Clinical trial NCT01415505: Combination of Nebivolol and Valsartan Given as Free Tablets for Stage 1 or Stage 2 Hypertension
Official title: A Multicenter, Open-Label, Single-Arm, Free Tablet Combination, Long-Term Study to Evaluate the Safety of Nebivolol in Combination With Valsartan in Patients With Stage 1 or Stage 2 Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Stage 1
Stage 2
Hypertension
1 year open label safety study
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2011-08-12
Enrollment: 812
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of nebivolol and valsartan given as a free tablet combination in patient with stage 1 or stage 2 essential hypertension.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatients of age 18 years or above
* Patients diagnosed with stage 1 or stage 2 essential hypertension
* Normal physical examination findings, electrocardiogram (ECG) results and chest x-ray; or abnormal findings judged by the Investigator to be not clinically significant

Exclusion Criteria:

* Secondary hypertension or severe hypertension
* Clinically significant cardiovascular disease or heart failure
* A medical contraindication to discontinuing a current antihypertensive therapy
* History of Type 1 diabetes mellitus

Primary outcomes:
measure: Adverse Event Recording
timeFrame: From Baseline to Week 53 (Visit 16)
Secondary outcomes:
measure: Diastolic Blood Pressure (DBP).
timeFrame: From Baseline to Week 52 (Visit 15)
measure: Systolic Blood Pressure (SBP)
timeFrame: From Baseline to Week 52 (Visit 15)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site 083
state: Alabama
city: Foley
country: United States
facility: Forest Investigative Site 004
state: Alabama
city: Gulf Shores
country: United States
facility: Forest Investigative Site 038
state: Alabama
city: Muscle Shoals
country: United States
facility: Forest Investigative Site 124
state: Alabama
city: Chandler
country: United States
facility: Forest Investigative Site 023
state: Arizona
city: Goodyear
country: United States
facility: Forest Investigative Site 073
state: Arizona
city: Green Valley
country: United States
facility: Forest Investigative Site 100
state: Arizona
city: Mesa
country: United States
facility: Forest Investigative Site 117
state: Arizona
city: Mesa
country: United States
facility: Forest Investigative Site 065
state: Arizona
city: Phoenix
country: United States
facility: Forest Investigative Site 102
state: Arizona
city: Tempe
country: United States
facility: Forest Investigative Site 103
state: Arizona
city: Tempe
country: United States
facility: Forest Investigative Site 068
state: Arizona
city: Jonesboro
country: United States
facility: Forest Investigative Site 066
state: Arkansas
city: Jonesboro
country: United States
facility: Forest Investigative Site 118
state: Arkansas
city: Carmichael
country: United States
facility: Forest Investigative Site 135
state: California
city: Encinitas
country: United States
facility: Forest Investigative Site 064
state: California
city: Encino
country: United States
facility: Forest Investigative Site 046
state: California
city: Glendale
country: United States
facility: Forest Investigative Site 098
state: California
city: Huntington Park
country: United States
facility: Forest Investigative Site 129
state: California
city: Lancaster
country: United States
facility: Forest Investigative Site 136
state: California
city: Long Beach
country: United States
facility: Forest Investigative Site 096
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site 015
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site 025
state: California
city: Mission Hills
country: United States
facility: Forest Investigative Site 101
state: California
city: Palm Springs
country: United States
facility: Forest Investigative Site 089
state: California
city: Pismo Beach
country: United States
facility: Forest Investigative Site 116
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site 138
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 132
state: California
city: San Marino
country: United States
facility: Forest Investigative Site 061
state: California
city: San Ramon
country: United States
facility: Forest Investigative Site 095
state: California
city: Santa Ana
country: United States
facility: Forest Investigative Site 087
state: California
city: Santa Barbara
country: United States
facility: Forest Investigative Site 134
state: California
city: Tustin
country: United States
facility: Forest Investigative Site 062
state: California
city: Tustin
country: United States
facility: Forest Investigative Site 130
state: California
city: West Hills
country: United States
facility: Forest Investigative Site 092
state: California
city: Westlake Village
country: United States
facility: Forest Investigative Site 028
state: California
city: Northglenn
country: United States
facility: Forest Investigative Site 006
state: Colorado
city: Cromwell
country: United States
facility: Forest Investigative Site 030
state: Connecticut
city: Waterbury
country: United States
facility: Forest Investigative Site 018
state: Connecticut
city: Boca Raton
country: United States
facility: Forest Investigative Site 106
state: Florida
city: Brooksville
country: United States
facility: Forest Investigative Site 044
state: Florida
city: Coral Gables
country: United States
facility: Forest Investigative Site 049
state: Florida
city: Cutler Bay
country: United States
facility: Forest Investigative Site 069
state: Florida
city: Daytona Beach
country: United States
facility: Forest Investigative Site 059
state: Florida
city: Fort Lauderdale
country: United States
facility: Forest Investigative Site 048
state: Florida
city: Fort Lauderdale
country: United States
facility: Forest Investigative Site 001
state: Florida
city: Hialeah
country: United States
facility: Forest Investigative Site 002
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 022
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 032
state: Florida
city: New Port Richey
country: United States
facility: Forest Investigative Site 005
state: Florida
city: North Miami Beach
country: United States
facility: Forest Investigative Site 021
state: Florida
city: Ocala
country: United States
facility: Forest Investigative Site 111
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative Site 056
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative Site 127
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative Site 054
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative Site 133
state: Florida
city: Plant City
country: United States
facility: Forest Investigative Site 085
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site 033
state: Florida
city: Winter Haven
country: United States
facility: Forest Investigative Site 008
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 019
state: Georgia
city: Roswell
country: United States
facility: Forest Investigative Site 077
state: Georgia
city: Arlington Heights
country: United States
facility: Forest Investigative Site 126
state: Illinois
city: Chicago
country: United States
facility: Forest Investigative Site 084
state: Illinois
city: Evansville
country: United States
facility: Forest Investigative Site 088
state: Indiana
city: Newton
country: United States
facility: Forest Investigative Site 108
state: Kansas
city: Lexington
country: United States
facility: Forest Investigative Site 050
state: Kentucky
city: Madisonville
country: United States
facility: Forest Investigative Site 003
state: Kentucky
city: Metairie
country: United States
facility: Forest Investigative Site 141
state: Louisiana
city: Auburn
country: United States
facility: Forest Investigative Site 057
state: Maine
city: Baltimore
country: United States
facility: Forest Investigative Site 041
state: Maryland
city: Baltimore
country: United States
facility: Forest Investigative Site 014
state: Maryland
city: Elkridge
country: United States
facility: Forest Investigative Site 080
state: Maryland
city: Haverhill
country: United States
facility: Forest Investigative Site 017
state: Massachusetts
city: Kalamazoo
country: United States
facility: Forest Investigative Site 143
state: Michigan
city: Troy
country: United States
facility: Forest Investigative Site 071
state: Michigan
city: Jackson
country: United States
facility: Forest Investigative Site 086
state: Mississippi
city: Omaha
country: United States
facility: Forest Investigative Site 099
state: Nebraska
city: Las Vegas
country: United States
facility: Forest Investigative Site 120
state: Nevada
city: Las Vegas
country: United States
facility: Forest Investigative Site 119
state: Nevada
city: Las Vegas
country: United States
facility: Forest Investigative Site 121
state: Nevada
city: Berkeley Heights
country: United States
facility: Forest Investigative Site 137
state: New Jersey
city: Binghamton
country: United States
facility: Forest Investigative Site 047
state: New York
city: Rosedale
country: United States
facility: Forest Investigative Site 072
state: New York
city: Saratoga Springs
country: United States
facility: Forest Investigative Site 128
state: New York
city: Charlotte
country: United States
facility: Forest Investigative Site 042
state: North Carolina
city: Greensboro
country: United States
facility: Forest Investigative Site 139
state: North Carolina
city: Hickory
country: United States
facility: Forest Investigative Site 007
state: North Carolina
city: Lenoir
country: United States
facility: Forest Investigative Site 114
state: North Carolina
city: Salisbury
country: United States
facility: Forest Investigative Site 081
state: North Carolina
city: Shelby
country: United States
facility: Forest Investigative Site 013
state: North Carolina
city: Wilmington
country: United States
facility: Forest Investigative Site 011
state: North Carolina
city: Winston-Salem
country: United States
facility: Forest Investigative Site 036
state: North Carolina
city: Cincinnati
country: United States
facility: Forest Investigative Site 009
state: Ohio
city: Kettering
country: United States
facility: Forest Investigative Site 125
state: Ohio
city: Marion
country: United States
facility: Forest Investigative Site 094
state: Ohio
city: Mount Gilead
country: United States
facility: Forest Investigative Site 093
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 112
state: Oklahoma
city: Eugene
country: United States
facility: Forest Investigative Site 104
state: Oregon
city: Beaver
country: United States
facility: Forest Investigative Site 058
state: Pennsylvania
city: Penndel
country: United States
facility: Forest Investigative Site 131
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site 105
state: Pennsylvania
city: Upper St. Clair
country: United States
facility: Forest Investigative Site 039
state: Pennsylvania
city: Charleston
country: United States
facility: Forest Investigative Site 012
state: South Carolina
city: Columbia
country: United States
facility: Forest Investigative Site 040
state: South Carolina
city: Greer
country: United States
facility: Forest Investigative Site 060
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Forest Investigative Site 035
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Forest Investigative Site 082
state: South Carolina
city: Simpsonville
country: United States
facility: Forest Investigative Site 142
state: South Carolina
city: Summerville
country: United States
facility: Forest Investigative Site 045
state: South Carolina
city: Bristol
country: United States
facility: Forest Investigative Site 113
state: Tennessee
city: Fayetteville
country: United States
facility: Forest Investigative Site 034
state: Tennessee
city: Franklin
country: United States
facility: Forest Investigative Site 070
state: Tennessee
city: Arlington
country: United States
facility: Forest Investigative Site 016
state: Texas
city: Carrollton
country: United States
facility: Forest Investigative Site 063
state: Texas
city: Dallas
country: United States
facility: Forest Investigative Site 123
state: Texas
city: Fort Worth
country: United States
facility: Forest Investigative Site 079
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 052
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 024
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 026
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 027
state: Texas
city: Plano
country: United States
facility: Forest Investigative Site 140
state: Texas
city: San Angelo
country: United States
facility: Forest Investigative Site 091
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 055
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 115
state: Texas
city: Sugar Land
country: United States
facility: Forest Investigative Site 078
state: Texas
city: Salt Lake City
country: United States
facility: Forest Investigative Site 090
state: Utah
city: Salt Lake City
country: United States
facility: Forest Investigative Site 053
state: Utah
city: St. George
country: United States
facility: Forest Investigative Site 051
state: Utah
city: Alexandria
country: United States
facility: Forest Investigative Site 110
state: Virginia
city: Burke
country: United States
facility: Forest Investigative Site 074
state: Virginia
city: Manassas
country: United States
facility: Forest Investigative Site 067
state: Virginia
city: Norfolk
country: United States
facility: Forest Investigative Site 037
state: Virginia
city: Suffolk
country: United States
facility: Forest Investigative Site 122
state: Virginia
city: Virginia Beach
country: United States
facility: Forest Investigative Site 010
state: Virginia
city: Tacoma
country: United States
facility: Forest Investigative Site 107
state: Washington
Study officials:
affiliation: Forest Laboratories
name: David B Bharucha, MD, PhD, FACC
role: STUDY_DIRECTOR
References:
citation: Neutel JM, Giles TD, Punzi H, Weiss RJ, Li H, Finck A. Long-term safety of nebivolol and valsartan combination therapy in patients with hypertension: an open-label, single-arm, multicenter study. J Am Soc Hypertens. 2014 Dec;8(12):915-20. doi: 10.1016/j.jash.2014.09.017. Epub 2014 Sep 28.