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

May 31, 2013 updated by: Forest Laboratories

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

812

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Forest Investigative Site 083
      • Foley, Alabama, United States, 36535
        • Forest Investigative Site 004
      • Gulf Shores, Alabama, United States, 36542
        • Forest Investigative Site 038
      • Muscle Shoals, Alabama, United States, 35662
        • Forest Investigative Site 124
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Forest Investigative Site 023
      • Goodyear, Arizona, United States, 85395
        • Forest Investigative Site 073
      • Green Valley, Arizona, United States, 85614
        • Forest Investigative Site 100
      • Mesa, Arizona, United States, 85203
        • Forest Investigative Site 117
      • Mesa, Arizona, United States, 85213
        • Forest Investigative Site 065
      • Phoenix, Arizona, United States, 85020
        • Forest Investigative Site 102
      • Tempe, Arizona, United States, 85282
        • Forest Investigative Site 103
      • Tempe, Arizona, United States, 85283
        • Forest Investigative Site 068
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Forest Investigative Site 066
      • Jonesboro, Arkansas, United States, 72401
        • Forest Investigative Site 118
    • California
      • Carmichael, California, United States, 95608
        • Forest Investigative Site 135
      • Encinitas, California, United States, 92024
        • Forest Investigative Site 064
      • Encino, California, United States, 91436
        • Forest Investigative Site 046
      • Glendale, California, United States, 91205
        • Forest Investigative Site 098
      • Huntington Park, California, United States, 90255-5835
        • Forest Investigative Site 129
      • Lancaster, California, United States, 93534
        • Forest Investigative Site 136
      • Long Beach, California, United States, 90806
        • Forest Investigative Site 096
      • Los Angeles, California, United States, 90036
        • Forest Investigative Site 015
      • Los Angeles, California, United States, 90057
        • Forest Investigative Site 025
      • Mission Hills, California, United States, 91345
        • Forest Investigative Site 101
      • Palm Springs, California, United States, 92262
        • Forest Investigative Site 089
      • Pismo Beach, California, United States, 93449
        • Forest Investigative Site 116
      • Sacramento, California, United States, 95816
        • Forest Investigative Site 138
      • San Diego, California, United States, 92111
        • Forest Investigative Site 132
      • San Marino, California, United States, 91108
        • Forest Investigative Site 061
      • San Ramon, California, United States, 94583
        • Forest Investigative Site 095
      • Santa Ana, California, United States, 92701
        • Forest Investigative Site 087
      • Santa Barbara, California, United States, 93110
        • Forest Investigative Site 134
      • Tustin, California, United States, 92780
        • Forest Investigative Site 062
      • Tustin, California, United States, 92780
        • Forest Investigative Site 130
      • West Hills, California, United States, 91307
        • Forest Investigative Site 092
      • Westlake Village, California, United States, 91361
        • Forest Investigative Site 028
    • Colorado
      • Northglenn, Colorado, United States, 80234
        • Forest Investigative Site 006
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Forest Investigative Site 030
      • Waterbury, Connecticut, United States, 06708
        • Forest Investigative Site 018
    • Florida
      • Boca Raton, Florida, United States, 33432
        • Forest Investigative Site 106
      • Brooksville, Florida, United States, 34601
        • Forest Investigative Site 044
      • Coral Gables, Florida, United States, 33134
        • Forest Investigative Site 049
      • Cutler Bay, Florida, United States, 33189
        • Forest Investigative Site 069
      • Daytona Beach, Florida, United States, 32114
        • Forest Investigative Site 059
      • Fort Lauderdale, Florida, United States, 33306
        • Forest Investigative Site 048
      • Fort Lauderdale, Florida, United States, 33308
        • Forest Investigative Site 001
      • Hialeah, Florida, United States, 33012
        • Forest Investigative Site 002
      • Miami, Florida, United States, 33143
        • Forest Investigative Site 022
      • Miami, Florida, United States, 33183
        • Forest Investigative Site 032
      • New Port Richey, Florida, United States, 34652
        • Forest Investigative Site 005
      • North Miami Beach, Florida, United States, 33162
        • Forest Investigative Site 021
      • Ocala, Florida, United States, 34471
        • Forest Investigative Site 111
      • Pembroke Pines, Florida, United States, 33024
        • Forest Investigative Site 056
      • Pembroke Pines, Florida, United States, 33026
        • Forest Investigative Site 127
      • Pembroke Pines, Florida, United States, 33028
        • Forest Investigative Site 054
      • Pembroke Pines, Florida, United States, 33029
        • Forest Investigative Site 133
      • Plant City, Florida, United States, 33563
        • Forest Investigative Site 085
      • Tampa, Florida, United States, 33606
        • Forest Investigative Site 033
      • Winter Haven, Florida, United States, 33880
        • Forest Investigative Site 008
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Forest Investigative Site 019
      • Roswell, Georgia, United States, 30076
        • Forest Investigative Site 077
    • Illinois
      • Arlington Heights, Illinois, United States, 60004
        • Forest Investigative Site 126
      • Chicago, Illinois, United States, 60607
        • Forest Investigative Site 084
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Forest Investigative Site 088
    • Kansas
      • Newton, Kansas, United States, 67114
        • Forest Investigative Site 108
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Forest Investigative Site 050
      • Madisonville, Kentucky, United States, 42431
        • Forest Investigative Site 003
    • Louisiana
      • Metairie, Louisiana, United States, 70002
        • Forest Investigative Site 141
    • Maine
      • Auburn, Maine, United States, 04210
        • Forest Investigative Site 057
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Forest Investigative Site 041
      • Baltimore, Maryland, United States, 21236
        • Forest Investigative Site 014
      • Elkridge, Maryland, United States, 21075
        • Forest Investigative Site 080
    • Massachusetts
      • Haverhill, Massachusetts, United States, 01830
        • Forest Investigative Site 017
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Forest Investigative Site 143
      • Troy, Michigan, United States, 48085
        • Forest Investigative Site 071
    • Mississippi
      • Jackson, Mississippi, United States, 39209
        • Forest Investigative Site 086
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Forest Investigative Site 099
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Forest Investigative Site 120
      • Las Vegas, Nevada, United States, 89119
        • Forest Investigative Site 119
      • Las Vegas, Nevada, United States, 89148
        • Forest Investigative Site 121
    • New Jersey
      • Berkeley Heights, New Jersey, United States, 07922
        • Forest Investigative Site 137
    • New York
      • Binghamton, New York, United States, 13901
        • Forest Investigative Site 047
      • Rosedale, New York, United States, 11422
        • Forest Investigative Site 072
      • Saratoga Springs, New York, United States, 12866
        • Forest Investigative Site 128
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Forest Investigative Site 042
      • Greensboro, North Carolina, United States, 27401
        • Forest Investigative Site 139
      • Hickory, North Carolina, United States, 28602
        • Forest Investigative Site 007
      • Lenoir, North Carolina, United States, 28645
        • Forest Investigative Site 114
      • Salisbury, North Carolina, United States, 28144
        • Forest Investigative Site 081
      • Shelby, North Carolina, United States, 28150
        • Forest Investigative Site 013
      • Wilmington, North Carolina, United States, 28401
        • Forest Investigative Site 011
      • Winston-Salem, North Carolina, United States, 27103
        • Forest Investigative Site 036
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Forest Investigative Site 009
      • Kettering, Ohio, United States, 45212
        • Forest Investigative Site 125
      • Marion, Ohio, United States, 43302
        • Forest Investigative Site 094
      • Mount Gilead, Ohio, United States, 43338
        • Forest Investigative Site 093
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Forest Investigative Site 112
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Forest Investigative Site 104
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Forest Investigative Site 058
      • Penndel, Pennsylvania, United States, 19047
        • Forest Investigative Site 131
      • Philadelphia, Pennsylvania, United States, 19146
        • Forest Investigative Site 105
      • Upper St. Clair, Pennsylvania, United States, 15241
        • Forest Investigative Site 039
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Forest Investigative Site 012
      • Columbia, South Carolina, United States, 29204
        • Forest Investigative Site 040
      • Greer, South Carolina, United States, 29651
        • Forest Investigative Site 060
      • Mt. Pleasant, South Carolina, United States, 29464
        • Forest Investigative Site 035
      • Mt. Pleasant, South Carolina, United States, 29464
        • Forest Investigative Site 082
      • Simpsonville, South Carolina, United States, 29681
        • Forest Investigative Site 142
      • Summerville, South Carolina, United States, 29485
        • Forest Investigative Site 045
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Forest Investigative Site 113
      • Fayetteville, Tennessee, United States, 37334
        • Forest Investigative Site 034
      • Franklin, Tennessee, United States, 37067
        • Forest Investigative Site 070
    • Texas
      • Arlington, Texas, United States, 76012
        • Forest Investigative Site 016
      • Carrollton, Texas, United States, 75006
        • Forest Investigative Site 063
      • Dallas, Texas, United States, 75251
        • Forest Investigative Site 123
      • Fort Worth, Texas, United States, 76135
        • Forest Investigative Site 079
      • Houston, Texas, United States, 77079
        • Forest Investigative Site 052
      • Houston, Texas, United States, 77081
        • Forest Investigative Site 024
      • Houston, Texas, United States, 77081
        • Forest Investigative Site 026
      • Houston, Texas, United States, 77081
        • Forest Investigative Site 027
      • Plano, Texas, United States, 75075
        • Forest Investigative Site 140
      • San Angelo, Texas, United States, 76904
        • Forest Investigative Site 091
      • San Antonio, Texas, United States, 78209
        • Forest Investigative Site 055
      • San Antonio, Texas, United States, 78229
        • Forest Investigative Site 115
      • Sugar Land, Texas, United States, 77479
        • Forest Investigative Site 078
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Forest Investigative Site 090
      • Salt Lake City, Utah, United States, 84124
        • Forest Investigative Site 053
      • St. George, Utah, United States, 84790
        • Forest Investigative Site 051
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Forest Investigative Site 110
      • Burke, Virginia, United States, 22015
        • Forest Investigative Site 074
      • Manassas, Virginia, United States, 20110
        • Forest Investigative Site 067
      • Norfolk, Virginia, United States, 23507
        • Forest Investigative Site 037
      • Suffolk, Virginia, United States, 23435
        • Forest Investigative Site 122
      • Virginia Beach, Virginia, United States, 23454
        • Forest Investigative Site 010
    • Washington
      • Tacoma, Washington, United States, 98405
        • Forest Investigative Site 107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Nebivolol and Valsartan free tablet combination
Drug: Nebivolol, 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Event Recording
Time Frame: From Baseline to Week 53 (Visit 16)
From Baseline to Week 53 (Visit 16)

Secondary Outcome Measures

Outcome Measure
Time Frame
Diastolic Blood Pressure (DBP).
Time Frame: From Baseline to Week 52 (Visit 15)
From Baseline to Week 52 (Visit 15)
Systolic Blood Pressure (SBP)
Time Frame: From Baseline to Week 52 (Visit 15)
From Baseline to Week 52 (Visit 15)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Investigators

  • Study Director: David B Bharucha, MD, PhD, FACC, Forest Laboratories

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

August 10, 2011

First Submitted That Met QC Criteria

August 11, 2011

First Posted (Estimate)

August 12, 2011

Study Record Updates

Last Update Posted (Estimate)

June 4, 2013

Last Update Submitted That Met QC Criteria

May 31, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAC-MD-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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