Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function
Sponsor
Kowa Research Institute, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03001817
Collaborator
(none)
551
220
2
30.8
2.5
0.1
Study Details
Study Description
Brief 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 normal renal function.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
551 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double-Blind, 12-Week Study With a 40-Week Open-Label Extension to Evaluate the Efficacy and Safety of K-877 0.2 mg Twice Daily in Patients With Fasting Triglyceride Levels ≥500 mg/dL and <2000 mg/dL
Actual Study Start Date
:
Nov 28, 2016
Actual Primary Completion Date
:
Jun 24, 2019
Actual Study Completion Date
:
Jun 24, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: 12 Week Efficacy K-877 or placebo comparator twice daily for 12 weeks |
Drug: K-877
Drug: Placebo (for K-877)
|
| Active Comparator: 40 Week Extension K-877 with placebo matching fenofibrate or fenofibrate with placebo matching K-877 for 40 weeks |
Drug: K-877
Drug: Fenofibrate
Drug: Placebo (for K-877)
Drug: Placebo (for Fenofibrate)
|
Outcome Measures
Primary Outcome Measures
- Percent change of Fasting Triglyceride(TG) Levels [12 Weeks]
Percent change in fasting Triglyceride(TG) levels from baseline to Week 12
Secondary Outcome Measures
- Percent change of Fasting TG Levels [52 Weeks]
Percent change in fasting TG levels from baseline to Week 52
- Percent Change of Other Lipid Parameters [12 weeks, and 52 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Able to understand and willing to comply with all study requirements and procedures throughout the duration of the study and give written informed consent;
-
Aged ≥18 years;
-
Patients receiving moderate- or high-intensity statin therapy must meet one of the following criteria¹ unless they have any exceptional conditions (see inclusion criterion 4):
-
Aged ≥21 years with clinical atherosclerotic cardiovascular disease (ASCVD) (history of acute coronary syndrome or myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack [TIA] presumed to be of atherosclerotic origin, or peripheral arterial disease or revascularization), on a high-intensity statin (or moderate-intensity statin if not a candidate for high-intensity statin due to safety concerns);
-
Aged ≥21 years with a history of LDL-C ≥190 mg/dL, which is not due to secondary modifiable causes, on a high-intensity statin (or moderate-intensity statin if not a candidate for high-intensity statin due to safety concerns);
-
Aged 40 to 75 years, inclusive, without clinical ASCVD but with diabetes and a history of LDL-C of 70 to 189 mg/dL, inclusive, on a moderate- or high-intensity statin; or
-
Aged 40 to 75 years, inclusive, without clinical ASCVD or diabetes, with a history of LDL-C of 70 to 189 mg/dL, inclusive, with estimated 10-year risk for ASCVD of ≥7.5% by the Pooled Cohort Equation on a moderate- or high-intensity statin;
-
Patients currently on a low-intensity statin or not on a statin, must meet one of the following criteria:
-
Patient does not meet any criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria, criterion 3.a. through 3.d.);
-
Patient does meet one or more criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria 3.a. through 3.d.); but the patient is not a candidate for moderate or high-intensity statin due to safety concerns, or due to partial or complete statin intolerance; or
-
Patient does meet one or more criteria for moderate- or high intensity statin therapy 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 for primary prevention after considering individual risk evaluation (e.g. current LDL C ≤70mg/dL) and patient preference;
Exclusion Criteria:
-
Patients who will require lipid-altering treatments other than study drugs (K-877 or fenofibrate), 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 metabolism including, but not limited to, red rice yeast supplements, garlic supplements, soy isoflavone supplements, sterol/stanol products, or policosanols;
-
Body mass index (BMI) >45 kg/m2 at Visit 1 (Week -8 or Week -6);
-
Patients with type 1 diabetes mellitus;
-
Patients with newly diagnosed (within 3 months prior to Visit 2 [Week -2]) or poorly controlled type 2 diabetes mellitus (T2DM), defined as hemoglobin A1c >9.5% at Visit 1 (Week -8 or Week -6);
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Central Research Associates, Inc. | Birmingham | Alabama | United States | 35205 |
| 2 | Central Alabama Research | Birmingham | Alabama | United States | 35209 |
| 3 | Cahaba Research, Inc. | Birmingham | Alabama | United States | 35242 |
| 4 | Boyett Health Services Inc | Hamilton | Alabama | United States | 35570 |
| 5 | Longwood Research - Saadat Ansari, MD, LLC | Huntsville | Alabama | United States | 35801 |
| 6 | Terence T. Hart, MD | Tuscumbia | Alabama | United States | 35674 |
| 7 | Arrowhead Health Centers | Glendale | Arizona | United States | 85306 |
| 8 | Phoenix Medical Research Institute, LLC | Peoria | Arizona | United States | 85381 |
| 9 | Elite Clinical Studies | Phoenix | Arizona | United States | 85018 |
| 10 | Clinical Research Institute of Arizona, LLC | Surprise | Arizona | United States | 85374 |
| 11 | iResearch - Little Rock | Little Rock | Arkansas | United States | 72205 |
| 12 | Lynn Institute of the Ozarks | Little Rock | Arkansas | United States | 72205 |
| 13 | Advanced Research Center | Anaheim | California | United States | 92805 |
| 14 | Torrance Clinical Research Institute Inc. | Lomita | California | United States | 90717 |
| 15 | Downtown L.A. Research Center, Inc. | Los Angeles | California | United States | 90017 |
| 16 | Catalina Research Institute, LLC | Montclair | California | United States | 91763 |
| 17 | Lucita M. Cruz, MD., Inc. | Norwalk | California | United States | 90650 |
| 18 | Creekside Endocrine Associates, PC | Denver | Colorado | United States | 80246 |
| 19 | Atlantic Clinical Research Collaborative | Boynton Beach | Florida | United States | 33472 |
| 20 | ALL Medical Research, LLC | Cooper City | Florida | United States | 33024 |
| 21 | S & W Clinical Research | Fort Lauderdale | Florida | United States | 33306 |
| 22 | Indago Research and Health Center | Hialeah | Florida | United States | 33012 |
| 23 | Jacksonville Impotence Treatment Center | Jacksonville | Florida | United States | 32223 |
| 24 | AMPM Research Clinic | Miami Gardens | Florida | United States | 33169 |
| 25 | Advanced Research Institute Inc | New Port Richey | Florida | United States | 34653 |
| 26 | Ocala Cardiovascular Research | Ocala | Florida | United States | 34474 |
| 27 | South Florida Research Solutions LLC. - Pembroke Pines | Pembroke Pines | Florida | United States | 33029 |
| 28 | Progressive Medical Research | Port Orange | Florida | United States | 32127 |
| 29 | Cardiovascular Center of Sarasota | Sarasota | Florida | United States | 34239 |
| 30 | Meridien Research - Tampa | Tampa | Florida | United States | 33634 |
| 31 | Columbus Regional Health | Columbus | Georgia | United States | 31904 |
| 32 | Physicians Research Associates, Inc | Lawrenceville | Georgia | United States | 30046 |
| 33 | Georgia Institute for Clinical Research | Marietta | Georgia | United States | 30060 |
| 34 | Meridian Clinical Research - Savannah, GA | Savannah | Georgia | United States | 31406 |
| 35 | Solaris Clinical Research | Meridian | Idaho | United States | 83646 |
| 36 | Apex Medical Research - Illinois | Chicago | Illinois | United States | 60616 |
| 37 | Lemah Creek Clinical Research | Melrose Park | Illinois | United States | 60160 |
| 38 | Koch Family Medicine | Morton | Illinois | United States | 61550 |
| 39 | Community Hospital of Anderson and Madison County, Inc | Anderson | Indiana | United States | 46011 |
| 40 | American Health Network - Avon Clinical Research Department | Avon | Indiana | United States | 46103 |
| 41 | Medisphere Medical Research Center | Evansville | Indiana | United States | 47714 |
| 42 | Midwest Institute for Clinical Research | Indianapolis | Indiana | United States | 46260 |
| 43 | Buynak Clinical Research, P.C. | Valparaiso | Indiana | United States | 46383 |
| 44 | West Broadway Clinic | Council Bluffs | Iowa | United States | 51501 |
| 45 | The Iowa Clinic - Cardiovascular Services | West Des Moines | Iowa | United States | 50266 |
| 46 | Professional Research Network of Kansas, LLC | Wichita | Kansas | United States | 67205-1138 |
| 47 | The Research Group of Lexington, LLC | Lexington | Kentucky | United States | 40503 |
| 48 | Research Integrity LLC | Owensboro | Kentucky | United States | 42303 |
| 49 | Clinical Trials Management, LLC - Northshore | Covington | Louisiana | United States | 70443 |
| 50 | Clinical Trials Management LLC - Southshore | Metairie | Louisiana | United States | 70006 |
| 51 | Clinical Trials of America, LLC - West Monroe, LA | West Monroe | Louisiana | United States | 71291 |
| 52 | Maryland Cardiovascular Specialist | Baltimore | Maryland | United States | 21229 |
| 53 | Aa Mrc, Llc | Flint | Michigan | United States | 48504 |
| 54 | Oakland Medical Research Center | Troy | Michigan | United States | 48085 |
| 55 | David M. Headley, MD P.A. | Port Gibson | Mississippi | United States | 39150 |
| 56 | Consult and Research Associates | Saint Louis | Missouri | United States | 63122 |
| 57 | Advance Clinical Research, Inc | Saint Louis | Missouri | United States | 63128 |
| 58 | Glacier View Research Institute | Kalispell | Montana | United States | 59901 |
| 59 | Desert Endocrinology Clinical Research Center - Henderson | Henderson | Nevada | United States | 89052 |
| 60 | Palm Research Center, Inc. | Las Vegas | Nevada | United States | 89148 |
| 61 | Lovelace Scientific Resources | Albuquerque | New Mexico | United States | 87108 |
| 62 | Lakeshore Primary Care Associate | Hamburg | New York | United States | 14075 |
| 63 | Mid-Hudson Medical Research, PLLC - Hopewell Junction | New Windsor | New York | United States | 12553 |
| 64 | Mid-Hudson Medical Research, PLLC - New Windsor | New Windsor | New York | United States | 12553 |
| 65 | Orchard Park Family Practice | Orchard Park | New York | United States | 14127 |
| 66 | Diabetes and Endocrinology Consultants, P.C. | Morehead City | North Carolina | United States | 28557 |
| 67 | Lillestol Research, LLC | Fargo | North Dakota | United States | 58104 |
| 68 | Sterling Research Group, Ltd. - Auburn | Cincinnati | Ohio | United States | 45219 |
| 69 | Aventiv Research, Inc. | Columbus | Ohio | United States | 43213 |
| 70 | Alpha Research Associates, LLC | Dayton | Ohio | United States | 45417 |
| 71 | Prestige Clinical Research | Franklin | Ohio | United States | 45005 |
| 72 | Ohio Clinical Research - Lyndhurst | Lyndhurst | Ohio | United States | 44124 |
| 73 | Rama Research LLC | Marion | Ohio | United States | 43302 |
| 74 | RAS Health Ltd | Marion | Ohio | United States | 43302 |
| 75 | Summit Research Group, LLC | Munroe Falls | Ohio | United States | 44262 |
| 76 | Ohio Clinical Research, LLC - Willoughby Hills | Willoughby Hills | Ohio | United States | 44094 |
| 77 | South Oklahoma Heart Research | Oklahoma City | Oklahoma | United States | 73135 |
| 78 | Clinical Research Associates of Central PA, LLC | Altoona | Pennsylvania | United States | 16602 |
| 79 | Harleysville Medical Associates | Harleysville | Pennsylvania | United States | 19438 |
| 80 | Richard M.Kastelic MD and Associates | Johnstown | Pennsylvania | United States | 15905 |
| 81 | Green and Seidner Family Practice Associates | Lansdale | Pennsylvania | United States | 19446 |
| 82 | Center for Medical Research, LLC | Providence | Rhode Island | United States | 02908 |
| 83 | DeGarmo Institute Of Medical Research | Greer | South Carolina | United States | 29650 |
| 84 | Health Concepts | Rapid City | South Dakota | United States | 57702 |
| 85 | PMG Research of Bristol, LLC - State | Bristol | Tennessee | United States | 37620 |
| 86 | New Phase Research & Development - Knoxville | Knoxville | Tennessee | United States | 37909 |
| 87 | Clinical Research Solutions - Smyrna, TN | Smyrna | Tennessee | United States | 37167 |
| 88 | Health Innovation Research Group | Arlington | Texas | United States | 76014 |
| 89 | DCT-AACT, LLC, dba Discovery Clinical Trials | Austin | Texas | United States | 78758 |
| 90 | Inquest Clinical Research | Baytown | Texas | United States | 77521 |
| 91 | Protenium Clinical Research, LLC - Dallas | Dallas | Texas | United States | 75208 |
| 92 | VA North Texas Health Care System - Dallas VA Medical Center (DVAMC) | Dallas | Texas | United States | 75216 |
| 93 | Academy of Diabetes, Thyroid and Endocrine, P.A. | El Paso | Texas | United States | 79935 |
| 94 | Juno Research, LLC - Northwest Site | Houston | Texas | United States | 77040 |
| 95 | Centex Studies, Inc. | Houston | Texas | United States | 77058 |
| 96 | Juno Research, LLC - Southwest Houston Site | Houston | Texas | United States | 77074 |
| 97 | Pioneer Research Solutions Inc. | Houston | Texas | United States | 77099 |
| 98 | Grace Research, LLC - Huntsville, TX | Huntsville | Texas | United States | 77340 |
| 99 | Protenium Clinical Research, LLC | Hurst | Texas | United States | 76054 |
| 100 | Juno Research, LLC - Katy | Katy | Texas | United States | 77450 |
| 101 | FMC Science | Lampasas | Texas | United States | 76550 |
| 102 | DCT - McAllen Primary Care, LLC | McAllen | Texas | United States | 78503 |
| 103 | San Antonio Premier Internal Medicine | San Antonio | Texas | United States | 78220 |
| 104 | Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute | San Antonio | Texas | United States | 78228 |
| 105 | Pinnacle Clinical Research | San Antonio | Texas | United States | 78229 |
| 106 | Bandera Family HealthCare Research, LLC (BFHC) | San Antonio | Texas | United States | 78249 |
| 107 | Manassas Clinical Research Center | Manassas | Virginia | United States | 20110 |
| 108 | York Clinical Research LLC | Norfolk | Virginia | United States | 23510 |
| 109 | Exemplar Research Inc. - Fairmont, WV | Morgantown | West Virginia | United States | 26505 |
| 110 | Allegiance Research Specialists, LLC | Wauwatosa | Wisconsin | United States | 53226 |
| 111 | Brest Regional Hospital | Brest | Belarus | ||
| 112 | Gomel Regional Clinical Center of Cardiology | Gomel | Belarus | ||
| 113 | Gomel Regional Clinical Hospital | Gomel | Belarus | ||
| 114 | Grodno University Hospital | Grodno | Belarus | ||
| 115 | City Clinical Hospital #10 | Minsk | Belarus | ||
| 116 | City Clinical Hospital #1 | Minsk | Belarus | ||
| 117 | Minsk Regional Clinical Hospital | Minsk | Belarus | ||
| 118 | Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology | Minsk | Belarus | ||
| 119 | Mogilev Regional Medical and Diagnostic Center | Mogilev | Belarus | ||
| 120 | Vitebsk Regional Clinical Hospital | Vitebsk | Belarus | ||
| 121 | Medical Center Diamedical 2013 OOD | Dimitrovgrad | Bulgaria | ||
| 122 | University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- First Cardiology Clinic | Pleven | Bulgaria | ||
| 123 | University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- Second Cardiology Clinic | Pleven | Bulgaria | ||
| 124 | UMHAT Sveti Georgi - Clinic of Cardiology | Plovdiv | Bulgaria | ||
| 125 | MHAT Dr. Bratan Shukjerov | Smolyan | Bulgaria | ||
| 126 | Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD | Smolyan | Bulgaria | ||
| 127 | Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Cardiology | Sofia | Bulgaria | ||
| 128 | Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Endocrinology and Meteorism Diseases | Sofia | Bulgaria | ||
| 129 | Medical Center Orfey OOD | Stara Zagora | Bulgaria | ||
| 130 | Lipidova poradna | Bilina | Czechia | ||
| 131 | Medicus Services SRO | Brandýs nad Labem | Czechia | ||
| 132 | Fakultni nemocnice Hradec Kralove, Klinika gerontologicka a metabolicka | Hradec Kralove | Czechia | ||
| 133 | Ordinace pro choroby srdce a cev | Praha 10 | Czechia | ||
| 134 | Vseobecna fakultni nemocnice v Praze | Praha 2 | Czechia | ||
| 135 | Onkologicka klinika 2. LF UK a FN Motol | Praha 5 | Czechia | ||
| 136 | Oblastni nemocnice Trutnov, Oddeleni klinicke biochemie | Trutnov | Czechia | ||
| 137 | MUDr. Nina Zemkova s.r.o. Interni Ambulance | Uherské Hradište | Czechia | ||
| 138 | Unimed Ajara LLC | Batumi | Georgia | ||
| 139 | Clinic LJ Ltd | Kutaisi | Georgia | ||
| 140 | Aleksandre Aladashvili Clinic - LLC | Tbilisi | Georgia | ||
| 141 | Archangel St Michael Multiprofile Clinical Hospital Ltd | Tbilisi | Georgia | ||
| 142 | Emergency Cardiology Center by Academician G. Chapidze Ltd | Tbilisi | Georgia | ||
| 143 | Institute of Clinical Cardiology Ltd | Tbilisi | Georgia | ||
| 144 | Unimed Kakheti - Caraps Medline LLC | Tbilisi | Georgia | ||
| 145 | Unimed Kakheti - Telavi Referral Hospital LLC | Telavi | Georgia | ||
| 146 | DRC Gyogyszervizsgalo Kozpont Kft | Balatonfüred | Hungary | ||
| 147 | DRC Balatongyorok | Balatongyorok | Hungary | ||
| 148 | Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo | Bekescsaba | Hungary | ||
| 149 | Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly | Budapest | Hungary | ||
| 150 | Magyar Honvedseg Egeszsegugyi Kozpont | Budapest | Hungary | ||
| 151 | Debreceni Egyetem Klinikai Kozpont | Debrecen | Hungary | ||
| 152 | BKS Research Kft. | Hatvan | Hungary | ||
| 153 | Pecsi Tudomanyegyetem Klinikai Kozpont I.sz. Belgyogyaszati Klinika | Pecs | Hungary | ||
| 154 | Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz | Szekesfehervar | Hungary | ||
| 155 | Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii, lek. med. Krzysztof Cymerman | Gdynia | Poland | ||
| 156 | SALVIA Lekston i Madej s.j. | Katowice | Poland | ||
| 157 | Malopolskie Centrum Alergii i Immunoterapii Allmedis SP Z O O | Krakow | Poland | ||
| 158 | AppleTreeClinics Sp. z o.o. | Lodz | Poland | ||
| 159 | NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek | Lodz | Poland | ||
| 160 | Nzoz Salusmed | Lodz | Poland | ||
| 161 | MEDICOME Sp. z o.o. | Oswiecim | Poland | ||
| 162 | Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne OMEGA SP Z O O | Plock | Poland | ||
| 163 | Centrum Zdrowia Metabolicznego Pawel Bogdanski | Poznan | Poland | ||
| 164 | Praktyka Lekarska Ewa Krzyzagorska | Poznan | Poland | ||
| 165 | Clinmedica Research Omc Sp z o.o. Sp | Skierniewice | Poland | ||
| 166 | Centrum Kardiologiczne Pro Corde Sp. z o. o. | Wroclaw | Poland | ||
| 167 | City Clinical Hospital n.a. M.P. Konchalovskiy | Zelenograd | Moscow | Russian Federation | |
| 168 | First City Clinical Hospital n.a. E.E.Volosevich | Arkhangelsk | Russian Federation | ||
| 169 | Northern Medical Clinical Center named after N.A. Semashko of the Federal Medical and Biological Agency | Arkhangelsk | Russian Federation | ||
| 170 | Altay Regional Cardiology Dispensary, Cardiology Department for Patients with Acute Myocardial Infarction | Barnaul | Russian Federation | ||
| 171 | Chita State Medical Academy | Chita | Russian Federation | ||
| 172 | Ural State Medical University based at Central City Clinical Hospital No.1 of Oktyabrskiy District | Ekaterinburg | Russian Federation | ||
| 173 | Interregional Clinical Diagnostic Center | Kazan | Russian Federation | ||
| 174 | Kazan State Medical University based at City Clinical Hospital #7 | Kazan | Russian Federation | ||
| 175 | Federal State Budget Institution "Scientific-Research Institute of Complex Problems of Cardiovascular Diseases" | Kemerovo | Russian Federation | ||
| 176 | Medical Center "Alliance" | Kirovsk | Russian Federation | ||
| 177 | Krasnoyarsk State Medical University n.a. prof. V.F. Voino-Yasenetsky | Krasnoyarsk | Russian Federation | ||
| 178 | Central Clinical Hospital of Russian Academy of Sciences | Moscow | Russian Federation | ||
| 179 | City Clinical Hospital #15 n.a. O.M. Filatov | Moscow | Russian Federation | ||
| 180 | City Clinical Hospital n.a. M.E. Zhadkevich of Moscow Healthcare Department | Moscow | Russian Federation | ||
| 181 | Federal State Budget Institution "Outpatient Clinic #3" of Russian Federation President's Management Department | Moscow | Russian Federation | ||
| 182 | National Medical Research Center of Cardiology - Department of Atherosclerosis | Moscow | Russian Federation | ||
| 183 | National Medical Research Center of Cardiology | Moscow | Russian Federation | ||
| 184 | National Medical Research Center of Preventive Medicine | Moscow | Russian Federation | ||
| 185 | Non-governmental Private Healthcare Institution "Scientific Clinical Centre of Open Joint-Stock Company Russian Railways" (JSC "RZD") | Moscow | Russian Federation | ||
| 186 | City Clinical Hospital No.2 | Novosibirsk | Russian Federation | ||
| 187 | RC Medical LLC | Novosibirsk | Russian Federation | ||
| 188 | Research Institute of Physiology and Fundamental Medicine | Novosibirsk | Russian Federation | ||
| 189 | Orenburg State Medical University based at City Clinical Hospital #1 | Orenburg | Russian Federation | ||
| 190 | Clinical-diagnostic center "Zdorovye" | Rostov-on-Don | Russian Federation | ||
| 191 | Rostov-on-Don City Hospital of Emergency Care | Rostov-on-Don | Russian Federation | ||
| 192 | Almazov National Medical Research Centre, Scientific Laboratory of Electrocardiology | Saint Petersburg | Russian Federation | ||
| 193 | BioTechService LLC | Saint Petersburg | Russian Federation | ||
| 194 | Clinic Complex JSC | Saint Petersburg | Russian Federation | ||
| 195 | Limited Liability Company "MedPomosch" | Saint Petersburg | Russian Federation | ||
| 196 | Medical Technologies LLC | Saint Petersburg | Russian Federation | ||
| 197 | North-Western State Medical University named after I.I. Mechnikov | Saint Petersburg | Russian Federation | ||
| 198 | City hospital #38 n.a. N.A. Semashko | Saint-Petersburg | Russian Federation | ||
| 199 | Regional Clinical Cardiology Dispensary | Saratov | Russian Federation | ||
| 200 | Saratov State Medical University n. a. V.I. Razumovsky | Saratov | Russian Federation | ||
| 201 | Saint-Petersburg State Budget Healthcare Institution "City Pokrovskaya Hospital", Cardiology Departmen | St-Petersburg | Russian Federation | ||
| 202 | Almazov National Medical Research Centre | St. Petersburg | Russian Federation | ||
| 203 | Clinical Hospital #122 n. a. L.G. Sokolov of the Federal Medical Biological Agency | St. Petersburg | Russian Federation | ||
| 204 | Consultative Diagnostic Center with Out-patient Clinic | St. Petersburg | Russian Federation | ||
| 205 | Tomsk National Research Medical Center of Russian Academy of Sciences | Tomsk | Russian Federation | ||
| 206 | Autonomous Institution of healthcare of the Voronezh region "Voronezh regional clinical consultative and diagnostic centre | Voronezh | Russian Federation | ||
| 207 | Yaroslavl Regional Clinical Hospital for War Veterans - International Center on the Problems of the Elderly "Zdorovoe Dolgoletie" | Yaroslavl | Russian Federation | ||
| 208 | Ivano-Frankivsk Regional Clinical Cardiological Dispensary, Chronic Ischaemic Heart Disease Department | Ivano-Frankivsk | Ukraine | ||
| 209 | JSC "Ukrainian Railways" Kharkiv Railway Clinical Hospital#1 of Branch "Healthcare Center" of PJSC "Ukrainian Railways", Cardiology Depart #1 | Kharkiv | Ukraine | ||
| 210 | JSC "Ukrainian Railways" Kharkiv Railway Clinical Hospital#1 of Branch "Healthcare Center" of PJSC "Ukrainian Railways", Cardiology Depart #2 | Kharkiv | Ukraine | ||
| 211 | Municipal Non-Commercial Enterprise "City Clinical Emergency Hospital n.a. prof. O.I. Meshchaninov" of Kharkiv City Council | Kharkiv | Ukraine | ||
| 212 | Municipal Noncommercial Enterprise "City Clinical Hospital #27" of Kharkiv City Council | Kharkiv | Ukraine | ||
| 213 | Municipal Noncommercial Enterprise "City Outpatient Clinic #9" of Kharkiv City Council | Kharkiv | Ukraine | ||
| 214 | Kyiv City Clinical Hospital #1, Urgent Cardiology Department | Kyiv | Ukraine | ||
| 215 | Limited Liability Company "Treatment and Diagnostic Center "Adonis Plus"", Outpatient Department | Kyiv | Ukraine | ||
| 216 | 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 | Ukraine | ||
| 217 | SI "Institute of Gerontology n.a. D.F.Chebotarev NAMS of Ukraine", Cardiol. Un. of Clin. Physiology and Int. Organs Path. Dep-t | Kyiv | Ukraine | ||
| 218 | Municipal Institution "City Clinical Hospital #3 n.a. prof. L.J. Aleinikova", Cardiology Intensive Therapy Department | Odesa | Ukraine | ||
| 219 | Small Private Enterprise, Medical Centre "Puls" | Vinnytsya | Ukraine | ||
| 220 | Municipal Institution "City Clinical Hospital #6", Therapeutic Department | Zaporizhzhia | Ukraine |
Sponsors and Collaborators
- Kowa Research Institute, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT03001817
Other Study ID Numbers:
- K-877-301
First Posted:
Dec 23, 2016
Last Update Posted:
May 1, 2020
Last Verified:
Apr 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: