Stage 2 Diastolic Hypertension Clinical Trial
Official title:
A Randomized, Double-blind, Parallel-Group Study to Evaluate the Effects of First-Line Treatment With a Free Combination of Nebivolol and Lisinopril Compared With Placebo and the Monotherapy Components on Blood Pressure in Patients With Stage 2 Diastolic Hypertension
| Verified date | May 2012 |
| Source | Forest Laboratories |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 664 |
| Est. completion date | June 2011 |
| Est. primary completion date | May 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 64 Years |
| Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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 ß-blockers, or any contraindication to ß-blocker use |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Forest Investigative site 044 | Caguas | |
| United States | Forest Investigative site 065 | Asheboro | North Carolina |
| United States | Forest Investigative site 062 | Ashland | Oregon |
| United States | Forest Investigative site 076 | Atlanta | Georgia |
| United States | Forest Investigative site 069 | Balitmore | Maryland |
| United States | Forest Investigative site 014 | Baltimore | Maryland |
| United States | Forest Investigative site 021 | Baltimore | Maryland |
| United States | Forest Investigative site 019 | Boca Raton | Florida |
| United States | Forest Investigative site 056 | Brandon | Florida |
| United States | Forest Investigative site 054 | Brockton | Massachusetts |
| United States | Forest Investigative site 043 | Brooksville | Florida |
| United States | Forest Investigative site 011 | Broomall | Pennsylvania |
| United States | Forest Investigative site 038 | Buena Park | California |
| United States | Forest Investigative site 075 | Burbank | California |
| United States | Forest Investigative site 025 | Carrollton | Texas |
| United States | Forest Investigative site 066 | Charleston | South Carolina |
| United States | Forest Investigative site 034 | Charlotte | North Carolina |
| United States | Forest Investigative site 086 | Charlotte | North Carolina |
| United States | Forest Investigative site 016 | Chicago | Illinois |
| United States | Forest Investigative site 082 | Chicago | Illinois |
| United States | Forest Investigative site 085 | Chicago | Illinois |
| United States | Forest Investigative site 098 | Cincinnati | Ohio |
| United States | Forest Investigative site 077 | Colorado Springs | Colorado |
| United States | Forest Investigative site 084 | Columbus | Ohio |
| United States | Forest Investigative site 042 | Costa Mesa | California |
| United States | Forest Investigative site 045 | Cranston | Rhode Island |
| United States | Forest Investigative site 026 | Dayton | Ohio |
| United States | Forest Investigative site 020 | Elizabeth | New Jersey |
| United States | Forest Investigative site 052 | Fayetteville | Tennessee |
| United States | Forest Investigative site 035 | Fort Lauderdale | Florida |
| United States | Forest Investigative site 028 | Fountain Valley | California |
| United States | Forest Investigative site 064 | Fresno | California |
| United States | Forest Investigative site 048 | Greer | South Carolina |
| United States | Forest Investigative site 002 | Hialeah | Florida |
| United States | Forest Investigative site 089 | Hickory | North Carolina |
| United States | Forest Investigative site 094 | Hickory | North Carolina |
| United States | Forest Investigative Site 070 | Honolulu | Hawaii |
| United States | Forest Investigative site 006 | Houston | Texas |
| United States | Forest Investigative site 029 | Houston | Texas |
| United States | Forest Investigative site 079 | Lancaster | California |
| United States | Forest Investigative site 010 | Las Vegas | Nevada |
| United States | Forest Investigative site 012 | Las Vegas | Nevada |
| United States | Forest Investigative site 027 | Lenoir | North Carolina |
| United States | Forest Investigative site 097 | Long Beach | California |
| United States | Forest Investigative site 049 | Los Angeles | California |
| United States | Forest Investigative site 087 | Louisville | Kentucky |
| United States | Forest Investigative site 099 | Madisonville | Kentucky |
| United States | Forest Investigative site 008 | Meridian | Idaho |
| United States | Forest Investigative site 003 | Miami | Florida |
| United States | Forest Investigative site 007 | Miami | Florida |
| United States | Forest Investigative site 057 | Miami | Florida |
| United States | Forest Investigative site 067 | Miami | Florida |
| United States | Forest Investigative site 068 | Miami | Florida |
| United States | Forest Investigative site 039 | Morton | Illinois |
| United States | Forest Investigative site 093 | Mount Pleasant | South Carolina |
| United States | Forest Investigative site 030 | New Orleans | Louisiana |
| United States | Forest Investigative site 009 | New Port Richey | Florida |
| United States | Forest Investigative site 031 | Norfolk | Virginia |
| United States | Forest Investigative site 041 | Norfolk | Virginia |
| United States | Forest Investigative site 053 | Norman | Oklahoma |
| United States | Forest Investigative site 060 | Owensboro | Kentucky |
| United States | Forest Investigative site 005 | Pembroke Pines | Florida |
| United States | Forest Investigative site 036 | Pembroke Pines | Florida |
| United States | Forest Investigative site 061 | Philadelphia | Pennsylvania |
| United States | Forest Investigative site 024 | Raleigh | North Carolina |
| United States | Forest Investigative site 101 | Raleigh | North Carolina |
| United States | Forest Investigative site 081 | Riverside | California |
| 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 047 | San Antonio | Texas |
| United States | Forest Investigative site 071 | San Antonio | Texas |
| United States | Forest Investigative site 040 | San Marino | California |
| United States | Forest Investigative site 059 | San Ramon | California |
| United States | Forest Investigative site 074 | Santa Ana | California |
| United States | Forest Investigative Site #58 | Scottsdale | Arizona |
| United States | Forest Investigative site 013 | Shelby | North Carolina |
| United States | Forest Investigative site 023 | St. George | Utah |
| United States | Forest Investigative site 095 | St. Louis | Missouri |
| United States | Forest Investigative site 001 | St. Petersburg | Florida |
| United States | Forest Investigative site 055 | Stockbridge | Georgia |
| 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 080 | Tempe | Arizona |
| United States | Forest Investigative site 015 | Tipton | Pennsylvania |
| United States | Forest Investigative site 096 | Tucson | Arizona |
| United States | Forest Investigative site 072 | Tustin | California |
| United States | Forest Investigative site 050 | Waterbury | Connecticut |
| United States | Forest Investigative site 022 | Winston-Salem | North Carolina |
| United States | Forest Investigative site 051 | Zanesville | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Forest Laboratories |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6. | Visit 6/(Week 0) and Visit 9/(Week 6) | No | |
| Secondary | The Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6. | Visit 6/(Week 0) and Visit 9/(Week 6) | No |