Investigative site 100 | Salt Lake City | Utah | 84124 | United States |
| Forest Investigative site 023 | St. George | Utah | 84790 | United States |
| Forest Investigative site 031 | Norfolk | Virginia | 23507 | United States |
| Forest Investigative site 041 | Norfolk | Virginia | 23510 | United States |
| Forest Investigative site 078 | Tacoma | Washington | 98405 | United States |
| Forest Investigative site 044 | Caguas | 00725 | Puerto Rico |
| FG002 | Nebivolol | Nebivolol monotherapy group - starting dose level nebivolol 5mg |
| FG003 | Lisinopril | Lisinopril monotherapy group - starting dose level lisinopril 10mg |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo group - starting dose is placebo |
| BG001 | Nebivolol + Lisinopril (Combination) | Combination group - starting dose level nebivolol 5mg and lisinopril 10mg |
| BG002 | Nebivolol | Nebivolol monotherapy group - starting dose level nebivolol 5mg |
| BG003 | Lisinopril | Lisinopril monotherapy group - starting dose level lisinopril 10mg |
| BG004 | 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 | The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6. | Posted | Mean | Standard Deviation | mm HG | Visit 6/(Week 0) and Visit 9/(Week 6) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | The Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6. | Posted | Mean | Standard Deviation | mm HG | Visit 6/(Week 0) and Visit 9/(Week 6) |
|
|
Adverse event reporting occurred from October 6th, 2010 to May 18th, 2011.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo group - starting dose is placebo | 2 | 95 | 15 | 95 | ||
| EG001 | Nebivolol + Lisinopril (Combination) | Combination group - starting dose level nebivolol 5mg and lisinopril 10mg | 2 | 189 | 31 | 189 | ||
| EG002 | Nebivolol | Nebivolol monotherapy group - starting dose level nebivolol 5mg | 3 | 188 | 32 | 188 | ||
| EG003 | Lisinopril | Lisinopril monotherapy group - starting dose level lisinopril 10mg | 4 | 189 | 24 | 189 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Cerebrovascular accident | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Duodenal ulcer perforation | General disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Throat cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | 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 | |
|---|---|---|---|---|
| Manfred Stapff, MD, PhD | Forest Research Institute | 201-427-8000 | Manfred.stapff@frx.com |
| ID | Term |
|---|---|
| D000068577 | Nebivolol |
| D017706 | Lisinopril |
| 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 |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|