Clinical trial NCT01218100: Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monotherapy in Patients With Stage 2 Diastolic Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stage 2 Diastolic Hypertension
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2010-10-11
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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 β-blockers, or any contraindication to β-blocker use

Primary outcomes:
measure: The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6.
timeFrame: Visit 6/(Week 0) and Visit 9/(Week 6)
Secondary outcomes:
measure: The Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6.
timeFrame: Visit 6/(Week 0) and Visit 9/(Week 6)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Forest Investigative Site #58
state: Arizona
city: Tempe
country: United States
facility: Forest Investigative site 080
state: Arizona
city: Tucson
country: United States
facility: Forest Investigative site 096
state: Arizona
city: Buena Park
country: United States
facility: Forest Investigative site 038
state: California
city: Burbank
country: United States
facility: Forest Investigative site 075
state: California
city: Costa Mesa
country: United States
facility: Forest Investigative site 042
state: California
city: Fountain Valley
country: United States
facility: Forest Investigative site 028
state: California
city: Fresno
country: United States
facility: Forest Investigative site 064
state: California
city: Lancaster
country: United States
facility: Forest Investigative site 079
state: California
city: Long Beach
country: United States
facility: Forest Investigative site 097
state: California
city: Los Angeles
country: United States
facility: Forest Investigative site 049
state: California
city: Riverside
country: United States
facility: Forest Investigative site 081
state: California
city: San Marino
country: United States
facility: Forest Investigative site 040
state: California
city: San Ramon
country: United States
facility: Forest Investigative site 059
state: California
city: Santa Ana
country: United States
facility: Forest Investigative site 074
state: California
city: Tustin
country: United States
facility: Forest Investigative site 072
state: California
city: Colorado Springs
country: United States
facility: Forest Investigative site 077
state: Colorado
city: Waterbury
country: United States
facility: Forest Investigative site 050
state: Connecticut
city: Boca Raton
country: United States
facility: Forest Investigative site 019
state: Florida
city: Brandon
country: United States
facility: Forest Investigative site 056
state: Florida
city: Brooksville
country: United States
facility: Forest Investigative site 043
state: Florida
city: Fort Lauderdale
country: United States
facility: Forest Investigative site 035
state: Florida
city: Hialeah
country: United States
facility: Forest Investigative site 002
state: Florida
city: Miami
country: United States
facility: Forest Investigative site 003
state: Florida
city: Miami
country: United States
facility: Forest Investigative site 067
state: Florida
city: Miami
country: United States
facility: Forest Investigative site 057
state: Florida
city: Miami
country: United States
facility: Forest Investigative site 068
state: Florida
city: Miami
country: United States
facility: Forest Investigative site 007
state: Florida
city: New Port Richey
country: United States
facility: Forest Investigative site 009
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative site 036
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative site 005
state: Florida
city: St. Petersburg
country: United States
facility: Forest Investigative site 001
state: Florida
city: Tampa
country: United States
facility: Forest Investigative site 004
state: Florida
city: Tampa
country: United States
facility: Forest Investigative site 046
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative site 076
state: Georgia
city: Stockbridge
country: United States
facility: Forest Investigative site 055
state: Georgia
city: Honolulu
country: United States
facility: Forest Investigative Site 070
state: Hawaii
city: Meridian
country: United States
facility: Forest Investigative site 008
state: Idaho
city: Chicago
country: United States
facility: Forest Investigative site 016
state: Illinois
city: Chicago
country: United States
facility: Forest Investigative site 085
state: Illinois
city: Chicago
country: United States
facility: Forest Investigative site 082
state: Illinois
city: Morton
country: United States
facility: Forest Investigative site 039
state: Illinois
city: Louisville
country: United States
facility: Forest Investigative site 087
state: Kentucky
city: Madisonville
country: United States
facility: Forest Investigative site 099
state: Kentucky
city: Owensboro
country: United States
facility: Forest Investigative site 060
state: Kentucky
city: New Orleans
country: United States
facility: Forest Investigative site 030
state: Louisiana
city: Balitmore
country: United States
facility: Forest Investigative site 069
state: Maryland
city: Baltimore
country: United States
facility: Forest Investigative site 021
state: Maryland
city: Baltimore
country: United States
facility: Forest Investigative site 014
state: Maryland
city: Brockton
country: United States
facility: Forest Investigative site 054
state: Massachusetts
city: St. Louis
country: United States
facility: Forest Investigative site 095
state: Missouri
city: Las Vegas
country: United States
facility: Forest Investigative site 010
state: Nevada
city: Las Vegas
country: United States
facility: Forest Investigative site 012
state: Nevada
city: Elizabeth
country: United States
facility: Forest Investigative site 020
state: New Jersey
city: Asheboro
country: United States
facility: Forest Investigative site 065
state: North Carolina
city: Charlotte
country: United States
facility: Forest Investigative site 034
state: North Carolina
city: Charlotte
country: United States
facility: Forest Investigative site 086
state: North Carolina
city: Hickory
country: United States
facility: Forest Investigative site 089
state: North Carolina
city: Hickory
country: United States
facility: Forest Investigative site 094
state: North Carolina
city: Lenoir
country: United States
facility: Forest Investigative site 027
state: North Carolina
city: Raleigh
country: United States
facility: Forest Investigative site 101
state: North Carolina
city: Raleigh
country: United States
facility: Forest Investigative site 024
state: North Carolina
city: Shelby
country: United States
facility: Forest Investigative site 013
state: North Carolina
city: Winston-Salem
country: United States
facility: Forest Investigative site 022
state: North Carolina
city: Cincinnati
country: United States
facility: Forest Investigative site 098
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative site 084
state: Ohio
city: Dayton
country: United States
facility: Forest Investigative site 026
state: Ohio
city: Zanesville
country: United States
facility: Forest Investigative site 051
state: Ohio
city: Norman
country: United States
facility: Forest Investigative site 053
state: Oklahoma
city: Ashland
country: United States
facility: Forest Investigative site 062
state: Oregon
city: Broomall
country: United States
facility: Forest Investigative site 011
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative site 061
state: Pennsylvania
city: Tipton
country: United States
facility: Forest Investigative site 015
state: Pennsylvania
city: Cranston
country: United States
facility: Forest Investigative site 045
state: Rhode Island
city: Charleston
country: United States
facility: Forest Investigative site 066
state: South Carolina
city: Greer
country: United States
facility: Forest Investigative site 048
state: South Carolina
city: Mount Pleasant
country: United States
facility: Forest Investigative site 093
state: South Carolina
city: Fayetteville
country: United States
facility: Forest Investigative site 052
state: Tennessee
city: Carrollton
country: United States
facility: Forest Investigative site 025
state: Texas
city: Houston
country: United States
facility: Forest Investigative site 006
state: Texas
city: Houston
country: United States
facility: Forest Investigative site 029
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative site 047
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative site 071
state: Texas
city: Salt Lake City
country: United States
facility: Forest Investigative site 018
state: Utah
city: Salt Lake City
country: United States
facility: Forest Investigative site 100
state: Utah
city: St. George
country: United States
facility: Forest Investigative site 023
state: Utah
city: Norfolk
country: United States
facility: Forest Investigative site 031
state: Virginia
city: Norfolk
country: United States
facility: Forest Investigative site 041
state: Virginia
city: Tacoma
country: United States
facility: Forest Investigative site 078
state: Washington
city: Caguas
country: Puerto Rico
facility: Forest Investigative site 044
Study officials:
affiliation: Forest Laboratories
name: Manfred Stapff, MD PhD
role: STUDY_DIRECTOR
References: