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A study to document the efficacy, safety and tolerability of long-term administration of RO0503821 in patients with chronic renal anemia. - Article


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Anemia

General anemia 



Clinical Trial: A study to document the efficacy, safety and tolerability of long-term administration of RO0503821 in patients with chronic renal anemia.

This study is currently recruiting patients.

Sponsored by: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche

Purpose

The purpose of this study is to document that RO0503821 administered for prolonged periods (104 weeks) is efficacious, safe, and well tolerated in patients treated for chronic renal anemia.

Condition Treatment or Intervention Phase
Anemia
 Drug: RO0503821
Phase III

MedlinePlus related topics:  Anemia

Study Type: Interventional
Study Design: Treatment

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Written informed consent
  • Adult patients (greater than or equal to 18 years of age) with chronic renal anemia
  • Maintenance erythropoietic therapy with RO0503821 or a protocol-specified reference medication (epoetin alfa formulated with human albumin, epoetin beta or darbepoetin alfa) in one of the following studies: BA16528, BA16285, BA16286, BA16736, BA16738, BA16739, BA16740, BA17283 or BA17284
  • Hemoglobin concentration between 10.5 and 13.0 g/dL
  • Adequate iron status defined as serum ferritin greater than or equal to 100 ng/mL or TSAT greater than or equal to 20% (or percentage of hypochromic RBCs less than 10%)

Exclusion Criteria:

  • Poorly controlled hypertension necessitating interruption of erythropoietic treatment in the 6 months before screening
  • Epileptic seizure in the 6 months before screening
  • Platelets greater than 500 x 10 9/L
  • Pure red cell aplasia (PRCA)
  • Chronic congestive heart failure (New York Heart Association Class IV)
  • High likelihood of early withdrawal or interruption of the study (e.g., myocardial infarction, severe or unstable coronary artery disease, stroke, severe liver disease within the 12 weeks before screening)
  • Active malignant disease (except non-melanoma skin cancer), defined as disease-free for a period of five years
  • Life expectancy less than 12 months
  • Pregnancy or breast-feeding - Women of childbearing potential without effective contraception
  • Administration of another investigational drug planned during the study period
  • Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study or reference drug formulations

Location and Contact Information

Please reference Study ID Number: PDO-BH18387      973-235-5000 
or      800-526-6367 (FOR US ONLY) 

Alabama
      Birmingham,  Alabama,  35211,  United States; Not yet recruiting

      Montgomery,  Alabama,  36106,  United States; Not yet recruiting

      Mobile,  Alabama,  36608,  United States; Not yet recruiting

Arkansas
      Hot Springs,  Arkansas,  71901,  United States; Not yet recruiting

California
      Stanford,  California,  94305-5114,  United States; Not yet recruiting

      Los Angeles,  California,  90073,  United States; Not yet recruiting

      Los Angeles,  California,  90095,  United States; Recruiting

      Mather,  California,  95655,  United States; Not yet recruiting

      Covina,  California,  91723,  United States; Not yet recruiting

      San Diego,  California,  92161,  United States; Not yet recruiting

      San Diego,  California,  92123,  United States; Not yet recruiting

      San Diego,  California,  92103-8342,  United States; Not yet recruiting

      San Diego,  California,  92120,  United States; Not yet recruiting

      Los Alamitos,  California,  90720,  United States; Not yet recruiting

      San Francisco,  California,  94117,  United States; Not yet recruiting

      San Jose,  California,  95116-1906,  United States; Not yet recruiting

      Monterey Park,  California,  91754,  United States; Not yet recruiting

      Tarzana,  California,  91356,  United States; Not yet recruiting

      Sacramento,  California,  95816-5119,  United States; Not yet recruiting

      Riverside,  California,  92501,  United States; Not yet recruiting

      Irvine,  California,  92868,  United States; Not yet recruiting

Colorado
      Colorado Springs,  Colorado,  80909,  United States; Not yet recruiting

      Lakewood,  Colorado,  80260,  United States; Not yet recruiting

      Denver,  Colorado,  80262,  United States; Not yet recruiting

Connecticut
      Stamford,  Connecticut,  06902,  United States; Not yet recruiting

Florida
      Ocala,  Florida,  34471,  United States; Not yet recruiting

      Tampa,  Florida,  33617,  United States; Not yet recruiting

      Pembroke Pines,  Florida,  33028,  United States; Recruiting

Georgia
      Atlanta,  Georgia,  30342,  United States; Not yet recruiting

      Augusta,  Georgia,  30309,  United States; Not yet recruiting

Hawaii
      Honolulu,  Hawaii,  96813,  United States; Not yet recruiting

Illinois
      South Holland,  Illinois,  60473,  United States; Not yet recruiting

      Maywood,  Illinois,  60153,  United States; Recruiting

      Chicago,  Illinois,  60612,  United States; Not yet recruiting

Kentucky
      Louisville,  Kentucky,  40202-1718,  United States; Not yet recruiting

Louisiana
      Shreveport,  Louisiana,  71101,  United States; Not yet recruiting

      Shreveport,  Louisiana,  71103,  United States; Not yet recruiting

      Baton Rouge,  Louisiana,  70884,  United States; Not yet recruiting

Massachusetts
      Boston,  Massachusetts,  02135,  United States; Not yet recruiting

      Boston,  Massachusetts,  02130,  United States; Not yet recruiting

      Boston,  Massachusetts,  02115,  United States; Not yet recruiting

      Springfield,  Massachusetts,  01107,  United States; Not yet recruiting

Michigan
      Detroit,  Michigan,  48236,  United States; Recruiting

      Detroit,  Michigan,  48202,  United States; Recruiting

      Detroit,  Michigan,  48202,  United States; Terminated

      Kalamazoo,  Michigan,  49007,  United States; Not yet recruiting

Minnesota
      Brooklyn Center,  Minnesota,  55430,  United States; Recruiting

Mississippi
      Columbus,  Mississippi,  39705,  United States; Not yet recruiting

      Tupelo,  Mississippi,  38801,  United States; Not yet recruiting

Missouri
      St. Louis,  Missouri,  63110,  United States; Not yet recruiting

Nevada
      Las Vegas,  Nevada,  89106,  United States; Not yet recruiting

New Jersey
      Hackensack,  New Jersey,  07601,  United States; Not yet recruiting

      Paterson,  New Jersey,  07503,  United States; Not yet recruiting

New Mexico
      Albuquerque,  New Mexico,  87131,  United States; Not yet recruiting

New York
      Flushing,  New York,  11355,  United States; Not yet recruiting

      Orchard Park,  New York,  14127,  United States; Not yet recruiting

      New York,  New York,  10128,  United States; Not yet recruiting

      New York,  New York,  10021,  United States; Not yet recruiting

      Bronx,  New York,  10467,  United States; Not yet recruiting

      Mineola,  New York,  11501,  United States; Not yet recruiting

      Brooklyn,  New York,  11203,  United States; Not yet recruiting

      Great Neck,  New York,  11021,  United States; Not yet recruiting

North Carolina
      Winston Salem,  North Carolina,  27157-1023,  United States; Not yet recruiting

      Raleigh,  North Carolina,  27609,  United States; Not yet recruiting

      Chapel Hill,  North Carolina,  27599-7155,  United States; Not yet recruiting

Ohio
      Cincinnati,  Ohio,  45220,  United States; Not yet recruiting

      Cincinnati,  Ohio,  45267-0585,  United States; Not yet recruiting

      Cleveland,  Ohio,  44195,  United States; Not yet recruiting

      Cleveland,  Ohio,  44109,  United States; Not yet recruiting

      Toledo,  Ohio,  43606,  United States; Not yet recruiting

Oregon
      Portland,  Oregon,  97201-2940,  United States; Not yet recruiting

      Portland,  Oregon,  97210,  United States; Not yet recruiting

      Oregon City,  Oregon,  97045,  United States; Not yet recruiting

Pennsylvania
      Allentown,  Pennsylvania,  18103,  United States; Not yet recruiting

      Philadelphia,  Pennsylvania,  19106,  United States; Not yet recruiting

      Philadelphia,  Pennsylvania,  19140,  United States; Not yet recruiting

      Philadelphia,  Pennsylvania,  19141,  United States; Not yet recruiting

      Philadelphia,  Pennsylvania,  19104,  United States; Not yet recruiting

      Lewistown,  Pennsylvania,  17044,  United States; Not yet recruiting

      Erie,  Pennsylvania,  16502,  United States; Not yet recruiting

      Pittsburgh,  Pennsylvania,  15261,  United States; Not yet recruiting

      Pittsburgh,  Pennsylvania,  15224,  United States; Not yet recruiting

South Carolina
      Columbia,  South Carolina,  29209,  United States; Not yet recruiting

      Orangeburg,  South Carolina,  29118,  United States; Not yet recruiting

Tennessee
      Nashville,  Tennessee,  37232-1371,  United States; Recruiting

      Nashville,  Tennessee,  37205,  United States; Not yet recruiting

      Chattanooga,  Tennessee,  37404,  United States; Not yet recruiting

Texas
      Austin,  Texas,  78705,  United States; Not yet recruiting

      Houston,  Texas,  77054,  United States; Not yet recruiting

      Houston,  Texas,  77074,  United States; Not yet recruiting

      Houston,  Texas,  77030,  United States; Not yet recruiting

      Dallas,  Texas,  75216,  United States; Not yet recruiting

      San Antonio,  Texas,  78229,  United States; Not yet recruiting

Vermont
      Burlington,  Vermont,  05401,  United States; Not yet recruiting

Virginia
      Salem,  Virginia,  24153,  United States; Not yet recruiting

      Charlottesville,  Virginia,  22908,  United States; Not yet recruiting

      Norfolk,  Virginia,  23507-1901,  United States; Not yet recruiting

      Fairfax,  Virginia,  22031,  United States; Not yet recruiting

West Virginia
      Morgantown,  West Virginia,  26506,  United States; Not yet recruiting

Wisconsin
      Marshfield,  Wisconsin,  54449,  United States; Not yet recruiting

Australia
      Perth,  6847,  Australia; Not yet recruiting

      Clayton,  3168,  Australia; Not yet recruiting

      Sydney,  1871,  Australia; Not yet recruiting

      Parkville,  3050,  Australia; Not yet recruiting

      Gosford,  2250,  Australia; Not yet recruiting

      Brisbane,  4102,  Australia; Not yet recruiting

      BLACKTOWN,  NSW 2148,  Australia; Not yet recruiting

Austria
      Graz,  8036,  Austria; Not yet recruiting

Belgium
      Leuven,  3000,  Belgium; Not yet recruiting

      BRUXELLES,  1090,  Belgium; Not yet recruiting

      BRUXELLES,  1070,  Belgium; Not yet recruiting

      BRUXELLES,  1200,  Belgium; Not yet recruiting

      Hasselt,  3500,  Belgium; Not yet recruiting

      Gent,  9000,  Belgium; Not yet recruiting

      LIEGE,  4000,  Belgium; Not yet recruiting

      Aalst,  9300,  Belgium; Not yet recruiting

      Edegem,  2650,  Belgium; Not yet recruiting

Canada, Alberta
      Calgary,  Alberta,  T2N 2T9,  Canada; Not yet recruiting

      Edmonton,  Alberta,  T6G 2B7,  Canada; Not yet recruiting

Canada, British Columbia
      Vancouver,  British Columbia,  V6Z 1Y6,  Canada; Not yet recruiting

      New Westminster,  British Columbia,  V3L 3W7,  Canada; Not yet recruiting

      Kamloops,  British Columbia,  V2C 2T1,  Canada; Not yet recruiting

Canada, Manitoba
      Winnipeg,  Manitoba,  R2H 2A6,  Canada; Not yet recruiting

      Winnipeg,  Manitoba,  R3A 1R9,  Canada; Not yet recruiting

Canada, Newfoundland and Labrador
      St. John's,  Newfoundland and Labrador,  A1B 3V6,  Canada; Not yet recruiting

Canada, Nova Scotia
      Halifax,  Nova Scotia,  B3H 1V8,  Canada; Not yet recruiting

Canada, Ontario
      London,  Ontario,  N6A 5A5,  Canada; Not yet recruiting

      Toronto,  Ontario,  M5G 2C4,  Canada; Not yet recruiting

      Toronto,  Ontario,  M4N 3M5,  Canada; Not yet recruiting

      Kitchener,  Ontario,  N2G 1N9,  Canada; Not yet recruiting

      Scarborough,  Ontario,  M1H 3G4,  Canada; Not yet recruiting

      Ottawa,  Ontario,  K1H 7W9,  Canada; Not yet recruiting

      Mississauga,  Ontario,  L5M 2V8,  Canada; Not yet recruiting

      Kingston,  Ontario,  K7L 3N6,  Canada; Not yet recruiting

      Weston,  Ontario,  M9N 1N8,  Canada; Not yet recruiting

Canada, Quebec
      Montreal,  Quebec,  H1T 2M4,  Canada; Not yet recruiting

      Montreal,  Quebec,  H3A 1A1,  Canada; Not yet recruiting

      Montreal,  Quebec,  H3G 1A4,  Canada; Not yet recruiting

      Greenfield Park,  Quebec,  J4V 2H1,  Canada; Not yet recruiting

Canada, Saskatchewan
      Saskatoon,  Saskatchewan,  S7K 1N4,  Canada; Not yet recruiting

Czech Republic
      LIBEREC,  460 63,  Czech Republic; Not yet recruiting

      Praha,  169 00,  Czech Republic; Not yet recruiting

      PILSEN,  304 60,  Czech Republic; Not yet recruiting

      Brno,  65691,  Czech Republic; Not yet recruiting

      OSTRAVA PORUBA,  708 52,  Czech Republic; Not yet recruiting

Denmark
      Roskilde,  4000,  Denmark; Not yet recruiting

      Aalborg,  9100,  Denmark; Not yet recruiting

      Odense,  5000,  Denmark; Not yet recruiting

Finland
      Tampere,  33521,  Finland; Not yet recruiting

      Turku,  20521,  Finland; Not yet recruiting

      HUS,  00029,  Finland; Not yet recruiting

France
      Vandoeuvre-les-Nancy,  54511,  France; Not yet recruiting

      Perpignan,  66046,  France; Not yet recruiting

      Nantes,  44035,  France; Not yet recruiting

      Nantes,  44093,  France; Not yet recruiting

      Toulouse,  31059,  France; Not yet recruiting

      Paris,  75908,  France; Not yet recruiting

      Lyon,  69437,  France; Not yet recruiting

      Amiens,  80054,  France; Not yet recruiting

      Colmar,  68024,  France; Not yet recruiting

      Chambery,  73001,  France; Not yet recruiting

      Rouen,  76031,  France; Not yet recruiting

      Hyeres,  83400,  France; Not yet recruiting

      Strasbourg,  67091,  France; Not yet recruiting

      Aubervilliers,  93307,  France; Not yet recruiting

      Nice,  06002,  France; Not yet recruiting

      Tarbes,  65013,  France; Not yet recruiting

      Montpellier,  34295,  France; Not yet recruiting

      Poitiers,  86021,  France; Not yet recruiting

      Cabestany,  66330,  France; Not yet recruiting

      Saint-Etienne,  12055,  France; Not yet recruiting

      Limoges,  87042,  France; Not yet recruiting

      Saint-Germain-en-Laye,  78100,  France; Not yet recruiting

      Nimes,  30029,  France; Not yet recruiting

      Caen,  14033,  France; Not yet recruiting

      Boulogne-sur-Mer,  62321,  France; Not yet recruiting

      Tours,  37044,  France; Not yet recruiting

      Bayonne,  64115,  France; Not yet recruiting

      Thionville,  57126,  France; Not yet recruiting

      Bordeaux,  33076,  France; Not yet recruiting

      Grenoble,  38043,  France; Not yet recruiting

Germany
      Duesseldorf,  40225,  Germany; Not yet recruiting

      Dortmund,  44263,  Germany; Not yet recruiting

      Bonn,  53105,  Germany; Not yet recruiting

      Aschaffenburg,  63741,  Germany; Not yet recruiting

      Tuebingen,  72076,  Germany; Not yet recruiting

      Berlin,  13353,  Germany; Not yet recruiting

      Berlin,  12045,  Germany; Not yet recruiting

      Muenchen,  80804,  Germany; Not yet recruiting

      Nuernberg,  90431,  Germany; Not yet recruiting

      Erlangen,  91054,  Germany; Not yet recruiting

      Villingen-Schwenningen,  78054,  Germany; Not yet recruiting

      Wiesbaden,  65191,  Germany; Not yet recruiting

      Stuttgart,  70191,  Germany; Not yet recruiting

      WIESLOCH,  69168,  Germany; Not yet recruiting

      BAD HERSFELD,  36251,  Germany; Not yet recruiting

      Wuppertal,  42103,  Germany; Not yet recruiting

      HANN. MUENDEN,  34346,  Germany; Not yet recruiting

Greece
      IOANNIAN,  45500,  Greece; Not yet recruiting

      THESSALONIKI,  54629,  Greece; Not yet recruiting

      ALEXANDROUPOLIS,  68100,  Greece; Not yet recruiting

      PIREAS,  18536,  Greece; Not yet recruiting

      LARISSA,  41001,  Greece; Not yet recruiting

Hungary
      Pecs,  H-7624,  Hungary; Not yet recruiting

      Debrecen,  4032,  Hungary; Not yet recruiting

      Budapest,  1076,  Hungary; Not yet recruiting

      Budapest,  1134,  Hungary; Not yet recruiting

      Miskolc,  3526,  Hungary; Not yet recruiting

Italy
      Cuneo,  12100,  Italy; Not yet recruiting

      Lecco,  23900,  Italy; Not yet recruiting

      Pavia,  27100,  Italy; Recruiting

      Modena,  41100,  Italy; Recruiting

      Cagliari,  09100,  Italy; Not yet recruiting

      Prato,  50047,  Italy; Not yet recruiting

      Lodi,  26900,  Italy; Not yet recruiting

      Roma,  00184,  Italy; Not yet recruiting

      Genova,  16132,  Italy; Not yet recruiting

      Reggio Calabria,  89100,  Italy; Not yet recruiting

      Como,  22100,  Italy; Not yet recruiting

      Cremona,  26100,  Italy; Not yet recruiting

      Venezia,  30122,  Italy; Not yet recruiting

      VENEZIA MESTRE,  30174,  Italy; Not yet recruiting

      Bergamo,  24128,  Italy; Not yet recruiting

      Messina,  98158,  Italy; Not yet recruiting

      Livorno,  57100,  Italy; Not yet recruiting

Mexico
      Cuernavaca,  62448,  Mexico; Not yet recruiting

      Mexico City,  14000,  Mexico; Not yet recruiting

Netherlands
      HEERLEN,  6401,  Netherlands; Not yet recruiting

      Amersfoort,  3818,  Netherlands; Not yet recruiting

Norway
      BERGEN,  5021,  Norway; Not yet recruiting

      LILLEHAMMER,  2629,  Norway; Not yet recruiting

      Trondheim,  7006,  Norway; Not yet recruiting

Panama
      Panama City,  32405,  Panama; Not yet recruiting

Poland
      Poznan,  60-355,  Poland; Not yet recruiting

      GDYNIA,  81-519,  Poland; Not yet recruiting

      Wroclaw,  50-417,  Poland; Not yet recruiting

      Krakow,  31-501,  Poland; Not yet recruiting

      Lodz,  90153,  Poland; Not yet recruiting

      Szczecin,  70-111,  Poland; Not yet recruiting

      Kielce,  25-736,  Poland; Not yet recruiting

      Gdansk,  80-211,  Poland; Not yet recruiting

      WOLOMIN,  05-200,  Poland; Not yet recruiting

Portugal
      SETUBAL,  2910-446,  Portugal; Not yet recruiting

      Porto,  4099-001,  Portugal; Not yet recruiting

Puerto Rico
      San Juan,  00936-5067,  Puerto Rico; Not yet recruiting

      Ponce,  00732,  Puerto Rico; Not yet recruiting

Russian Federation
      Moscow,  123182,  Russian Federation; Not yet recruiting

      Moscow,  125101,  Russian Federation; Not yet recruiting

      Moscow,  129110,  Russian Federation; Not yet recruiting

      St Petersburg,  195067,  Russian Federation; Not yet recruiting

      St Petersburg,  197089,  Russian Federation; Not yet recruiting

South Africa
      Durban,  South Africa; Not yet recruiting

      Soweto,  South Africa; Not yet recruiting

      Johannesburg,  2193,  South Africa; Not yet recruiting

      CAPETOWN,  7925,  South Africa; Not yet recruiting

Spain
      Madrid,  28046,  Spain; Not yet recruiting

      Madrid,  28805,  Spain; Not yet recruiting

      Madrid,  28041,  Spain; Not yet recruiting

      Madrid,  28007,  Spain; Not yet recruiting

      Madrid,  28006,  Spain; Not yet recruiting

      Madrid,  28035,  Spain; Not yet recruiting

      Lerida,  25198,  Spain; Not yet recruiting

      Almeria,  04009,  Spain; Not yet recruiting

      Barcelona,  08907,  Spain; Not yet recruiting

      Barcelona,  08036,  Spain; Not yet recruiting

      Barcelona,  08003,  Spain; Not yet recruiting

      Barcelona,  08035,  Spain; Not yet recruiting

      Palma de Mallorca,  07014,  Spain; Not yet recruiting

      Palma de Mallorca,  07198,  Spain; Not yet recruiting

      Alicante,  03010,  Spain; Not yet recruiting

      Badalona,  08915,  Spain; Not yet recruiting

      Santander,  39008,  Spain; Not yet recruiting

      Salamanca,  37008,  Spain; Not yet recruiting

      Bilbao,  48013,  Spain; Not yet recruiting

      La Coruna,  15006,  Spain; Not yet recruiting

      Oviedo,  33006,  Spain; Not yet recruiting

      Malaga,  29010,  Spain; Not yet recruiting

      Cordoba,  14004,  Spain; Not yet recruiting

      Sevilla,  41013,  Spain; Not yet recruiting

      ALCORCON (MADRID),  28922,  Spain; Not yet recruiting

      Santiago de Compostela,  15706,  Spain; Not yet recruiting

Switzerland
      Lausanne,  1003,  Switzerland; Not yet recruiting

      Lausanne,  1011,  Switzerland; Not yet recruiting

      AARAU,  5001,  Switzerland; Not yet recruiting

Taiwan, Province of China
      Taipei,  Taiwan, Province of China; Not yet recruiting

      Taichung,  Taiwan, Province of China; Not yet recruiting

      Kaohsiung,  833,  Taiwan, Province of China; Not yet recruiting

Thailand
      Bangkok,  Thailand; Not yet recruiting

      Bangkok,  10400,  Thailand; Not yet recruiting

      Bangkok,  10700,  Thailand; Not yet recruiting

      Bangkok,  10330,  Thailand; Not yet recruiting

      CHONBURI,  Thailand; Not yet recruiting

      PHITSANULOK,  65000,  Thailand; Not yet recruiting

      Chiang Mai,  50200,  Thailand; Not yet recruiting

United Kingdom
      Nottingham,  NG2 3HF,  United Kingdom; Completed

      London,  SE1 9 RT,  United Kingdom; Not yet recruiting

      London,  SE22 8PT,  United Kingdom; Not yet recruiting

      London,  SW17 ORE,  United Kingdom; Not yet recruiting

      London,  E1 1BB,  United Kingdom; Not yet recruiting

      Leicester,  LE5 4PW,  United Kingdom; Not yet recruiting

      CARSHALTON, SURREY,  SM5 1AA,  United Kingdom; Not yet recruiting

      Swansea,  SA6 6NL,  United Kingdom; Not yet recruiting

      Salford,  M6 8HD,  United Kingdom; Not yet recruiting

      HERTFORDSHIRE,  SG1 4AB,  United Kingdom; Not yet recruiting

      Glasgow,  G4 0SF,  United Kingdom; Not yet recruiting

      Belfast,  BT9 7LJ,  United Kingdom; Not yet recruiting

      Exeter,  EX2 5DW,  United Kingdom; Not yet recruiting

      Cambridge,  CB2 2QQ,  United Kingdom; Not yet recruiting

      Dundee,  DD1 9SY,  United Kingdom; Not yet recruiting

      Peterborough,  PE4 6NA,  United Kingdom; Completed

More Information

Study ID Numbers:  BH18387
Record last reviewed:  March 2005
Last Updated:  March 25, 2005
Record first received:  September 3, 2004
ClinicalTrials.gov Identifier:  NCT00090753
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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October 24, 2014



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