Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monotherapy in Patients With Stage 2 Diastolic Hypertension
- Conditions
- Stage 2 Diastolic Hypertension
- Interventions
- Registration Number
- NCT01218100
- Lead Sponsor
- Forest Laboratories
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 664
- male and female outpatients 18 to 64 years of age
- Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
- stage 2 diastolic hypertension (DBP >= 100 mmHg)
- secondary hypertension
- evidence of other concurrent disease or conditions that might interfere with the conduct of the study
- participation in an investigational drug study within 30 days or 5 half-lives, whichever is longer, of Screening (Visit 1).
- have a history of hypersensitivity to nebivolol or other β-blockers, or any contraindication to β-blocker use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 nebivolol and lisinopril (free combination) Combination group - starting dose level nebivolol 5mg and lisinopril 10mg 2 nebivolol monotherapy Nebivolol monotherapy group - starting dose level nebivolol 5mg 3 lisinopril monotherapy Lisinopril monotherapy group - starting dose level lisinopril 10mg 4 placebo Placebo group - starting dose is placebo
- Primary Outcome Measures
Name Time Method The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6. Visit 6/(Week 0) and Visit 9/(Week 6)
- Secondary Outcome Measures
Name Time Method The Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6. Visit 6/(Week 0) and Visit 9/(Week 6)
Trial Locations
- Locations (90)
Forest Investigative site 079
🇺🇸Lancaster, California, United States
Forest Investigative site 021
🇺🇸Baltimore, Maryland, United States
Forest Investigative site 016
🇺🇸Chicago, Illinois, United States
Forest Investigative site 082
🇺🇸Chicago, Illinois, United States
Forest Investigative site 053
🇺🇸Norman, Oklahoma, United States
Forest Investigative site 020
🇺🇸Elizabeth, New Jersey, United States
Forest Investigative site 006
🇺🇸Houston, Texas, United States
Forest Investigative site 029
🇺🇸Houston, Texas, United States
Forest Investigative site 081
🇺🇸Riverside, California, United States
Forest Investigative site 072
🇺🇸Tustin, California, United States
Forest Investigative site 049
🇺🇸Los Angeles, California, United States
Forest Investigative site 074
🇺🇸Santa Ana, California, United States
Forest Investigative site 036
🇺🇸Pembroke Pines, Florida, United States
Forest Investigative site 059
🇺🇸San Ramon, California, United States
Forest Investigative site 035
🇺🇸Fort Lauderdale, Florida, United States
Forest Investigative site 040
🇺🇸San Marino, California, United States
Forest Investigative site 050
🇺🇸Waterbury, Connecticut, United States
Forest Investigative site 077
🇺🇸Colorado Springs, Colorado, United States
Forest Investigative site 019
🇺🇸Boca Raton, Florida, United States
Forest Investigative site 009
🇺🇸New Port Richey, Florida, United States
Forest Investigative site 002
🇺🇸Hialeah, Florida, United States
Forest Investigative site 056
🇺🇸Brandon, Florida, United States
Forest Investigative site 043
🇺🇸Brooksville, Florida, United States
Forest Investigative site 003
🇺🇸Miami, Florida, United States
Forest Investigative site 067
🇺🇸Miami, Florida, United States
Forest Investigative site 057
🇺🇸Miami, Florida, United States
Forest Investigative site 068
🇺🇸Miami, Florida, United States
Forest Investigative site 007
🇺🇸Miami, Florida, United States
Forest Investigative site 010
🇺🇸Las Vegas, Nevada, United States
Forest Investigative site 012
🇺🇸Las Vegas, Nevada, United States
Forest Investigative site 098
🇺🇸Cincinnati, Ohio, United States
Forest Investigative site 071
🇺🇸San Antonio, Texas, United States
Forest Investigative site 018
🇺🇸Salt Lake City, Utah, United States
Forest Investigative site 100
🇺🇸Salt Lake City, Utah, United States
Forest Investigative site 001
🇺🇸St. Petersburg, Florida, United States
Forest Investigative site 080
🇺🇸Tempe, Arizona, United States
Forest Investigative Site #58
🇺🇸Scottsdale, Arizona, United States
Forest Investigative site 096
🇺🇸Tucson, Arizona, United States
Forest Investigative site 038
🇺🇸Buena Park, California, United States
Forest Investigative site 042
🇺🇸Costa Mesa, California, United States
Forest Investigative site 028
🇺🇸Fountain Valley, California, United States
Forest Investigative site 075
🇺🇸Burbank, California, United States
Forest Investigative site 097
🇺🇸Long Beach, California, United States
Forest Investigative site 064
🇺🇸Fresno, California, United States
Forest Investigative site 005
🇺🇸Pembroke Pines, Florida, United States
Forest Investigative site 076
🇺🇸Atlanta, Georgia, United States
Forest Investigative site 055
🇺🇸Stockbridge, Georgia, United States
Forest Investigative site 008
🇺🇸Meridian, Idaho, United States
Forest Investigative site 085
🇺🇸Chicago, Illinois, United States
Forest Investigative site 060
🇺🇸Owensboro, Kentucky, United States
Forest Investigative site 039
🇺🇸Morton, Illinois, United States
Forest Investigative site 099
🇺🇸Madisonville, Kentucky, United States
Forest Investigative site 069
🇺🇸Balitmore, Maryland, United States
Forest Investigative site 054
🇺🇸Brockton, Massachusetts, United States
Forest Investigative site 014
🇺🇸Baltimore, Maryland, United States
Forest Investigative site 065
🇺🇸Asheboro, North Carolina, United States
Forest Investigative site 095
🇺🇸St. Louis, Missouri, United States
Forest Investigative site 086
🇺🇸Charlotte, North Carolina, United States
Forest Investigative site 089
🇺🇸Hickory, North Carolina, United States
Forest Investigative site 034
🇺🇸Charlotte, North Carolina, United States
Forest Investigative site 094
🇺🇸Hickory, North Carolina, United States
Forest Investigative site 027
🇺🇸Lenoir, North Carolina, United States
Forest Investigative site 024
🇺🇸Raleigh, North Carolina, United States
Forest Investigative site 101
🇺🇸Raleigh, North Carolina, United States
Forest Investigative site 013
🇺🇸Shelby, North Carolina, United States
Forest Investigative site 026
🇺🇸Dayton, Ohio, United States
Forest Investigative site 051
🇺🇸Zanesville, Ohio, United States
Forest Investigative site 062
🇺🇸Ashland, Oregon, United States
Forest Investigative site 084
🇺🇸Columbus, Ohio, United States
Forest Investigative site 011
🇺🇸Broomall, Pennsylvania, United States
Forest Investigative site 061
🇺🇸Philadelphia, Pennsylvania, United States
Forest Investigative site 015
🇺🇸Tipton, Pennsylvania, United States
Forest Investigative site 045
🇺🇸Cranston, Rhode Island, United States
Forest Investigative site 048
🇺🇸Greer, South Carolina, United States
Forest Investigative site 025
🇺🇸Carrollton, Texas, United States
Forest Investigative site 052
🇺🇸Fayetteville, Tennessee, United States
Forest Investigative site 093
🇺🇸Mount Pleasant, South Carolina, United States
Forest Investigative site 047
🇺🇸San Antonio, Texas, United States
Forest Investigative site 023
🇺🇸St. George, Utah, United States
Forest Investigative site 031
🇺🇸Norfolk, Virginia, United States
Forest Investigative site 044
🇵🇷Caguas, Puerto Rico
Forest Investigative site 041
🇺🇸Norfolk, Virginia, United States
Forest Investigative site 078
🇺🇸Tacoma, Washington, United States
Forest Investigative site 004
🇺🇸Tampa, Florida, United States
Forest Investigative site 046
🇺🇸Tampa, Florida, United States
Forest Investigative Site 070
🇺🇸Honolulu, Hawaii, United States
Forest Investigative site 087
🇺🇸Louisville, Kentucky, United States
Forest Investigative site 030
🇺🇸New Orleans, Louisiana, United States
Forest Investigative site 022
🇺🇸Winston-Salem, North Carolina, United States
Forest Investigative site 066
🇺🇸Charleston, South Carolina, United States