CClinicalTrials.gg
CompletedNCT01415505Updated Jun 4, 2013

Combination of Nebivolol and Valsartan Given as Free Tablets for Stage 1 or Stage 2 Hypertension

A Phase 3 interventional study of Nebivolol, Valsartan and Hydrochlorothiazide in Hypertension, sponsored by Forest Laboratories. Completed at 135 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-04.

Sponsored by Forest Laboratories · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
812
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension

Browse trials for

Keywords

  • Stage 1
  • Stage 2
  • Hypertension
  • 1 year open label safety study
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 812 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
812 participants (actual)

Study arms

  • Other
    1

    Nebivolol and Valsartan free tablet combination

    Drug: Nebivolol, Valsartan and Hydrochlorothiazide

Interventions

  • DrugNebivolol, Valsartan and Hydrochlorothiazide

    Nebivolol 5 mg (tablet), oral administration Nebivolol 10 mg (tablet), oral administration Nebivolol 20 mg (tablet), oral administration Valsartan 160 mg (tablet), oral administration Valsartan 320 mg (tablet), oral administration Hydrochlorothiazide 12.5 mg rescue medication (capsules), oral administration. Hydrochlorothiazide 25 mg rescue medication (capsules), oral administration

06

What researchers measure

Primary outcomes

  1. Adverse Event Recording

    Time frame: From Baseline to Week 53 (Visit 16)

Secondary outcomes

  1. Diastolic Blood Pressure (DBP).

    Time frame: From Baseline to Week 52 (Visit 15)

  2. Systolic Blood Pressure (SBP)

    Time frame: From Baseline to Week 52 (Visit 15)

07

Study locations

135 sites
  • Forest Investigative Site 083
    Birmingham, Alabama 35216, United States
  • Forest Investigative Site 004
    Foley, Alabama 36535, United States
  • Forest Investigative Site 038
    Gulf Shores, Alabama 36542, United States
  • Forest Investigative Site 124
    Muscle Shoals, Alabama 35662, United States
  • Forest Investigative Site 023
    Chandler, Arizona 85224, United States
  • Forest Investigative Site 073
    Goodyear, Arizona 85395, United States
  • Forest Investigative Site 100
    Green Valley, Arizona 85614, United States
  • Forest Investigative Site 117
    Mesa, Arizona 85203, United States
  • Forest Investigative Site 065
    Mesa, Arizona 85213, United States
  • Forest Investigative Site 102
    Phoenix, Arizona 85020, United States
  • Forest Investigative Site 103
    Tempe, Arizona 85282, United States
  • Forest Investigative Site 068
    Tempe, Arizona 85283, United States
  • Forest Investigative Site 066
    Jonesboro, Arkansas 72401, United States
  • Forest Investigative Site 118
    Jonesboro, Arkansas 72401, United States
  • Forest Investigative Site 135
    Carmichael, California 95608, United States
  • Forest Investigative Site 064
    Encinitas, California 92024, United States
  • Forest Investigative Site 046
    Encino, California 91436, United States
  • Forest Investigative Site 098
    Glendale, California 91205, United States
  • Forest Investigative Site 129
    Huntington Park, California 90255-5835, United States
  • Forest Investigative Site 136
    Lancaster, California 93534, United States
  • Forest Investigative Site 096
    Long Beach, California 90806, United States
  • Forest Investigative Site 015
    Los Angeles, California 90036, United States
  • Forest Investigative Site 025
    Los Angeles, California 90057, United States
  • Forest Investigative Site 101
    Mission Hills, California 91345, United States
  • Forest Investigative Site 089
    Palm Springs, California 92262, United States
  • Forest Investigative Site 116
    Pismo Beach, California 93449, United States
  • Forest Investigative Site 138
    Sacramento, California 95816, United States
  • Forest Investigative Site 132
    San Diego, California 92111, United States
  • Forest Investigative Site 061
    San Marino, California 91108, United States
  • Forest Investigative Site 095
    San Ramon, California 94583, United States
  • Forest Investigative Site 087
    Santa Ana, California 92701, United States
  • Forest Investigative Site 134
    Santa Barbara, California 93110, United States
  • Forest Investigative Site 062
    Tustin, California 92780, United States
  • Forest Investigative Site 130
    Tustin, California 92780, United States
  • Forest Investigative Site 092
    West Hills, California 91307, United States
  • Forest Investigative Site 028
    Westlake Village, California 91361, United States
  • Forest Investigative Site 006
    Northglenn, Colorado 80234, United States
  • Forest Investigative Site 030
    Cromwell, Connecticut 06416, United States
  • Forest Investigative Site 018
    Waterbury, Connecticut 06708, United States
  • Forest Investigative Site 106
    Boca Raton, Florida 33432, United States
  • Forest Investigative Site 044
    Brooksville, Florida 34601, United States
  • Forest Investigative Site 049
    Coral Gables, Florida 33134, United States
  • Forest Investigative Site 069
    Cutler Bay, Florida 33189, United States
  • Forest Investigative Site 059
    Daytona Beach, Florida 32114, United States
  • Forest Investigative Site 048
    Fort Lauderdale, Florida 33306, United States
  • Forest Investigative Site 001
    Fort Lauderdale, Florida 33308, United States
  • Forest Investigative Site 002
    Hialeah, Florida 33012, United States
  • Forest Investigative Site 022
    Miami, Florida 33143, United States
  • Forest Investigative Site 032
    Miami, Florida 33183, United States
  • Forest Investigative Site 005
    New Port Richey, Florida 34652, United States
  • Forest Investigative Site 021
    North Miami Beach, Florida 33162, United States
  • Forest Investigative Site 111
    Ocala, Florida 34471, United States
  • Forest Investigative Site 056
    Pembroke Pines, Florida 33024, United States
  • Forest Investigative Site 127
    Pembroke Pines, Florida 33026, United States
  • Forest Investigative Site 054
    Pembroke Pines, Florida 33028, United States
  • Forest Investigative Site 133
    Pembroke Pines, Florida 33029, United States
  • Forest Investigative Site 085
    Plant City, Florida 33563, United States
  • Forest Investigative Site 033
    Tampa, Florida 33606, United States
  • Forest Investigative Site 008
    Winter Haven, Florida 33880, United States
  • Forest Investigative Site 019
    Atlanta, Georgia 30338, United States
  • Forest Investigative Site 077
    Roswell, Georgia 30076, United States
  • Forest Investigative Site 126
    Arlington Heights, Illinois 60004, United States
  • Forest Investigative Site 084
    Chicago, Illinois 60607, United States
  • Forest Investigative Site 088
    Evansville, Indiana 47710, United States
  • Forest Investigative Site 108
    Newton, Kansas 67114, United States
  • Forest Investigative Site 050
    Lexington, Kentucky 40504, United States
  • Forest Investigative Site 003
    Madisonville, Kentucky 42431, United States
  • Forest Investigative Site 141
    Metairie, Louisiana 70002, United States
  • Forest Investigative Site 057
    Auburn, Maine 04210, United States
  • Forest Investigative Site 041
    Baltimore, Maryland 21209, United States
  • Forest Investigative Site 014
    Baltimore, Maryland 21236, United States
  • Forest Investigative Site 080
    Elkridge, Maryland 21075, United States
  • Forest Investigative Site 017
    Haverhill, Massachusetts 01830, United States
  • Forest Investigative Site 143
    Kalamazoo, Michigan 49009, United States
  • Forest Investigative Site 071
    Troy, Michigan 48085, United States
  • Forest Investigative Site 086
    Jackson, Mississippi 39209, United States
  • Forest Investigative Site 099
    Omaha, Nebraska 68134, United States
  • Forest Investigative Site 120
    Las Vegas, Nevada 89106, United States
  • Forest Investigative Site 119
    Las Vegas, Nevada 89119, United States
  • Forest Investigative Site 121
    Las Vegas, Nevada 89148, United States
  • Forest Investigative Site 137
    Berkeley Heights, New Jersey 07922, United States
  • Forest Investigative Site 047
    Binghamton, New York 13901, United States
  • Forest Investigative Site 072
    Rosedale, New York 11422, United States
  • Forest Investigative Site 128
    Saratoga Springs, New York 12866, United States
  • Forest Investigative Site 042
    Charlotte, North Carolina 28209, United States
  • Forest Investigative Site 139
    Greensboro, North Carolina 27401, United States
  • Forest Investigative Site 007
    Hickory, North Carolina 28602, United States
  • Forest Investigative Site 114
    Lenoir, North Carolina 28645, United States
  • Forest Investigative Site 081
    Salisbury, North Carolina 28144, United States
  • Forest Investigative Site 013
    Shelby, North Carolina 28150, United States
  • Forest Investigative Site 011
    Wilmington, North Carolina 28401, United States
  • Forest Investigative Site 036
    Winston-Salem, North Carolina 27103, United States
  • Forest Investigative Site 009
    Cincinnati, Ohio 45242, United States
  • Forest Investigative Site 125
    Kettering, Ohio 45212, United States
  • Forest Investigative Site 094
    Marion, Ohio 43302, United States
  • Forest Investigative Site 093
    Mount Gilead, Ohio 43338, United States
  • Forest Investigative Site 112
    Oklahoma City, Oklahoma 73103, United States
  • Forest Investigative Site 104
    Eugene, Oregon 97404, United States
  • Forest Investigative Site 058
    Beaver, Pennsylvania 15009, United States
  • Forest Investigative Site 131
    Penndel, Pennsylvania 19047, United States

Showing the first 100 of 135 sites.

08

References and documents

Publications

  • 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. PubMed 25492835 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01415505
Lead sponsor
Forest Laboratories
Responsible party
Sponsor
First posted
Aug 12, 2011
Start date
Aug 2011
Primary completion
Jan 2013
Completion
Apr 2013
Last update
Jun 4, 2013

Study contacts

David B Bharucha, MD, PhD, FACC
study director · Forest Laboratories

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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