Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment

Last updated: September 30, 2022
Sponsor: Kowa Research Institute, Inc.
Overall Status: Completed

Phase

3

Condition

Hypertriglyceridemia

Treatment

N/A

Clinical Study ID

NCT03011450
K-877-303
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients With Fasting High Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Mild or Moderate Renal Impairment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Able to understand and willing to comply with all study requirements and proceduresthroughout the duration of the study and give written informed consent;
  2. Aged ≥18 years;
  3. Patients receiving moderate- or high-intensity statin therapy must meet one of thefollowing criteria¹ unless they have any exceptional conditions (see inclusioncriterion 4):
  4. Aged ≥21 years with clinical atherosclerotic cardiovascular disease (ASCVD) (history of acute coronary syndrome or myocardial infarction, stable or unstableangina, coronary or other arterial revascularization, stroke, transient ischemicattack [TIA] presumed to be of atherosclerotic origin, or peripheral arterialdisease or revascularization), on a high-intensity statin (or moderate-intensitystatin if not a candidate for high-intensity statin due to safety concerns);
  5. Aged ≥21 years with a history of LDL-C ≥190 mg/dL, which is not due to secondarymodifiable causes, on a high-intensity statin (or moderate-intensity statin ifnot a candidate for high-intensity statin due to safety concerns);
  6. Aged 40 to 75 years, inclusive, without clinical ASCVD but with diabetes and ahistory of LDL-C of 70 to 189 mg/dL, inclusive, on a moderate- or high-intensitystatin; or
  7. Aged 40 to 75 years, inclusive, without clinical ASCVD or diabetes, with ahistory of LDL-C of 70 to 189 mg/dL, inclusive, with estimated 10-year risk forASCVD of ≥7.5% by the Pooled Cohort Equation on a moderate- or high-intensitystatin;
  8. Patients currently on a low-intensity statin or not on a statin, must meet one of thefollowing criteria;
  9. Patient does not meet any criteria for moderate- or high-intensity statin therapylisted above (see inclusion criteria, 3.a. through 3.d.);
  10. Patient does meet one or more criteria for moderate- or high-intensity statintherapy listed above (see inclusion criteria 3.a. through 3.d.); but the patientis not a candidate for moderate or high-intensity statin due to safety concerns,or due to partial or complete statin intolerance; or
  11. Patient does meet one or more criteria for moderate- or high intensity statintherapy listed above (see inclusion criteria 3.b. through 3.d., except for 3.a.);but the patient is not a candidate for moderate or high intensity statin forprimary prevention after considering individual risk evaluation (e.g. current LDLC ≤70mg/dL) and patient preference;
  12. Fasting TG levels ≥500 mg/dL (5.65 mmol/L) and <2000 mg/dL (22.60 mmol/L) based on themean of Visit 2 (Week -2) and Visit 3 (Week -1).
  • Mild to moderate renal impairment eGFR >= 30mL/min/1.73 and < 90 mL/min/1.73 atVisit 1

Exclusion

Exclusion Criteria:

  1. Patients who will require lipid-altering treatments other than study drugs (K-877 orfenofibrate), statins, ezetimibe, or PCSK9 inhibitors during the course of the study.These include bile acid sequestrants, non-study fibrates, niacin (>100 mg/day),omega-3 fatty acids (>1000 mg/day), or any supplements used to alter lipid metabolismincluding, but not limited to, red rice yeast supplements, garlic supplements, soyisoflavone supplements, sterol/stanol products, or policosanols;
  2. Body mass index (BMI) >45 kg/m2 at Visit 1 (Week -8 or Week -6);
  3. Patients with type 1 diabetes mellitus;
  4. Patients with newly diagnosed (within 3 months prior to Visit 2 [Week -2]) or poorlycontrolled type 2 diabetes mellitus (T2DM), defined as hemoglobin A1c >9.5% at Visit 1 (Week -8 or Week -6);

Study Design

Total Participants: 471
Study Start date:
November 26, 2016
Estimated Completion Date:
July 05, 2019

Connect with a study center

  • Brest Regional Hospital

    Brest, 224027
    Belarus

    Site Not Available

  • Gomel Regional Clinical Center of Cardiology

    Gomel, 246046
    Belarus

    Site Not Available

  • Gomel Regional Clinical Hospital

    Gomel, 246029
    Belarus

    Site Not Available

  • Grodno University Hospital

    Grodno, 230030
    Belarus

    Site Not Available

  • City Clinical Hospital #1

    Minsk, 220013
    Belarus

    Site Not Available

  • City Clinical Hospital #10

    Minsk, 220096
    Belarus

    Site Not Available

  • City Clinical Hospital #9

    Minsk, 220045
    Belarus

    Site Not Available

  • Minsk Regional Clinical Hospital

    Minsk, 223041
    Belarus

    Site Not Available

  • Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology

    Minsk, 220045
    Belarus

    Site Not Available

  • Mogilev Regional Medical and Diagnostic Center

    Mogilev, 212030
    Belarus

    Site Not Available

  • Vitebsk Regional Clinical Hospital

    Vitebsk, 210037
    Belarus

    Site Not Available

  • Medical Center Diamedical 2013 OOD

    Dimitrovgrad, 6400
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- First Cardiology Clinic

    Pleven, 5800
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- Second Cardiology Clinic

    Pleven, 5800
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment (UMHAT) Sveti Georgi, EAD - Clinic of Cardiology

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • MHAT Dr. Bratan Shukjerov

    Smolyan, 4700
    Bulgaria

    Site Not Available

  • Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD

    Smolyan, 4700
    Bulgaria

    Site Not Available

  • Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Cardiology

    Sofia, 1233
    Bulgaria

    Site Not Available

  • Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Endocrinology and Meteorism Diseases

    Sofia, 1233
    Bulgaria

    Site Not Available

  • Medical Center Orfey OOD

    Stara Zagora, 6000
    Bulgaria

    Site Not Available

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    Brandýs nad Labem, 250 01
    Czechia

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    Bílina, 41801
    Czechia

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    Hradec Králové, 500 05
    Czechia

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  • Ordinace pro choroby srdce a cev

    Praha 10, 101 00
    Czechia

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    Praha 2, 128 08
    Czechia

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    Praha 5, 15006
    Czechia

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    Trutnov, 541 21
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    Uherské Hradište, 68601
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    Batumi, 6010
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    Kutaisi, 4600
    Georgia

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    Tbilisi, 102
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    Tbilisi, 159
    Georgia

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    Tbilisi, 159
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  • Institute of Clinical Cardiology Ltd

    Tbilisi, 159
    Georgia

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    Tbilisi, 159
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    Telavi, 2200
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    Balatonfüred, H-8230
    Hungary

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  • DRC Balatongyorok

    Balatongyörök, H-8313
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  • Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly

    Budapest, 1062
    Hungary

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  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1134
    Hungary

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  • Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo

    Békéscsaba, 5600
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  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, H-4032
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  • BKS Research Kft.

    Hatvan, 3000
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  • Pecsi Tudomanyegyetem Klinikai Kozpont I.sz. Belgyogyaszati Klinika

    Pécs, 7624
    Hungary

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  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000
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    Gdynia, 81-157
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    Katowice, 40-772
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    Krakow, 31-534
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    Poznań, 60-589
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    Poznań, 61-655
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    Płock, 09-400
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    Skierniewice, 96-100
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    Wrocław, 50-315
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    Łódź, 94-048
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    Kazan, 420101
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    Kazan, 420103
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    Kazan', 42012
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    Kemerovo, 650002
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    Kirovsk, 187342
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    Krasnoyarsk, 660062
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    Site Not Available

  • Central Clinical Hospital of Russian Academy of Sciences

    Moscow, 117593
    Russian Federation

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  • City Clinical Hospital #15 n.a. O.M. Filatov

    Moscow, 111539
    Russian Federation

    Site Not Available

  • City Clinical Hospital n.a. M.E. Zhadkevich of Moscow Healthcare Department

    Moscow, 121374
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    Site Not Available

  • City Clinical Hospital n.a. M.P. Konchalovskiy

    Moscow, 124489
    Russian Federation

    Site Not Available

  • Federal State Budget Institution "Outpatient Clinic #3" of Russian Federation President's Management Department

    Moscow, 129090
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    Site Not Available

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    Moscow, 121552
    Russian Federation

    Site Not Available

  • National Medical Research Center of Cardiology - Department of Atherosclerosis

    Moscow, 121552
    Russian Federation

    Site Not Available

  • National Medical Research Center of Preventive Medicine

    Moscow, 101990
    Russian Federation

    Site Not Available

  • Non-governmental Private Healthcare Institution "Scientific Clinical Centre of Open Joint-Stock Company Russian Railways" (JSC "RZD")

    Moscow, 125315
    Russian Federation

    Site Not Available

  • City Clinical Hospital No.2

    Novosibirsk, 630051
    Russian Federation

    Site Not Available

  • RC Medical LLC

    Novosibirsk, 630091
    Russian Federation

    Site Not Available

  • Research Institute of Physiology and Fundamental Medicine

    Novosibirsk, 630117
    Russian Federation

    Site Not Available

  • Orenburg State Medical University based at City Clinical Hospital #1

    Orenburg, 460000
    Russian Federation

    Site Not Available

  • Clinical-diagnostic center Zdorovye

    Rostov-on-Don, 344011
    Russian Federation

    Site Not Available

  • Rostov-on-Don City Hospital of Emergency Care

    Rostov-on-Don, 344068
    Russian Federation

    Site Not Available

  • Almazov National Medical Research Centre, Scientific Laboratory of Electrocardiology

    Saint Petersburg, 197341
    Russian Federation

    Site Not Available

  • BioTechService LLC

    Saint Petersburg, 197022
    Russian Federation

    Site Not Available

  • City hospital #38 n.a. N.A. Semashko

    Saint Petersburg, 196601
    Russian Federation

    Site Not Available

  • Clinic Complex JSC

    Saint Petersburg, 190013
    Russian Federation

    Site Not Available

  • Consultative Diagnostic Center with Out-patient Clinic

    Saint Petersburg, 197110
    Russian Federation

    Site Not Available

  • Limited Liability Company MedPomosch

    Saint Petersburg, 194356
    Russian Federation

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  • Medical Technologies LLC

    Saint Petersburg, 191025
    Russian Federation

    Site Not Available

  • North-Western State Medical University named after I.I. Mechnikov

    Saint Petersburg, 191015
    Russian Federation

    Site Not Available

  • Saint-Petersburg State Budget Healthcare Institution "City Pokrovskaya Hospital", Department of Cardiology N.3

    Saint Petersburg, 199106
    Russian Federation

    Site Not Available

  • Regional Clinical Cardiology Dispensary

    Saratov, 410028
    Russian Federation

    Site Not Available

  • Saratov State Medical University n. a. V.I. Razumovsky

    Saratov, 410054
    Russian Federation

    Site Not Available

  • Almazov National Medical Research Centre

    St. Petersburg, 194156
    Russian Federation

    Site Not Available

  • Clinical Hospital #122 n. a. L.G. Sokolov of the Federal Medical Biological Agency

    St. Petersburg, 194291
    Russian Federation

    Site Not Available

  • Tomsk National Research Medical Center of Russian Academy of Sciences

    Tomsk, 634012
    Russian Federation

    Site Not Available

  • Autonomous Institution of healthcare of the Voronezh region "Voronezh regional clinical consultative and diagnostic centre

    Voronezh, 394018
    Russian Federation

    Site Not Available

  • Yaroslavl Regional Clinical Hospital for War Veterans - International Center on the Problems of the Elderly "Zdorovoe Dolgoletie"

    Yaroslavl, 150047
    Russian Federation

    Site Not Available

  • Ivano-Frankivsk Regional Clinical Cardiological Dispensary, Chronic Ischaemic Heart Disease Department

    Ivano-Frankivs'k, 76018
    Ukraine

    Site Not Available

  • Kharkiv Medical Academy of Postgraduate Education

    Kharkiv, 61103
    Ukraine

    Site Not Available

  • Kharkiv Railway Clinic. Hosp.#1, Branch Office of "Healthcare Center" of PJSC "Ukr. Railways", Cardiology Depart #2

    Kharkiv, 61103
    Ukraine

    Site Not Available

  • Kharkiv Railway Clinic. Hosp.#1, Branch Office of Healthcare Center of PJSC Ukr. Railways, Cardiology Depart #1

    Kharkiv, 61103
    Ukraine

    Site Not Available

  • Municipal Healthcare Institution Kharkiv City Clinical Hospital #27, Intensive Therapy Department

    Kharkiv, 61002
    Ukraine

    Site Not Available

  • Municipal Healthcare Institution Kharkiv City Outpatient Clinic #9, General Practice and Family Medicine Department #1

    Kharkiv, 61172
    Ukraine

    Site Not Available

  • Municipal Non-Commercial Enterprise "City Clinical Emergency Hospital n.a. prof. O.I. Meshchaninov of Kharkiv City Council

    Kharkiv, 61103
    Ukraine

    Site Not Available

  • Kyiv City Clinical Hospital #1, Urgent Cardiology Department

    Kyiv, 2091
    Ukraine

    Site Not Available

  • Limited Liability Company Treatment and Diagnostic Center Adonis Plus, Outpatient Department

    Kyiv, 2002
    Ukraine

    Site Not Available

  • SI Institute of Gerontology n.a. D.F.Chebotarev NAMS of Ukraine, Cardiol. Un. of Clin. Physiology and Int. Organs Path. Dep-t

    Kyiv, 4114
    Ukraine

    Site Not Available

  • SI Institute of Gerontology n.a. D.F.Chebotarev NAMS of Ukraine, Cardiol. Un. of Clin. Physiology and Int. Organs Path. Dep-t., Gen. Ther.Unit

    Kyiv, 4114
    Ukraine

    Site Not Available

  • Municipal Institution City Clinical Hospital #3 n.a. prof. L.J. Aleinikova, Cardiology Intensive Therapy Department

    Odesa, 65014
    Ukraine

    Site Not Available

  • Small Private Enterprise, Medical Centre Puls

    Vinnytsya, 21001
    Ukraine

    Site Not Available

  • Municipal Institution City Clinical Hospital #6, Therapeutic Department

    Zaporizhzhia, 69035
    Ukraine

    Site Not Available

  • Cahaba Research, Inc.

    Birmingham, Alabama 35242
    United States

    Site Not Available

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    Birmingham, Alabama 35209
    United States

    Site Not Available

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    Birmingham, Alabama 35205
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    Site Not Available

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    Hamilton, Alabama 35570
    United States

    Site Not Available

  • Longwood Research - Saadat Ansari, MD, LLC

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Terence T. Hart, MD

    Tuscumbia, Alabama 35674
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    Glendale, Arizona 85306
    United States

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  • Phoenix Medical Research Institute, LLC

    Peoria, Arizona 85381
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    Site Not Available

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    Phoenix, Arizona 85018
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    Surprise, Arizona 85374
    United States

    Site Not Available

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    Little Rock, Arkansas 72205
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    Little Rock, Arkansas 72205
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    Anaheim, California 92805
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    Lomita, California 90717
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    Los Angeles, California 90017
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    Montclair, California 91763
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    Norwalk, California 90650
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    San Diego, California 92117
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    San Francisco, California 94102
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    Atlantis, Florida 33462
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    Boynton Beach, Florida 33472
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    Cooper City, Florida 33024
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    Las Vegas, Nevada 89148
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    Site Not Available

  • Diabetes and Endocrinology Consultants, P.C.

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Lillestol Research, LLC

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Sterling Research Group, Ltd. - Auburn

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Aventiv Research, Inc.

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Alpha Research Associates, LLC

    Dayton, Ohio 45417
    United States

    Site Not Available

  • Prestige Clinical Research

    Franklin, Ohio 45005
    United States

    Site Not Available

  • Ohio Clinical Research - Lyndhurst

    Lyndhurst, Ohio 44124
    United States

    Site Not Available

  • RAS Health Ltd

    Marion, Ohio 43302
    United States

    Site Not Available

  • Rama Research LLC

    Marion, Ohio 43302
    United States

    Site Not Available

  • Summit Research Group, LLC

    Munroe Falls, Ohio 44626
    United States

    Site Not Available

  • Ohio Clinical Research, LLC - Willoughby Hills

    Willoughby Hills, Ohio 44094
    United States

    Site Not Available

  • COR Clinical Research, LLC.

    Oklahoma City, Oklahoma 73107
    United States

    Site Not Available

  • South Oklahoma Heart Research

    Oklahoma City, Oklahoma 73135
    United States

    Site Not Available

  • Clinical Research Associates of Central PA, LLC

    Altoona, Pennsylvania 16602
    United States

    Site Not Available

  • Harleysville Medical Associates

    Harleysville, Pennsylvania 19438
    United States

    Site Not Available

  • Richard M.Kastelic MD and Associates

    Johnstown, Pennsylvania 15905
    United States

    Site Not Available

  • Green and Seidner Family Practice Associates

    Lansdale, Pennsylvania 19446
    United States

    Site Not Available

  • Center for Medical Research, LLC

    Providence, Rhode Island 2908
    United States

    Site Not Available

  • MD First Research

    Anderson, South Carolina 29625
    United States

    Site Not Available

  • MDFirst Research - Anderson

    Anderson, South Carolina 29625
    United States

    Site Not Available

  • DeGarmo Institute Of Medical Research

    Greer, South Carolina 29650
    United States

    Site Not Available

  • MD First Research

    Lancaster, South Carolina 29720
    United States

    Site Not Available

  • Family Medicine of SayeBrook

    Myrtle Beach, South Carolina 29588
    United States

    Site Not Available

  • Health Concepts

    Rapid City, South Dakota 57702
    United States

    Site Not Available

  • PMG Research of Bristol, LLC - State

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • Chattanooga Research & Medicine, PLLC

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Holston Medical Group

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • New Phase Research & Development

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Clinical Research Solutions - Smyrna, TN

    Smyrna, Tennessee 37167
    United States

    Site Not Available

  • Health Innovation Research Group

    Arlington, Texas 76014
    United States

    Site Not Available

  • DCT-AACT, LLC, dba Discovery Clinical Trials

    Austin, Texas 78758
    United States

    Site Not Available

  • Inquest Clinical Research

    Baytown, Texas 77521
    United States

    Site Not Available

  • Padre Coast Clinical Research

    Corpus Christi, Texas 78404
    United States

    Site Not Available

  • Protenium Clinical Research, LLC - Dallas

    Dallas, Texas 75208
    United States

    Site Not Available

  • VA North Texas Health Care System - Dallas VA Medical Center (DVAMC)

    Dallas, Texas 75216
    United States

    Site Not Available

  • Academy of Diabetes, Thyroid and Endocrine, P.A.

    El Paso, Texas 79935
    United States

    Site Not Available

  • Centex Studies, Inc.

    Houston, Texas 77058
    United States

    Site Not Available

  • Juno Research, LLC

    Houston, Texas 77074
    United States

    Site Not Available

  • Pioneer Research Solutions Inc.

    Houston, Texas 77099
    United States

    Site Not Available

  • Grace Research, LLC

    Huntsville, Texas 77340
    United States

    Site Not Available

  • Protenium Clinical Research, LLC

    Hurst, Texas 76054
    United States

    Site Not Available

  • Juno Research, LLC

    Katy, Texas 77450
    United States

    Site Not Available

  • FMC Science

    Lampasas, Texas 76550
    United States

    Site Not Available

  • Pinnacle Clinical Research

    Live Oak, Texas 78233
    United States

    Site Not Available

  • DCT - McAllen Primary Care, LLC

    McAllen, Texas 78503
    United States

    Site Not Available

  • empty

    Palestine, Texas 75801
    United States

    Site Not Available

  • Bandera Family HealthCare Research, LLC (BFHC)

    San Antonio, Texas 78249
    United States

    Site Not Available

  • Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute

    San Antonio, Texas 78228
    United States

    Site Not Available

  • San Antonio Premier Internal Medicine

    San Antonio, Texas 78220
    United States

    Site Not Available

  • empty

    Orem, Utah 84058
    United States

    Site Not Available

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Site Not Available

  • York Clinical Research LLC

    Norfolk, Virginia 23501
    United States

    Site Not Available

  • Cardiovascular Associates, Ltd

    Virginia Beach, Virginia 23454
    United States

    Site Not Available

  • Exemplar Research Inc. - Fairmont, WV

    Morgantown, West Virginia 26505
    United States

    Site Not Available

  • Allegiance Research Specialists, LLC

    Wauwatosa, Wisconsin 53226
    United States

    Site Not Available

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