- * Age at least 18 years or greater
- * Symptomatic low ejection fraction heart failure (weak heart muscle)
- * Receiving any dose of a beta blocker for the treatment of HF (unless not able to tolerate)
- * Kidney function not more than mild or moderately impaired
- * High blood potassium (\>5.0 mEq/L) currently while receiving medications for heart failure OR normal blood potassium currently but previously had high potassium in the12 months prior to screening which caused a permanent reduction or discontinuation of heart failure medications
- * Hospitalization for heart failure or treatment in an out patient setting with intravenous medications within the last 12 months before screening.
Hyperkalemia
Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)
NCT03888066 | PHASE 3 | INTERVENTIONAL
The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.
Trial Information
If interested, contact clinicaltrials@cslbehring.com for more information
CSL Behring respects your privacy. For an explanation of how CSL Behring will use the information you are submitting, please view our Privacy Policy
Investigator Site
Alexander City,Alabama,United States,35010
Investigator Site
Huntsville,Alabama,United States,35801
Investigator Site
Phoenix,Arizona,United States,85108
Investigator Site
Tucson,Arizona,United States,85724
Investigator Site
Bakersfield,California,United States,93308
Investigator Site
Fremont,California,United States,94538
Investigator Site
Fresno,California,United States,93720
Investigator Site
Huntington Beach,California,United States,92648
Investigator Site
La Jolla,California,United States,92037
Investigator Site
La Mesa,California,United States,91942
Investigator Site
Laguna Hills,California,United States,92653
Investigator Site
Long Beach,California,United States,90813
Investigator Site
Northridge,California,United States,91324
Investigator Site
Pasadena,California,United States,91105
Investigator Site
Sacramento,California,United States,95816
Investigator Site
San Diego,California,United States,92119
Investigator Site
San Diego,California,United States,92161
Investigator Site
Santa Ana,California,United States,92705
Investigator Site
Stockton,California,United States,95204
Investigator Site
Thousand Oaks,California,United States,91360
Investigator Site
Van Nuys,California,United States,91401
Investigator Site
West Hills,California,United States,91307
Investigator Site
Aurora,Colorado,United States,80045
Investigator Site
Altamonte Springs,Florida,United States,32701
Investigator Site
Boynton Beach,Florida,United States,33437
Investigator Site
Brandon,Florida,United States,33511
Investigator Site
Doral,Florida,United States,33166
Investigator Site
Gainesville,Florida,United States,32608
Investigator Site
Greenacres City,Florida,United States,33467
Investigator Site
Homestead,Florida,United States,33033
Investigator Site
Jacksonville,Florida,United States,32224
Investigator Site
Jacksonville,Florida,United States,32277
Investigator Site
Medley,Florida,United States,33166
Research Site
Miami Lakes,Florida,United States,33014
Research Site
Miami Lakes,Florida,United States,33014
Investigator Site
Miami,Florida,United States,33125
Investigator Site
Miami,Florida,United States,33144
Investigator Site
Miami,Florida,United States,33155
Investigator Site
North Miami Beach,Florida,United States,33169
Investigator Site
Orlando,Florida,United States,32807
Investigator Site
Orlando,Florida,United States,32810
Investigator Site
Orlando,Florida,United States,32819
Investigator Site
Pembroke Pines,Florida,United States,33026
Investigator Site
Pompano Beach,Florida,United States,33064
Investigator Site
Tamarac,Florida,United States,33321
Investigator Site
Tampa,Florida,United States,33606
Investigator Site
Tampa,Florida,United States,33614
Investigator Site
Atlanta,Georgia,United States,30303
Investigator Site
Columbus,Georgia,United States,31904
Investigator Site
Macon,Georgia,United States,31201
Investigator Site
Arlington Heights,Illinois,United States,60005
Investigator Site
Hazel Crest,Illinois,United States,60429
Investigator Site
Peoria,Illinois,United States,61602
Investigator Site
Peoria,Illinois,United States,61614
Investigator Site
Merrillville,Indiana,United States,46410
Investigator Site
Munster,Indiana,United States,46321
Investigator Site
Richmond,Indiana,United States,47347
Investigator Site
Owensboro,Kentucky,United States,42303
Investigator Site
Opelousas,Louisiana,United States,70570
Investigator Site
West Monroe,Louisiana,United States,71291
Investigator Site
Baltimore,Maryland,United States,21229
Investigator Site
Columbia,Maryland,United States,21044
Investigator Site
Boston,Massachusetts,United States,02215
Investigator Site
Detroit,Michigan,United States,48201
Investigator Site
Livonia,Michigan,United States,48154
Investigator Site
Rochester,Michigan,United States,48307
Investigator Site
Rochester,Michigan,United States,48307
Investigator Site
Jackson,Mississippi,United States,39216
Investigator Site
Kansas City,Missouri,United States,64111
Investigator Site
Saint Louis,Missouri,United States,63110
Investigator Site
Lincoln,Nebraska,United States,68256
Investigator Site
Las Vegas,Nevada,United States,89102
Investigator Site
North Las Vegas,Nevada,United States,89086
Investigator Site
Haddon Heights,New Jersey,United States,08035
Investigator Site
Linden,New Jersey,United States,07036
Investigator Site
New Brunswick,New Jersey,United States,08901
Investigator Site
Newark,New Jersey,United States,07102
Investigator Site
Albuquerque,New Mexico,United States,87109
Investigator Site
Bronx,New York,United States,10461
Investigator Site
Brooklyn,New York,United States,11203
Investigator Site
Brooklyn,New York,United States,11234
Investigator Site
Buffalo,New York,United States,14215
Investigator Site
Manhasset,New York,United States,11030
Investigator Site
Richmond Hill,New York,United States,11419
Investigator Site
Staten Island,New York,United States,10310
Investigator Site
Stony Brook,New York,United States,11794
Investigator Site
Charlotte,North Carolina,United States,28204
Investigator Site
Charlotte,North Carolina,United States,28207
Investigator Site
Greenville,North Carolina,United States,27834
Investigator Site
Lumberton,North Carolina,United States,28358
Investigator Site
Columbus,Ohio,United States,43214
Investigator Site
Lorain,Ohio,United States,44053
Investigator Site
Marion,Ohio,United States,43302
Investigator Site
Toledo,Ohio,United States,43623
Investigator Site
Bartlesville,Oklahoma,United States,74006
Investigator Site
Oklahoma City,Oklahoma,United States,73112
Investigator Site
Hillsboro,Oregon,United States,97123
Investigator Site
Portland,Oregon,United States,97239
Investigator Site
Erie,Pennsylvania,United States,16507
Investigator Site
Hershey,Pennsylvania,United States,17033
Investigator Site
Greenville,South Carolina,United States,29607
Investigator Site
Greenwood,South Carolina,United States,29646
Investigator Site
Lancaster,South Carolina,United States,29720
Investigator Site
Rock Hill,South Carolina,United States,29732
Investigator Site
Chattanooga,Tennessee,United States,37403
Investigator Site
Jackson,Tennessee,United States,38301
Investigator Site
Memphis,Tennessee,United States,38117
Investigator Site
Memphis,Tennessee,United States,38138
Investigator Site
Tullahoma,Tennessee,United States,37388
Investigator Site
Allen,Texas,United States,75013
Investigator Site
Allen,Texas,United States,75013
Investigator Site
Amarillo,Texas,United States,79106
Investigator Site
Dallas,Texas,United States,75231
Investigator Site
Dallas,Texas,United States,75246
Investigator Site
Denison,Texas,United States,75020
Investigator Site
Fort Worth,Texas,United States,76104
Investigator Site
Gonzales,Texas,United States,78629
Investigator Site
Houston,Texas,United States,77002
Investigator Site
Houston,Texas,United States,77070
Investigator Site
Houston,Texas,United States,77077
Investigator Site
Houston,Texas,United States,77094
Investigator Site
Katy,Texas,United States,77450
Investigator Site
Lampasas,Texas,United States,76550
Investigator Site
McKinney,Texas,United States,75071
Investigator Site
San Antonio,Texas,United States,78215
Investigator Site
San Antonio,Texas,United States,78229
Investigator Site
Sugar Land,Texas,United States,77479
Investigator Site
Webster,Texas,United States,77598
Investigator Site
Salt Lake City,Utah,United States,84132
Investigator Site
Norfolk,Virginia,United States,23507
Investigator Site
Norfolk,Virginia,United States,23510
Investigator Site
Morgantown,West Virginia,United States,26506
Investigator Site
Milwaukee,Wisconsin,United States,53226
Investigator Site
Ciudad Autonoma de Buenos Aire,Buenos Aires,Argentina,C1093AAS
Investigator Site
Ciudadela,Buenos Aires,Argentina,B1702BML
Investigator Site
Ramos Mejía,Buenos Aires,Argentina,B1704ETD
Investigator Site
San Nicolás,Buenos Aires,Argentina,B2900DPA
Investigator Site
Córdoba,Cordoba,Argentina,5000
Investigator Site
Córdoba,Cordoba,Argentina,X5000EVQ
Investigator Site
Córdoba,Cordoba,Argentina,X5002AOQ
Investigator Site
Villa María,Cordoba,Argentina,5900
Investigator Site
Mar Del Plata,Provincia De Buenos Aires,Argentina,B7602CBM
Investigator Site
San Miguel De Tucumán,Tucuman,Argentina,4000
Investigator Site
Ciudad Autonoma de Buenos Aires,Argentina,1425
Investigator Site
Ciudad Autonoma de Buenos Aires,Argentina,C1023AAB
Investigator Site
Ciudad Autonoma de Buenos Aires,Argentina,C1407GTN
Investigator Site
Ciudad Autonoma de Buenos Aires,Argentina,C1430CKE
Investigator Site
Salta,Argentina,A4406BPF
Investigator Site
San Luis,Argentina,5700
Investigator Site
Santa Fe,Argentina,3000
Investigator Site
Mechelen,Antwerp,Belgium,2800
Investigator Site
Ghent,Oost Vlaanderen,Belgium,9000
Investigator Site
Aalst,Belgium,B-9300
Investigator Site
Brussels,Belgium,1200
Investigator Site
Genk,Belgium,3600
Investigator Site
Hasselt,Belgium,3500
Investigator Site
Leuven,Belgium,3000
Investigator Site
Liège,Belgium,4000
Investigator Site
Roeselare,Belgium,8800
Investigator Site
Yvoir,Belgium,5530
Investigator Site
Salvador,Bahia,Brazil,40170-130
Investigator Site
Fortaleza,Ceará,Brazil,60430-370
Investigator Site
Fortaleza,Ceará,Brazil,60840-285
Investigator Site
Brasília,Distrito Federal,Brazil,70710-100
Investigator Site
Vitória,Espirito Santo,Brazil,29043-260
Investigator Site
Belo Horizonte,Minas Gerais,Brazil,30110-934
Investigator Site
Belo Horizonte,Minas Gerais,Brazil,30150-240
Investigator Site
Uberlândia,Minas Gerais,Brazil,38411-186
Investigator Site
Campina Grande Do Sul,Paraná,Brazil,83430-000
Investigator Site
Canoas,Rio Grande Do Sul,Brazil,92425-900
Investigator Site
Porto Alegre,Rio Grande Do Sul,Brazil,90840-440
Investigator Site
Porto Alegre,RS,Brazil,90020-090
Investigator Site
Porto Alegre,RS,Brazil,90035-903
Investigator Site
Porto Alegre,RS,Brazil,90620-001
Investigator Site
Porto Alegre,RS,Brazil,91350-200
Investigator Site
Blumenau,SC,Brazil,89020-430
Investigator Site
Aracaju,Sergipe,Brazil,49055-530
Investigator Site
Campinas,São Paulo,Brazil,13083-970
Investigator Site
Ribeirão Preto,São Paulo,Brazil,14051-140
Investigator Site
São José Do Rio Preto,São Paulo,Brazil,15015-210
Investigator Site
Rio De Janeiro,Brazil,20241-180
Investigator Site
São Paulo,Brazil,05403-000
Investigator Site
São Paulo,Brazil,09080-110
Investigator Site
Burgas,Bulgaria,8000
Investigator Site
Pleven,Bulgaria,5800
Investigator Site
Plovdiv,Bulgaria,4002
Investigator Site
Ruse,Bulgaria,7002
Investigator Site
Sofia,Bulgaria,1233
Investigator Site
Sofia,Bulgaria,1379
Investigator Site
Sofia,Bulgaria,1431
Investigator Site
Sofia,Bulgaria,1527
Investigator Site
Winnipeg,Manitoba,Canada,R2H2A6
Investigator Site
Saint John's,Newfoundland and Labrador,Canada,A1B3V6
Investigator Site
Cambridge,Ontario,Canada,N1R7R1
Investigator Site
London,Ontario,Canada,N6A5A5
Investigator Site
Newmarket,Ontario,Canada,L3Y2P6
Investigator Site
Toronto,Ontario,Canada,M5B1W8
Investigator Site
Greenfield Park,Quebec,Canada,J4V2G8
Investigator Site
Sherbrooke,Quebec,Canada,J1G2E8
Investigator Site
Trois-Rivières,Quebec,Canada,G8Z3R9
Investigator Site
Brno,Czechia,65691
Investigator Site
Bílina,Czechia,41801
Investigator Site
Havlíčkův Brod,Czechia,58022
Investigator Site
Havířov,Czechia,73601
Investigator Site
Liberec,Czechia,46001
Investigator Site
Litovel,Czechia,78401
Investigator Site
Mariánské Lázně,Czechia,35301
Investigator Site
Náchod,Czechia,54701
Investigator Site
Praha,Czechia,12808
Investigator Site
Praha,Czechia,14059
Investigator Site
Praha,Czechia,16902
Investigator Site
Slaný,Czechia,27401
Investigator Site
Uherské Hradiště,Czechia,68601
Investigator Site
Bordeaux,France,33075
Investigator Site
La Tronche,France,38700
Investigator Site
Lille,France,59000
Investigator Site
Lyon,France,76000
Investigator Site
Montpellier,France,34295
Investigator Site
Nancy,France,54500
Investigator Site
Paris,France,75010
Investigator Site
Paris,France,75013
Investigator Site
Paris,France,75013
Investigator Site
Paris,France,75018
Investigator Site
Pau,France,64000
Investigator Site
Poitiers,France,86021
Investigator Site
Reims,France,51092
Investigator Site
Rouen,France,76031
Investigator Site
Saint-Brieuc,France,22000
Investigator Site
Toulon,France,83100
Investigator Site
Toulouse,France,31400
Investigator Site
Tourcoing,France,59200
Investigator Site
Valenciennes,France,59300
Investigator Site
Valenciennes,France,59300
Investigator Site
Batumi,Georgia,6004
Investigator Site
Tbilisi,Georgia,0102
Investigator Site
Tbilisi,Georgia,0112
Investigator Site
Tbilisi,Georgia,0131
Investigator Site
Tbilisi,Georgia,0159
Investigator Site
Tbilisi,Georgia,0159
Investigator Site
Tbilisi,Georgia,0159
Investigator Site
Tbilisi,Georgia,0159
Investigator Site
Tbilisi,Georgia,0167
Investigator Site
Tbilisi,Georgia,0172
Investigator Site
Tbilisi,Georgia,0180
Investigator Site
Tbilisi,Georgia,0186
Investigator Site
Coburg,Bavarian,Germany,96450
Investigator Site
Greifswald,Mecklenburg-Vorpommern,Germany,17475
Investigator Site
Homburg,Saar,Germany,D-66421
Investigator Site
Bad Oeynhausen,Germany,32545
Investigator Site
Berlin,Germany,10789
Investigator Site
Berlin,Germany,12559
Investigator Site
Bielefeld,Germany,33604
Investigator Site
Bremen,Germany,28277
Investigator Site
Erfurt,Germany,99097
Investigator Site
Essen,Germany,45138
Investigator Site
Frankfurt,Germany,60590
Investigator Site
Frankfurt,Germany,65929
Investigator Site
Gießen,Germany,35392
Investigator Site
Halle,Germany,06120
Investigator Site
Hamburg,Germany,20246
Investigator Site
Hanover,Germany,30625
Investigator Site
Heilbronn,Germany,74177
Investigator Site
Kiel,Germany,24105
Investigator Site
Leipzig,Germany,04103
Investigator Site
Leverkusen,Germany,51375
Investigator Site
Minden,Germany,32429
Investigator Site
Nürnberg,Germany,90402
Investigator Site
Würzburg,Germany,97078
Investigator Site
Budapest,Hungary,1096
Investigator Site
Budapest,Hungary,1097
Investigator Site
Budapest,Hungary,1122
Investigator Site
Budapest,Hungary,1134
Investigator Site
Kecskemét,Hungary,6000
Investigator Site
Kistarcsa,Hungary,2143
Investigator Site
Nyiregyhaza,Hungary,4400
Investigator Site
Ashqelon,Israel,78278
Investigator Site
Be'er Ya'aqov,Israel,6093000
Investigator Site
Hadera,Israel,3810101
Investigator Site
Haifa,Israel,3109601
Investigator Site
Haifa,Israel,3109601
Investigator Site
H̱olon,Israel,98100
Investigator Site
Jerusalem,Israel,9103102
Investigator Site
Jerusalem,Israel,91120
Investigator Site
Jerusalem,Israel,91240
Investigator Site
Nahariya,Israel,2210001
Investigator Site
Petah tikva,Israel,4941492
Investigator Site
Ramat Gan,Israel,5265601
Investigator Site
Safed,Israel,13100
Investigator Site
Tiberias,Israel,1520800
Investigator Site
Ancona,Italy
Investigator Site
Bergamo,Italy,24127
Investigator Site
Brescia,Italy,25123
Investigator Site
Caserta,Italy,81100
Investigator Site
Cona,Italy,44120
Investigator Site
Foggia,Italy,71100
Investigator Site
Genova,Italy,16132
Investigator Site
Milano,Italy,20138
Investigator Site
Piacenza,Italy,29121
Investigator Site
Roma,Italy,00163
Investigator Site
San Bonifacio,Italy,37047
Investigator Site
Cuauhtémoc,Ciudad De Mexico,Mexico,06090
Investigator Site
Delegación Gustavo A. Madero,Ciudad De Mexico,Mexico,07020
Investigator Site
Guadalajara,Jalisco,Mexico,44100
Investigator Site
Guadalajara,Jalisco,Mexico,44657
Investigator Site
San Pedro Garza Garcia,Nuevo Léon,Mexico,66278
Investigator Site
Oaxaca de Juarez,Oaxaca,Mexico,6800
Investigator Site
Santiago De Querétaro,Querétaro,Mexico,76000
Investigator Site
Culiacán,Sinaloa,Mexico,80230
Investigator Site
Xalapa,Veracruz,Mexico,91193
Investigator Site
Rotterdam,South Holland,Netherlands,3000
Investigator Site
's-Hertogenbosch,Netherlands,5223GZ
Investigator Site
Amstelveen,Netherlands,1186AM
Investigator Site
Blaricum,Netherlands,1261AN
Investigator Site
Dirksland,Netherlands,3247BW
Investigator Site
Dordrecht,Netherlands,3318AT
Investigator Site
Ede,Netherlands,6716RP
Investigator Site
Groningen,Netherlands,9713GZ
Investigator Site
Helmond,Netherlands,5707HA
Investigator Site
Hoorn,Netherlands,1624NP
Investigator Site
Schiedam,Netherlands,3118JH
Investigator Site
Tilburg,Netherlands,5042AD
Investigator Site
Utrecht,Netherlands,3582KE
Investigator Site
Białystok,Poland,15-276
Investigator Site
Katowice,Poland,40-156
Investigator Site
Kędzierzyn-Koźle,Poland,47-200
Investigator Site
Olsztyn,Poland,10-010
Investigator Site
Ostrowiec Świętokrzyski,Poland,27-400
Investigator Site
Pomorskie,Poland,81-717
Investigator Site
Poznań,Poland,61-485
Investigator Site
Poznań,Poland,61-848
Investigator Site
Rzeszów,Poland,35-055
Investigator Site
Wrocław,Poland,50-556
Investigator Site
Wrocław,Poland,51-162
Investigator Site
Zgierz,Poland,95-100
Investigator Site
Łódź,Poland,90-549
Investigator Site
Łódź,Poland,93-513
Investigator Site
Izhevsk,Udmurt Republic,Russian Federation,426063
Investigator Site
Chelyabinsk,Russian Federation,454136
Investigator Site
Ekaterinburg,Russian Federation,620109
Investigator Site
Kazan,Russian Federation,420033
Investigator Site
Kemerovo,Russian Federation,650002
Investigator Site
Moscow,Russian Federation,111539
Investigator Site
Moscow,Russian Federation,119192
Investigator Site
Moscow,Russian Federation,119192
Investigator Site
Moscow,Russian Federation,124489
Investigator Site
Novosibirsk,Russian Federation,63008
Investigator Site
Penza,Russian Federation,440026
Investigator Site
Perm,Russian Federation,614097
Investigator Site
Petrozavodsk,Russian Federation,185019
Investigator Site
Ryazan',Russian Federation,390039
Investigator Site
Saint Petersburg,Russian Federation,198205
Investigator Site
Saint Petersburg,Russian Federation,199106
Investigator Site
Tver,Russian Federation,170036
Investigator Site
Belgrade,Serbia,11000
Investigator Site
Belgrade,Serbia,11040
Investigator Site
Belgrade,Serbia,11050
Investigator Site
Belgrade,Serbia,11080
Investigator Site
Niška Banja,Serbia,18205
Investigator Site
Niš,Serbia,18000
Investigator Site
Sremska Kamenica,Serbia,21204
Investigator Site
Šabac,Serbia,15000
Investigator Site
Palma De Mallorca,Baleares,Spain,07120
Investigator Site
Castellón De La Plana,Castellon,Spain,12004
Investigator Site
Barcelona,Cataluña,Spain,08003
Investigator Site
Santiago De Compostela,La Coruña,Spain,015706
Investigator Site
Majadahonda,Madrid,Spain,28222
Investigator Site
Marbella,Malaga,Spain,029603
Investigator Site
La Laguna,Tenerife,Spain,038320
Investigator Site
Manises,Valencia,Spain,46940
Investigator Site
Alicante,Spain,03010
Investigator Site
Badalona,Spain,08916
Investigator Site
Barcelona,Spain,08041
Investigator Site
Barcelona,Spain,08907
Investigator Site
Huelva,Spain,021005
Investigator Site
La Coruña,Spain
Investigator Site
Lleida,Spain,25198
Investigator Site
Madrid,Spain,028007
Investigator Site
Madrid,Spain,028041
Investigator Site
Madrid,Spain,28006
Investigator Site
Madrid,Spain,28034
Investigator Site
Madrid,Spain,28040
Investigator Site
Murcia,Spain,300008
Investigator Site
Málaga,Spain,29010
Investigator Site
Sevilla,Spain,041007
Investigator Site
Valencia,Spain,046020
Investigator Site
Valencia,Spain,4610
Investigator Site
Kharkiv,Novobavarskiy,Ukraine,61157
Investigator Site
Dnipro,Ukraine,49027
Investigator Site
Ivano-Frankivs'k,Ukraine,76008
Investigator Site
Ivano-Frankivs'k,Ukraine,76018
Investigator Site
Kharkiv,Ukraine,61039
Investigator Site
Kharkiv,Ukraine,61058
Investigator Site
Kharkiv,Ukraine,61103
Investigator Site
Kharkiv,Ukraine,61176
Investigator Site
Kyiv,Ukraine,01601
Investigator Site
Kyiv,Ukraine,0200
Investigator Site
Kyiv,Ukraine,02166
Investigator Site
Kyiv,Ukraine,03110
Investigator Site
Kyiv,Ukraine,04050
Investigator Site
Lviv,Ukraine,79013
Investigator Site
Vinnytsia,Ukraine,21000
Investigator Site
Zaporizhzhya,Ukraine,69106
Investigator Site
Zhytomyr,Ukraine,10002
Investigator Site
Harlow,Essex,United Kingdom,CM201QX
Investigator Site
Scunthorpe,North Lincolshire,United Kingdom,DN157BH
Investigator Site
Dudley,West Midlands,United Kingdom,DY12HQ
Investigator Site
Barnsley,United Kingdom,S752EP
Investigator Site
High Wycombe,United Kingdom,HP112TT
Investigator Site
Inverness,United Kingdom,IV23JH
Investigator Site
Leicester,United Kingdom,LE39QP
Investigator Site
Liverpool,United Kingdom,L97AL
Investigator Site
London,United Kingdom,SE59RS
Investigator Site
North Shields,United Kingdom,NE298NH
Investigator Site
Swansea,United Kingdom,SA66NL
Investigator Site
York,United Kingdom,YO318HE
Study Eligibility Criteria
Additional Studies
Additional studies can be found at ClinicalTrials.gov