Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction

NCT ID: NCT02929329

Last Updated: 2021-11-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

8256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-06

Study Completion Date

2020-09-14

Brief Summary

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The purpose of this study is to determine if treatment with omecamtiv mecarbil when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in adults with chronic heart failure with reduced ejection fraction (HFrEF).

Detailed Description

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This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Omecamtiv Mecarbil

Participants received oral omecamtiv mecarbil (OM) twice daily in addition to standard heart failure therapy. The starting dose of OM was 25 mg; At week 4, participants with week 2 OM predose plasma concentrations \< 200 ng/mL had their dose increased to 50 mg BID; participants with week 2 predose plasma concentrations ≥ 200 and \< 300 ng/mL had their dose increased to 37.5 mg BID and participants with week 2 predose plasma concentrations ≥ 300 ng/mL and \< 1000 ng/mL maintained a 25 mg BID dosing regimen.

Group Type EXPERIMENTAL

Omecamtiv Mecarbil

Intervention Type DRUG

Omecamtiv mecarbil tablets for oral administration

Standard of Care

Intervention Type DRUG

Participants were required to be optimally managed with standard of care therapies for chronic HF (eg, beta blockers, renin angiotensin aldosterone system inhibitors), consistent with regional clinical practice guidelines, unless contraindicated.

Placebo

Participants received matching placebo tablets twice a day in addition to standard heart failure therapy.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo tablets

Standard of Care

Intervention Type DRUG

Participants were required to be optimally managed with standard of care therapies for chronic HF (eg, beta blockers, renin angiotensin aldosterone system inhibitors), consistent with regional clinical practice guidelines, unless contraindicated.

Interventions

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Omecamtiv Mecarbil

Omecamtiv mecarbil tablets for oral administration

Intervention Type DRUG

Placebo

Matching placebo tablets

Intervention Type DRUG

Standard of Care

Participants were required to be optimally managed with standard of care therapies for chronic HF (eg, beta blockers, renin angiotensin aldosterone system inhibitors), consistent with regional clinical practice guidelines, unless contraindicated.

Intervention Type DRUG

Other Intervention Names

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AMG 423

Eligibility Criteria

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Inclusion Criteria

* Subject has provided informed consent
* Male or female, ≥ 18 to ≤ 85 years
* History of chronic heart failure (HF), defined as requiring treatment for HF for a minimum of 30 days before randomization
* Left ventricle ejection fraction (LVEF) ≤ 35%, per subjects most recent medical record, within 12 months prior to screening.
* New York Heart Association (NYHA) class II to IV at most recent screening assessment.
* Managed with HF standard of care (SoC) therapies consistent with regional clinical practice guidelines according to investigator judgment of subject's clinical status
* Current hospitalization with primary reason of HF OR one of the following events within 1 year of screening: hospitalization with primary reason of HF; urgent visit to emergency department (ED) with primary reason of HF.
* Elevated B-type natriuretic peptide (BNP) or n-terminal-prohormone brain natriuretic peptide (NT-proBNP)

Exclusion Criteria

* Currently receiving treatment in another investigational device or drug study, or \< 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
* Malignancy within 5 years prior to randomization with the following exceptions: localized basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, stage 1 prostate carcinoma, breast ductal carcinoma in situ.
* Subject has known sensitivity to any of the products or components to be administered during testing
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cytokinetics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Oak Ridge, Tennessee, United States

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Powell, Tennessee, United States

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Tullahoma, Tennessee, United States

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Amarillo, Texas, United States

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Fort Payne, Alabama, United States

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Scottsboro, Alabama, United States

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Tuscumbia, Alabama, United States

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Gilbert, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Beverly Hills, California, United States

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Burbank, California, United States

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Carmichael, California, United States

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Fresno, California, United States

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Huntington Beach, California, United States

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Loma Linda, California, United States

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Long Beach, California, United States

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Long Beach, California, United States

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Los Alamitos, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Mission Viejo, California, United States

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Newport Beach, California, United States

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Northridge, California, United States

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Redondo Beach, California, United States

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Riverside, California, United States

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Sacramento, California, United States

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San Francisco, California, United States

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San Pedro, California, United States

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Santa Ana, California, United States

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Santa Rosa, California, United States

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Stanford, California, United States

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Stockton, California, United States

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Torrance, California, United States

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Torrance, California, United States

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Tustin, California, United States

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Ventura, California, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Littleton, Colorado, United States

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Wheat Ridge, Colorado, United States

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Hartford, Connecticut, United States

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Stamford, Connecticut, United States

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Waterbury, Connecticut, United States

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West Haven, Connecticut, United States

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Newark, Delaware, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Altamonte Springs, Florida, United States

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Aventura, Florida, United States

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Bay Pines, Florida, United States

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Boynton Beach, Florida, United States

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Crystal River, Florida, United States

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Daytona Beach, Florida, United States

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Doral, Florida, United States

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Gainesville, Florida, United States

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Hialeah, Florida, United States

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Hialeah, Florida, United States

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Inverness, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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Naples, Florida, United States

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Ocala, Florida, United States

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Palm Harbor, Florida, United States

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Pembroke Pines, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Zephyrhills, Florida, United States

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Athens, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Columbus, Georgia, United States

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Smyrna, Georgia, United States

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Woodstock, Georgia, United States

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Honolulu, Hawaii, United States

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‘Aiea, Hawaii, United States

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Arlington Heights, Illinois, United States

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Champaign, Illinois, United States

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Chicago, Illinois, United States

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Fairview Heights, Illinois, United States

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Hazel Crest, Illinois, United States

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Maywood, Illinois, United States

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Oak Lawn, Illinois, United States

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Peoria, Illinois, United States

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Indianapolis, Indiana, United States

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Merrillville, Indiana, United States

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Muncie, Indiana, United States

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Munster, Indiana, United States

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Richmond, Indiana, United States

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Valparaiso, Indiana, United States

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Des Moines, Iowa, United States

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Iowa City, Iowa, United States

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Kansas City, Kansas, United States

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Overland Park, Kansas, United States

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Wichita, Kansas, United States

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Wichita, Kansas, United States

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Crestview Hills, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Alexandria, Louisiana, United States

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Lake Charles, Louisiana, United States

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Monroe, Louisiana, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Shreveport, Louisiana, United States

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West Monroe, Louisiana, United States

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Bangor, Maine, United States

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Biddeford, Maine, United States

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Portland, Maine, United States

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Scarborough, Maine, United States

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Baltimore, Maryland, United States

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Columbia, Maryland, United States

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Hagerstown, Maryland, United States

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Prince Frederick, Maryland, United States

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Salisbury, Maryland, United States

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Boston, Massachusetts, United States

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Haverhill, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Grand Blanc, Michigan, United States

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Kalamazoo, Michigan, United States

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Midland, Michigan, United States

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Royal Oak, Michigan, United States

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Saginaw, Michigan, United States

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Minneapolis, Minnesota, United States

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Port Gibson, Mississippi, United States

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Tupelo, Mississippi, United States

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Columbia, Missouri, United States

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Columbia, Missouri, United States

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Jefferson City, Missouri, United States

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Kansas City, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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North Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Lebanon, New Hampshire, United States

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Eatontown, New Jersey, United States

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Moorestown, New Jersey, United States

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Morristown, New Jersey, United States

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Newark, New Jersey, United States

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Ridgewood, New Jersey, United States

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Somerset, New Jersey, United States

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Voorhees Township, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Brooklyn, New York, United States

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Buffalo, New York, United States

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Cortlandt Manor, New York, United States

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Johnson City, New York, United States

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Kingston, New York, United States

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Laurelton, New York, United States

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Mineola, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Roslyn, New York, United States

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Saratoga Springs, New York, United States

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Stony Brook, New York, United States

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The Bronx, New York, United States

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Valhalla, New York, United States

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Asheville, North Carolina, United States

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Cary, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Greensboro, North Carolina, United States

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Hickory, North Carolina, United States

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Lenoir, North Carolina, United States

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Lumberton, North Carolina, United States

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Mooresville, North Carolina, United States

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Pinehurst, North Carolina, United States

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Tabor City, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Dayton, Ohio, United States

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Kettering, Ohio, United States

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Marion, Ohio, United States

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Sandusky, Ohio, United States

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Wiloughby, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Abington, Pennsylvania, United States

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Altoona, Pennsylvania, United States

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Butler, Pennsylvania, United States

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Camp Hill, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Jersey Shore, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Sayre, Pennsylvania, United States

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Yardley, Pennsylvania, United States

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York, Pennsylvania, United States

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Pawtucket, Rhode Island, United States

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Providence, Rhode Island, United States

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Providence, Rhode Island, United States

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Warwick, Rhode Island, United States

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Charleston, South Carolina, United States

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Charleston, South Carolina, United States

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Charleston, South Carolina, United States

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Fort Mill, South Carolina, United States

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Greenville, South Carolina, United States

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Rock Hill, South Carolina, United States

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Rapid City, South Dakota, United States

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Germantown, Tennessee, United States

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Jackson, Tennessee, United States

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Jackson, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Carrollton, Texas, United States

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Carrollton, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Denison, Texas, United States

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El Paso, Texas, United States

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Fort Sam Houston, Texas, United States

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Fort Worth, Texas, United States

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Galveston, Texas, United States

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Gonzales, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Huntsville, Texas, United States

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Lubbock, Texas, United States

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McKinney, Texas, United States

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Odessa, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Tomball, Texas, United States

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Wichita Falls, Texas, United States

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Farmington, Utah, United States

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Murray, Utah, United States

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Salt Lake City, Utah, United States

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Burlington, Vermont, United States

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White River Junction, Vermont, United States

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Charlottesville, Virginia, United States

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Leesburg, Virginia, United States

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Lynchburg, Virginia, United States

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Manassas, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Puyallup, Washington, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Huntington, West Virginia, United States

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Morgantown, West Virginia, United States

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Green Bay, Wisconsin, United States

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Madison, Wisconsin, United States

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Madison, Wisconsin, United States

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Madison, Wisconsin, United States

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Manitowoc, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Waukesha, Wisconsin, United States

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Bahía Blanca, Buenos Aires, Argentina

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CABA, Buenos Aires, Argentina

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CABA, Buenos Aires, Argentina

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CABA, Buenos Aires, Argentina

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CABA, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Coronel Suárez, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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Merlo, Buenos Aires, Argentina

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Quilmes, Buenos Aires, Argentina

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Quilmes, Buenos Aires, Argentina

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Ramos Meija, Buenos Aires, Argentina

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San Fernando, Buenos Aires, Argentina

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San Isidro, Buenos Aires, Argentina

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San Martín, Buenos Aires, Argentina

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San Nicolás de los Arroyos, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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Córdoba, Córdoba Province, Argentina

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Córdoba, Córdoba Province, Argentina

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Córdoba, Córdoba Province, Argentina

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Villa María, Córdoba Province, Argentina

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Santa Rosa, La Pampa Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Venado Tuerto, Santa Fe Province, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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Buenos Aires, , Argentina

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Corrientes, , Argentina

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Corrientes, , Argentina

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Córdoba, , Argentina

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Córdoba, , Argentina

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Córdoba, , Argentina

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Salta, , Argentina

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Santa Fe, , Argentina

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Garran, Australian Capital Territory, Australia

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Concord, New South Wales, Australia

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Darlinghurst, New South Wales, Australia

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Liverpool, New South Wales, Australia

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New Lambton Heights, New South Wales, Australia

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Chermside, Queensland, Australia

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Herston, Queensland, Australia

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Woolloongabba, Queensland, Australia

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Ashford, South Australia, Australia

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Bedford Park, South Australia, Australia

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Fullarton, South Australia, Australia

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Woodville South, South Australia, Australia

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Bundoora, Victoria, Australia

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Frankston, Victoria, Australia

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Geelong, Victoria, Australia

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Richmond, Victoria, Australia

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Murdoch, Western Australia, Australia

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Feldkirch, , Austria

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Graz, , Austria

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Innsbruck, , Austria

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Linz, , Austria

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Linz, , Austria

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Sankt Pölten, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Haskovo, , Bulgaria

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Edmonton, Alberta, Canada

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Bogota D.C., , Colombia

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Beroun, , Czechia

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Aalborg, , Denmark

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Béziers, , France

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Bad Neuheim, , Germany

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Ariccia, , Italy

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Ichinomiya-shi, Aichi-ken, Japan

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Fukushima, Fukushima, Japan

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Kaunas, , Lithuania

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Torreón, Coahuila, Mexico

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's-Hertogenbosch, , Netherlands

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Nijmegen, , Netherlands

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Christchurch, , New Zealand

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Bialystok, , Poland

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Poznan, , Poland

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Ruda Śląska, , Poland

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Snina, , Slovakia

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Bloemfontein, Free State, South Africa

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Falun, , Sweden

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Van, , Turkey (Türkiye)

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Dnipropetrovsk, , Ukraine

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Zaporizhzhia, , Ukraine

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Ayr, , United Kingdom

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Basingstoke, , United Kingdom

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Blackpool, , United Kingdom

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Cottingham, , United Kingdom

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Dudley, , United Kingdom

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Exeter, , United Kingdom

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Gillingham, , United Kingdom

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Northwood, , United Kingdom

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Portsmouth, , United Kingdom

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Romford, , United Kingdom

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Sheffield, , United Kingdom

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Solihull, , United Kingdom

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Stevenage, , United Kingdom

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Sunderland, , United Kingdom

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Swindon, , United Kingdom

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Taunton, , United Kingdom

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United States Argentina Australia Austria Belgium Brazil Bulgaria Canada Chile China Colombia Czechia Denmark France Germany Greece Hungary Italy Japan Lithuania Mexico Netherlands New Zealand Poland Portugal Puerto Rico Romania Russia Slovakia South Africa Spain Sweden Switzerland Turkey (Türkiye) Ukraine United Kingdom

References

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Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Biering-Sorensen T, Bohm M, Bonderman D, Fang JC, Lanfear DE, Lund M, Momomura SI, O'Meara E, Ponikowski P, Spinar J, Flores-Arredondo JH, Claggett BL, Heitner SB, Kupfer S, Abbasi SA, Malik FI; GALACTIC-HF Investigators. Effect of Ejection Fraction on Clinical Outcomes in Patients Treated With Omecamtiv Mecarbil in GALACTIC-HF. J Am Coll Cardiol. 2021 Jul 13;78(2):97-108. doi: 10.1016/j.jacc.2021.04.065. Epub 2021 May 17.

Reference Type BACKGROUND
PMID: 34015475 (View on PubMed)

Lu H, Claggett BL, Felker GM, McMurray JJV, Teerlink JR, Inciardi RM, Metra M, Heitner SB, Diaz R, Malik F, Vaduganathan M, Solomon SD. Efficacy and Safety of Omecamtiv Mecarbil in Heart Failure With Reduced Ejection Fraction According to Age: The GALACTIC-HF Trial. JACC Heart Fail. 2025 Oct 22:102703. doi: 10.1016/j.jchf.2025.102703. Online ahead of print.

Reference Type DERIVED
PMID: 41123512 (View on PubMed)

Felker GM, Solomon SD, Metra M, Mcmurray JJV, Diaz R, Claggett B, Lanfear DE, Vandekerckhove H, Biering-Sorensen T, Lopes RD, Arias-Mendoza A, Momomura SI, Corbalan R, Ramires FJA, Zannad F, Heitner SB, Divanji PH, Kupfer S, Malik FI, Teerlink JR. Cardiac Troponin and Treatment Effects of Omecamtiv Mecarbil: Results From the GALACTIC-HF Study. J Card Fail. 2024 Jun;30(6):755-763. doi: 10.1016/j.cardfail.2023.11.021. Epub 2024 Jan 11.

Reference Type DERIVED
PMID: 38215932 (View on PubMed)

Pabon M, Cunningham J, Claggett B, Felker GM, McMurray JJV, Metra M, Diaz R, Wang X, Arias-Mendoza A, Bonderman D, Crespo-Leiro M, Fonseca C, Goncalvesova E, Lund M, O'Meara E, Sliwa-Hahnle K, Malik FI, Solomon SD, Teerlink JR; GALACTIC-HF Investigators. Sex Differences in Heart Failure With Reduced Ejection Fraction in the GALACTIC-HF Trial. JACC Heart Fail. 2023 Dec;11(12):1729-1738. doi: 10.1016/j.jchf.2023.07.029. Epub 2023 Oct 11.

Reference Type DERIVED
PMID: 37831045 (View on PubMed)

Docherty KF, McMurray JJV, Claggett BL, Miao ZM, Adams KF, Arias-Mendoza A, Cleland JGF, Diaz R, Echeverria Correa LE, Felker GM, Fonseca C, Li J, Metra M, Sliwa-Hahnle K, Solomon SD, Vandekerckhove HJ, Vinereanu D, Voors AA, Heitner SB, Kupfer S, Malik FI, Meng L, Teerlink JR. Efficacy of omecamtiv mecarbil in heart failure with reduced ejection fraction according to N-terminal pro-B-type natriuretic peptide level: insights from the GALACTIC-HF trial. Eur J Heart Fail. 2023 Feb;25(2):248-259. doi: 10.1002/ejhf.2763. Epub 2023 Jan 16.

Reference Type DERIVED
PMID: 36597719 (View on PubMed)

Solomon SD, Claggett BL, Miao ZM, Diaz R, Felker GM, McMurray JJV, Metra M, Corbalan R, Filippatos G, Goudev AR, Mareev V, Serpytis P, Suter T, Yilmaz MB, Zannad F, Kupfer S, Heitner SB, Malik FI, Teerlink JR. Influence of atrial fibrillation on efficacy and safety of omecamtiv mecarbil in heart failure: the GALACTIC-HF trial. Eur Heart J. 2022 Jun 14;43(23):2212-2220. doi: 10.1093/eurheartj/ehac144.

Reference Type DERIVED
PMID: 35325102 (View on PubMed)

Felker GM, Solomon SD, Claggett B, Diaz R, McMurray JJV, Metra M, Anand I, Crespo-Leiro MG, Dahlstrom U, Goncalvesova E, Howlett JG, MacDonald P, Parkhomenko A, Tomcsanyi J, Abbasi SA, Heitner SB, Hucko T, Kupfer S, Malik FI, Teerlink JR. Assessment of Omecamtiv Mecarbil for the Treatment of Patients With Severe Heart Failure: A Post Hoc Analysis of Data From the GALACTIC-HF Randomized Clinical Trial. JAMA Cardiol. 2022 Jan 1;7(1):26-34. doi: 10.1001/jamacardio.2021.4027.

Reference Type DERIVED
PMID: 34643642 (View on PubMed)

Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Adams KF, Anand I, Arias-Mendoza A, Biering-Sorensen T, Bohm M, Bonderman D, Cleland JGF, Corbalan R, Crespo-Leiro MG, Dahlstrom U, Echeverria LE, Fang JC, Filippatos G, Fonseca C, Goncalvesova E, Goudev AR, Howlett JG, Lanfear DE, Li J, Lund M, Macdonald P, Mareev V, Momomura SI, O'Meara E, Parkhomenko A, Ponikowski P, Ramires FJA, Serpytis P, Sliwa K, Spinar J, Suter TM, Tomcsanyi J, Vandekerckhove H, Vinereanu D, Voors AA, Yilmaz MB, Zannad F, Sharpsten L, Legg JC, Varin C, Honarpour N, Abbasi SA, Malik FI, Kurtz CE; GALACTIC-HF Investigators. Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure. N Engl J Med. 2021 Jan 14;384(2):105-116. doi: 10.1056/NEJMoa2025797. Epub 2020 Nov 13.

Reference Type DERIVED
PMID: 33185990 (View on PubMed)

Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Legg JC, Buchele G, Varin C, Kurtz CE, Malik FI, Honarpour N. Omecamtiv Mecarbil in Chronic Heart Failure With Reduced Ejection Fraction: Rationale and Design of GALACTIC-HF. JACC Heart Fail. 2020 Apr;8(4):329-340. doi: 10.1016/j.jchf.2019.12.001. Epub 2020 Feb 6.

Reference Type DERIVED
PMID: 32035892 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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2016-002299-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

20110203

Identifier Type: -

Identifier Source: org_study_id