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HypertensionPhase 3NCT01415505

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

A Phase 3 study testing Nebivolol, Valsartan and Hydrochlorothiazide in people with Hypertension, run by Forest Laboratories at 135 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
Nebivolol, Valsartan and Hydrochlorothiazide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
812 participants
Where
135 sitesUnited States
Study dates
Aug 2011to Apr 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

135 sites in 1 country.

135 sites in 1 country

United States135 sites

  • Forest Investigative Site 110

    Alexandria, Virginia, 22304

  • Forest Investigative Site 016

    Arlington, Texas, 76012

  • Forest Investigative Site 126

    Arlington Heights, Illinois, 60004

  • Forest Investigative Site 019

    Atlanta, Georgia, 30338

  • Forest Investigative Site 057

    Auburn, Maine, 04210

  • Forest Investigative Site 041

    Baltimore, Maryland, 21209

  • Forest Investigative Site 014

    Baltimore, Maryland, 21236

  • Forest Investigative Site 058

    Beaver, Pennsylvania, 15009

  • Forest Investigative Site 137

    Berkeley Heights, New Jersey, 07922

  • Forest Investigative Site 047

    Binghamton, New York, 13901

  • Forest Investigative Site 083

    Birmingham, Alabama, 35216

  • Forest Investigative Site 106

    Boca Raton, Florida, 33432

  • Forest Investigative Site 113

    Bristol, Tennessee, 37620

  • Forest Investigative Site 044

    Brooksville, Florida, 34601

  • Forest Investigative Site 074

    Burke, Virginia, 22015

  • Forest Investigative Site 135

    Carmichael, California, 95608

  • Forest Investigative Site 063

    Carrollton, Texas, 75006

  • Forest Investigative Site 023

    Chandler, Arizona, 85224

  • Forest Investigative Site 012

    Charleston, South Carolina, 29407

  • Forest Investigative Site 042

    Charlotte, North Carolina, 28209

  • Forest Investigative Site 084

    Chicago, Illinois, 60607

  • Forest Investigative Site 009

    Cincinnati, Ohio, 45242

  • Forest Investigative Site 040

    Columbia, South Carolina, 29204

  • Forest Investigative Site 049

    Coral Gables, Florida, 33134

  • Forest Investigative Site 030

    Cromwell, Connecticut, 06416

  • Forest Investigative Site 069

    Cutler Bay, Florida, 33189

  • Forest Investigative Site 123

    Dallas, Texas, 75251

  • Forest Investigative Site 059

    Daytona Beach, Florida, 32114

  • Forest Investigative Site 080

    Elkridge, Maryland, 21075

  • Forest Investigative Site 064

    Encinitas, California, 92024

  • Forest Investigative Site 046

    Encino, California, 91436

  • Forest Investigative Site 104

    Eugene, Oregon, 97404

  • Forest Investigative Site 088

    Evansville, Indiana, 47710

  • Forest Investigative Site 034

    Fayetteville, Tennessee, 37334

  • Forest Investigative Site 004

    Foley, Alabama, 36535

  • Forest Investigative Site 048

    Fort Lauderdale, Florida, 33306

  • Forest Investigative Site 001

    Fort Lauderdale, Florida, 33308

  • Forest Investigative Site 079

    Fort Worth, Texas, 76135

  • Forest Investigative Site 070

    Franklin, Tennessee, 37067

  • Forest Investigative Site 098

    Glendale, California, 91205

  • Forest Investigative Site 073

    Goodyear, Arizona, 85395

  • Forest Investigative Site 100

    Green Valley, Arizona, 85614

  • Forest Investigative Site 139

    Greensboro, North Carolina, 27401

  • Forest Investigative Site 060

    Greer, South Carolina, 29651

  • Forest Investigative Site 038

    Gulf Shores, Alabama, 36542

  • Forest Investigative Site 017

    Haverhill, Massachusetts, 01830

  • Forest Investigative Site 002

    Hialeah, Florida, 33012

  • Forest Investigative Site 007

    Hickory, North Carolina, 28602

  • Forest Investigative Site 052

    Houston, Texas, 77079

  • Forest Investigative Site 024

    Houston, Texas, 77081

  • Forest Investigative Site 026

    Houston, Texas, 77081

  • Forest Investigative Site 027

    Houston, Texas, 77081

  • Forest Investigative Site 129

    Huntington Park, California, 90255-5835

  • Forest Investigative Site 086

    Jackson, Mississippi, 39209

  • Forest Investigative Site 066

    Jonesboro, Arkansas, 72401

  • Forest Investigative Site 118

    Jonesboro, Arkansas, 72401

  • Forest Investigative Site 143

    Kalamazoo, Michigan, 49009

  • Forest Investigative Site 125

    Kettering, Ohio, 45212

  • Forest Investigative Site 136

    Lancaster, California, 93534

  • Forest Investigative Site 120

    Las Vegas, Nevada, 89106

  • Forest Investigative Site 119

    Las Vegas, Nevada, 89119

  • Forest Investigative Site 121

    Las Vegas, Nevada, 89148

  • Forest Investigative Site 114

    Lenoir, North Carolina, 28645

  • Forest Investigative Site 050

    Lexington, Kentucky, 40504

  • Forest Investigative Site 096

    Long Beach, California, 90806

  • Forest Investigative Site 015

    Los Angeles, California, 90036

  • Forest Investigative Site 025

    Los Angeles, California, 90057

  • Forest Investigative Site 003

    Madisonville, Kentucky, 42431

  • Forest Investigative Site 067

    Manassas, Virginia, 20110

  • Forest Investigative Site 094

    Marion, Ohio, 43302

  • Forest Investigative Site 117

    Mesa, Arizona, 85203

  • Forest Investigative Site 065

    Mesa, Arizona, 85213

  • Forest Investigative Site 141

    Metairie, Louisiana, 70002

  • Forest Investigative Site 022

    Miami, Florida, 33143

  • Forest Investigative Site 032

    Miami, Florida, 33183

  • Forest Investigative Site 101

    Mission Hills, California, 91345

  • Forest Investigative Site 093

    Mount Gilead, Ohio, 43338

  • Forest Investigative Site 035

    Mt. Pleasant, South Carolina, 29464

  • Forest Investigative Site 082

    Mt. Pleasant, South Carolina, 29464

  • Forest Investigative Site 124

    Muscle Shoals, Alabama, 35662

  • Forest Investigative Site 005

    New Port Richey, Florida, 34652

  • Forest Investigative Site 108

    Newton, Kansas, 67114

  • Forest Investigative Site 037

    Norfolk, Virginia, 23507

  • Forest Investigative Site 021

    North Miami Beach, Florida, 33162

  • Forest Investigative Site 006

    Northglenn, Colorado, 80234

  • Forest Investigative Site 111

    Ocala, Florida, 34471

  • Forest Investigative Site 112

    Oklahoma City, Oklahoma, 73103

  • Forest Investigative Site 099

    Omaha, Nebraska, 68134

  • Forest Investigative Site 089

    Palm Springs, California, 92262

  • Forest Investigative Site 056

    Pembroke Pines, Florida, 33024

  • Forest Investigative Site 127

    Pembroke Pines, Florida, 33026

  • Forest Investigative Site 054

    Pembroke Pines, Florida, 33028

  • Forest Investigative Site 133

    Pembroke Pines, Florida, 33029

  • Forest Investigative Site 131

    Penndel, Pennsylvania, 19047

  • Forest Investigative Site 105

    Philadelphia, Pennsylvania, 19146

  • Forest Investigative Site 102

    Phoenix, Arizona, 85020

  • Forest Investigative Site 116

    Pismo Beach, California, 93449

  • Forest Investigative Site 140

    Plano, Texas, 75075

  • Forest Investigative Site 085

    Plant City, Florida, 33563

  • Forest Investigative Site 072

    Rosedale, New York, 11422

  • Forest Investigative Site 077

    Roswell, Georgia, 30076

  • Forest Investigative Site 138

    Sacramento, California, 95816

  • Forest Investigative Site 081

    Salisbury, North Carolina, 28144

  • Forest Investigative Site 090

    Salt Lake City, Utah, 84107

  • Forest Investigative Site 053

    Salt Lake City, Utah, 84124

  • Forest Investigative Site 091

    San Angelo, Texas, 76904

  • Forest Investigative Site 055

    San Antonio, Texas, 78209

  • Forest Investigative Site 115

    San Antonio, Texas, 78229

  • Forest Investigative Site 132

    San Diego, California, 92111

  • Forest Investigative Site 061

    San Marino, California, 91108

  • Forest Investigative Site 095

    San Ramon, California, 94583

  • Forest Investigative Site 087

    Santa Ana, California, 92701

  • Forest Investigative Site 134

    Santa Barbara, California, 93110

  • Forest Investigative Site 128

    Saratoga Springs, New York, 12866

  • Forest Investigative Site 013

    Shelby, North Carolina, 28150

  • Forest Investigative Site 142

    Simpsonville, South Carolina, 29681

  • Forest Investigative Site 051

    St. George, Utah, 84790

  • Forest Investigative Site 122

    Suffolk, Virginia, 23435

  • Forest Investigative Site 078

    Sugar Land, Texas, 77479

  • Forest Investigative Site 045

    Summerville, South Carolina, 29485

  • Forest Investigative Site 107

    Tacoma, Washington, 98405

  • Forest Investigative Site 033

    Tampa, Florida, 33606

  • Forest Investigative Site 103

    Tempe, Arizona, 85282

  • Forest Investigative Site 068

    Tempe, Arizona, 85283

  • Forest Investigative Site 071

    Troy, Michigan, 48085

  • Forest Investigative Site 062

    Tustin, California, 92780

  • Forest Investigative Site 130

    Tustin, California, 92780

  • Forest Investigative Site 039

    Upper Saint Clair, Pennsylvania, 15241

  • Forest Investigative Site 010

    Virginia Beach, Virginia, 23454

  • Forest Investigative Site 018

    Waterbury, Connecticut, 06708

  • Forest Investigative Site 092

    West Hills, California, 91307

  • Forest Investigative Site 028

    Westlake Village, California, 91361

  • Forest Investigative Site 011

    Wilmington, North Carolina, 28401

  • Forest Investigative Site 036

    Winston-Salem, North Carolina, 27103

  • Forest Investigative Site 008

    Winter Haven, Florida, 33880

Other trials in United States

About this study

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

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
Being tested
Nebivolol, Valsartan and Hydrochlorothiazide
Keywords
Stage 1, Stage 2, Hypertension, 1 year open label safety study
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nebivolol, Valsartan and HydrochlorothiazideDrug

    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

Study groups in NCT01415505
Study groupRoleWhat they receive
1OtherNebivolol and Valsartan free tablet combination
Receives: Drug: Nebivolol, Valsartan and Hydrochlorothiazide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Event Recording

    Measured: From Baseline to Week 53 (Visit 16)

Secondary outcomes (2)

  1. Diastolic Blood Pressure (DBP).

    Measured: From Baseline to Week 52 (Visit 15)

  2. Systolic Blood Pressure (SBP)

    Measured: From Baseline to Week 52 (Visit 15)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionJan 2013
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
812 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01415505
Sponsor's protocol ID
NAC-MD-02
Status last verified
May 2013
First submitted
10 Aug 2011
Last updated
4 Jun 2013
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nebivolol, Valsartan and Hydrochlorothiazide in people with Hypertension, run by Forest Laboratories at 135 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 135 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Event Recording (time frame: From Baseline to Week 53 (Visit 16)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01415505, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2013; AzTrials last refreshed its copy on 7 Nov 2026.

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