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

NCT01415505 | Completed Phase 3

• 1 other identifier: NAC-MD-02
• Study Type: interventional
• Target: 812
• Locations: 1 country
• Sites: 135

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.

Conditions

Hypertension

Keywords

Stage 1; Stage 2; Hypertension; 1 year open label safety study

Outcome Measures

Primary Outcomes (1)

• Adverse Event Recording

  From Baseline to Week 53 (Visit 16)

Secondary Outcomes (2)

• Diastolic Blood Pressure (DBP).

  From Baseline to Week 52 (Visit 15)

• Systolic Blood Pressure (SBP)

  From Baseline to Week 52 (Visit 15)

Study Arms (1)

1

OTHER

Nebivolol and Valsartan free tablet combination

Drug: Nebivolol, Valsartan and Hydrochlorothiazide

Interventions

Nebivolol, Valsartan and Hydrochlorothiazide DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (135)

Forest Investigative Site 083

Birmingham, Alabama, 35216, United States

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Forest Investigative Site 004

Foley, Alabama, 36535, United States

Location

Forest Investigative Site 038

Gulf Shores, Alabama, 36542, United States

Location

Forest Investigative Site 124

Muscle Shoals, Alabama, 35662, United States

Location

Forest Investigative Site 023

Chandler, Arizona, 85224, United States

Location

Forest Investigative Site 073

Goodyear, Arizona, 85395, United States

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Forest Investigative Site 100

Green Valley, Arizona, 85614, United States

Location

Forest Investigative Site 117

Mesa, Arizona, 85203, United States

Location

Forest Investigative Site 065

Mesa, Arizona, 85213, United States

Location

Forest Investigative Site 102

Phoenix, Arizona, 85020, United States

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Forest Investigative Site 103

Tempe, Arizona, 85282, United States

Location

Forest Investigative Site 068

Tempe, Arizona, 85283, United States

Location

Forest Investigative Site 066

Jonesboro, Arkansas, 72401, United States

Location

Forest Investigative Site 118

Jonesboro, Arkansas, 72401, United States

Location

Forest Investigative Site 135

Carmichael, California, 95608, United States

Location

Forest Investigative Site 064

Encinitas, California, 92024, United States

Location

Forest Investigative Site 046

Encino, California, 91436, United States

Location

Forest Investigative Site 098

Glendale, California, 91205, United States

Location

Forest Investigative Site 129

Huntington Park, California, 90255-5835, United States

Location

Forest Investigative Site 136

Lancaster, California, 93534, United States

Location

Forest Investigative Site 096

Long Beach, California, 90806, United States

Location

Forest Investigative Site 015

Los Angeles, California, 90036, United States

Location

Forest Investigative Site 025

Los Angeles, California, 90057, United States

Location

Forest Investigative Site 101

Mission Hills, California, 91345, United States

Location

Forest Investigative Site 089

Palm Springs, California, 92262, United States

Location

Forest Investigative Site 116

Pismo Beach, California, 93449, United States

Location

Forest Investigative Site 138

Sacramento, California, 95816, United States

Location

Forest Investigative Site 132

San Diego, California, 92111, United States

Location

Forest Investigative Site 061

San Marino, California, 91108, United States

Location

Forest Investigative Site 095

San Ramon, California, 94583, United States

Location

Forest Investigative Site 087

Santa Ana, California, 92701, United States

Location

Forest Investigative Site 134

Santa Barbara, California, 93110, United States

Location

Forest Investigative Site 062

Tustin, California, 92780, United States

Location

Forest Investigative Site 130

Tustin, California, 92780, United States

Location

Forest Investigative Site 092

West Hills, California, 91307, United States

Location

Forest Investigative Site 028

Westlake Village, California, 91361, United States

Location

Forest Investigative Site 006

Northglenn, Colorado, 80234, United States

Location

Forest Investigative Site 030

Cromwell, Connecticut, 06416, United States

Location

Forest Investigative Site 018

Waterbury, Connecticut, 06708, United States

Location

Forest Investigative Site 106

Boca Raton, Florida, 33432, United States

Location

Forest Investigative Site 044

Brooksville, Florida, 34601, United States

Location

Forest Investigative Site 049

Coral Gables, Florida, 33134, United States

Location

Forest Investigative Site 069

Cutler Bay, Florida, 33189, United States

Location

Forest Investigative Site 059

Daytona Beach, Florida, 32114, United States

Location

Forest Investigative Site 048

Fort Lauderdale, Florida, 33306, United States

Location

Forest Investigative Site 001

Fort Lauderdale, Florida, 33308, United States

Location

Forest Investigative Site 002

Hialeah, Florida, 33012, United States

Location

Forest Investigative Site 022

Miami, Florida, 33143, United States

Location

Forest Investigative Site 032

Miami, Florida, 33183, United States

Location

Forest Investigative Site 005

New Port Richey, Florida, 34652, United States

Location

Forest Investigative Site 021

North Miami Beach, Florida, 33162, United States

Location

Forest Investigative Site 111

Ocala, Florida, 34471, United States

Location

Forest Investigative Site 056

Pembroke Pines, Florida, 33024, United States

Location

Forest Investigative Site 127

Pembroke Pines, Florida, 33026, United States

Location

Forest Investigative Site 054

Pembroke Pines, Florida, 33028, United States

Location

Forest Investigative Site 133

Pembroke Pines, Florida, 33029, United States

Location

Forest Investigative Site 085

Plant City, Florida, 33563, United States

Location

Forest Investigative Site 033

Tampa, Florida, 33606, United States

Location

Forest Investigative Site 008

Winter Haven, Florida, 33880, United States

Location

Forest Investigative Site 019

Atlanta, Georgia, 30338, United States

Location

Forest Investigative Site 077

Roswell, Georgia, 30076, United States

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Forest Investigative Site 126

Arlington Heights, Illinois, 60004, United States

Location

Forest Investigative Site 084

Chicago, Illinois, 60607, United States

Location

Forest Investigative Site 088

Evansville, Indiana, 47710, United States

Location

Forest Investigative Site 108

Newton, Kansas, 67114, United States

Location

Forest Investigative Site 050

Lexington, Kentucky, 40504, United States

Location

Forest Investigative Site 003

Madisonville, Kentucky, 42431, United States

Location

Forest Investigative Site 141

Metairie, Louisiana, 70002, United States

Location

Forest Investigative Site 057

Auburn, Maine, 04210, United States

Location

Forest Investigative Site 041

Baltimore, Maryland, 21209, United States

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Forest Investigative Site 014

Baltimore, Maryland, 21236, United States

Location

Forest Investigative Site 080

Elkridge, Maryland, 21075, United States

Location

Forest Investigative Site 017

Haverhill, Massachusetts, 01830, United States

Location

Forest Investigative Site 143

Kalamazoo, Michigan, 49009, United States

Location

Forest Investigative Site 071

Troy, Michigan, 48085, United States

Location

Forest Investigative Site 086

Jackson, Mississippi, 39209, United States

Location

Forest Investigative Site 099

Omaha, Nebraska, 68134, United States

Location

Forest Investigative Site 120

Las Vegas, Nevada, 89106, United States

Location

Forest Investigative Site 119

Las Vegas, Nevada, 89119, United States

Location

Forest Investigative Site 121

Las Vegas, Nevada, 89148, United States

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Forest Investigative Site 137

Berkeley Heights, New Jersey, 07922, United States

Location

Forest Investigative Site 047

Binghamton, New York, 13901, United States

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Forest Investigative Site 072

Rosedale, New York, 11422, United States

Location

Forest Investigative Site 128

Saratoga Springs, New York, 12866, United States

Location

Forest Investigative Site 042

Charlotte, North Carolina, 28209, United States

Location

Forest Investigative Site 139

Greensboro, North Carolina, 27401, United States

Location

Forest Investigative Site 007

Hickory, North Carolina, 28602, United States

Location

Forest Investigative Site 114

Lenoir, North Carolina, 28645, United States

Location

Forest Investigative Site 081

Salisbury, North Carolina, 28144, United States

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Forest Investigative Site 013

Shelby, North Carolina, 28150, United States

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Forest Investigative Site 011

Wilmington, North Carolina, 28401, United States

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Forest Investigative Site 036

Winston-Salem, North Carolina, 27103, United States

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Forest Investigative Site 009

Cincinnati, Ohio, 45242, United States

Location

Forest Investigative Site 125

Kettering, Ohio, 45212, United States

Location

Forest Investigative Site 094

Marion, Ohio, 43302, United States

Location

Forest Investigative Site 093

Mount Gilead, Ohio, 43338, United States

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Forest Investigative Site 112

Oklahoma City, Oklahoma, 73103, United States

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Forest Investigative Site 104

Eugene, Oregon, 97404, United States

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Forest Investigative Site 058

Beaver, Pennsylvania, 15009, United States

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Forest Investigative Site 131

Penndel, Pennsylvania, 19047, United States

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Forest Investigative Site 105

Philadelphia, Pennsylvania, 19146, United States

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Forest Investigative Site 039

Upper Saint Clair, Pennsylvania, 15241, United States

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Forest Investigative Site 012

Charleston, South Carolina, 29407, United States

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Forest Investigative Site 040

Columbia, South Carolina, 29204, United States

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Forest Investigative Site 060

Greer, South Carolina, 29651, United States

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Forest Investigative Site 035

Mt. Pleasant, South Carolina, 29464, United States

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Forest Investigative Site 082

Mt. Pleasant, South Carolina, 29464, United States

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Forest Investigative Site 142

Simpsonville, South Carolina, 29681, United States

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Forest Investigative Site 045

Summerville, South Carolina, 29485, United States

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Forest Investigative Site 113

Bristol, Tennessee, 37620, United States

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Forest Investigative Site 034

Fayetteville, Tennessee, 37334, United States

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Forest Investigative Site 070

Franklin, Tennessee, 37067, United States

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Forest Investigative Site 016

Arlington, Texas, 76012, United States

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Forest Investigative Site 063

Carrollton, Texas, 75006, United States

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Forest Investigative Site 123

Dallas, Texas, 75251, United States

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Forest Investigative Site 079

Fort Worth, Texas, 76135, United States

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Forest Investigative Site 052

Houston, Texas, 77079, United States

Location

Forest Investigative Site 024

Houston, Texas, 77081, United States

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Forest Investigative Site 026

Houston, Texas, 77081, United States

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Forest Investigative Site 027

Houston, Texas, 77081, United States

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Forest Investigative Site 140

Plano, Texas, 75075, United States

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Forest Investigative Site 091

San Angelo, Texas, 76904, United States

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Forest Investigative Site 055

San Antonio, Texas, 78209, United States

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Forest Investigative Site 115

San Antonio, Texas, 78229, United States

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Forest Investigative Site 078

Sugar Land, Texas, 77479, United States

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Forest Investigative Site 090

Salt Lake City, Utah, 84107, United States

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Forest Investigative Site 053

Salt Lake City, Utah, 84124, United States

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Forest Investigative Site 051

St. George, Utah, 84790, United States

Location

Forest Investigative Site 110

Alexandria, Virginia, 22304, United States

Location

Forest Investigative Site 074

Burke, Virginia, 22015, United States

Location

Forest Investigative Site 067

Manassas, Virginia, 20110, United States

Location

Forest Investigative Site 037

Norfolk, Virginia, 23507, United States

Location

Forest Investigative Site 122

Suffolk, Virginia, 23435, United States

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Forest Investigative Site 010

Virginia Beach, Virginia, 23454, United States

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Forest Investigative Site 107

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

• 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.

  PMID: 25492835 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Nebivolol; Valsartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tetrazoles; Azoles; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides

Study Officials

• David B Bharucha, MD, PhD, FACC

  Forest Laboratories

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: August 12, 2011
• Study Start: August 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 4, 2013

Record last verified: 2013-05

Locations

US (135)