Study Of Diabetic Nephropathy With Atrasentan (SONAR)

This study is currently recruiting participants.
Verified January 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01858532
First received: May 17, 2013
Last updated: January 5, 2014
Last verified: January 2014
  Purpose

This study is being conducted to evaluate the effects of Atrasentan on Renal Outcomes in Subjects with Type 2 Diabetes and Nephropathy.


Condition Intervention Phase
Diabetic Nephropathy
Drug: Atrasentan
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicountry, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in Subjects With Type 2 Diabetes and Nephropathy SONAR: Study Of Diabetic Nephropathy With Atrasentan

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Time to the first occurrence of a component of the composite renal endpoint. [ Time Frame: Approximately 48 months. ] [ Designated as safety issue: Yes ]
    Time to the first occurrence of a component of the composite renal endpoint: doubling of serum creatinine (confirmed by a 30-day serum creatinine) or the onset of end stage renal disease (needing chronic dialysis or renal transplantation or renal death).


Secondary Outcome Measures:
  • Change from baseline to Month 24 post-randomization visit on urine albumin creatinine ratio. [ Time Frame: From Day 0 to 24 months. ] [ Designated as safety issue: Yes ]
  • Time to a 30% estimated glomerular filtration rate reduction after 3 months post-randomization treatment. [ Time Frame: Approximately 24 months. ] [ Designated as safety issue: Yes ]
  • Time to cardio-renal composite endpoint: doubling of serum creatinine, end stage renal disease, cardiovascular death, nonfatal myocardial infarction, nonfatal stroke. [ Time Frame: Approximately 48 months. ] [ Designated as safety issue: Yes ]
  • Time to the cardiovascular composite endpoint: cardiovascular death, nonfatal myocardial infarction and nonfatal stroke. [ Time Frame: Approximately 48 months. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 4148
Study Start Date: May 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Atrasentan
Subjects randomized to the atrasentan arm will receive active drug, atrasentan.
Drug: Atrasentan
Oral daily low dose for 48 months.
Placebo Comparator: Placebo
Subjects randomized to the placebo arm will receive placebo.
Drug: Placebo
Oral daily dosing for 48 months.

Detailed Description:

The study objective is to evaluate the effect of atrasentan compared with placebo on time to doubling of serum creatinine or the onset of end stage renal disease (ESRD) in subjects with type 2 diabetes and nephropathy who are treated with the maximum tolerated labeled daily dose (MTLDD) of a Renin Angiotensin System (RAS) inhibitor. In addition, the study will assess the effects of atrasentan compared with placebo on cardiovascular morbidity and mortality, urine albumin excretion, changes in estimated glomerular filtration rate (eGFR), as well as on the impact on quality of life in subjects with type 2 diabetes and nephropathy.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has type 2 diabetes and has been treated with at least one anti-hyperglycemic medication and angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blockers (ARB) (Renin Angiotensin System inhibitor) for at least 3 months prior to the Screening Period.
  • Glucosylated hemoglobin A1c (HbA1c) less than or equal to 12%.
  • For entry into the Run-In Period the subject must satisfy the following criteria based on the Screening laboratory values:

    • Estimated glomerular filtration rate (eGFR) 25 to 75 mL/min/1.73 m2 and a urine albumin creatinine ratio (UACR) greater than or equal to 300 and less than 5,000 mg/g (The number of subjects with eGFR between 60 to 75 mL/min/1.73 m2 will be capped to 10% of the total population);
    • Serum albumin greater than or equal to 3.0 g/dL (30 g/L);
    • Brain natriuretic peptide (BNP) less than or equal to 200 pg/mL (200 ng/L);
    • Systolic blood pressure (SBP) greater than or equal to 110 and less than or equal to 160 mmHg;
    • Serum Potassium greater than or equal to 3.5 (3.5 mmol/L) and less than or equal to 5.5 mEq/L (5.5 mmol/L);
    • Subjects on a maximum tolerated labeled daily dose (MTLDD) of a RAS inhibitor for greater than or equal to 4 weeks and on a diuretic at the time of screening and who satisfy the above criteria may proceed to the last visit in Run-In Period (R6);
    • Subjects already on a MTLDD of a RAS inhibitor for greater than or equal to 4 weeks and not on a diuretic (unless medically contraindicated) at the time of Screening will start with a diuretic and proceed to Run-In for at least 2 weeks.
  • For entry into the Enrichment Period the subject must satisfy the following criteria based on the last visit of the Run-In Period:

    • RAS inhibitor at the MTLDD for the previous 4 weeks with no adjustments of the dose;
    • Subjects that were on a MTLDD RAS inhibitor and not on a diuretic (unless medically contraindicated) at the time of Screening must have been in Run-In for at least 2 weeks.
  • For entry into the Double-Blind Treatment Period, the subject must satisfy the following criteria based on the last visit of the Enrichment Period:

    • RAS inhibitor at the MTLDD for the previous 6 weeks during the Enrichment Period with no adjustments of the dose;
    • Diuretic at any dose unless medically contraindicated or clinically intolerable in the investigator's judgement (i.e., hypotension or hypokalemia);
    • Weight change less than 3 kg and absolute serum BNP less than 300 pg/mL (300 ng/L) at Enrichment Week 6 from the beginning of Enrichment;
    • Subjects must not have an acute kidney injury (AKI) event at the end of the Enrichment period, as defined by an increase from baseline in serum Creatinine greater than 0.5 mg/dL and greater than 20% increase at Enrichment Week 6 (visit E5) from baseline.

Exclusion Criteria:

  • Subject has a history of moderate or severe peripheral edema, pulmonary edema or facial edema unrelated to trauma or a history of myxedema in the prior 6 months to Screening.
  • Subject has a history of pulmonary hypertension requiring oxygen therapy, and/or endothelin receptor antagonist or phosphodiesterase therapy or any lung diseases requiring oxygen therapy (e.g., chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis).
  • Subject has a documented diagnosis of heart failure, previous hospitalization for heart failure or current or constellation of symptoms (dyspnea on exertion, pedal edema, orthopnea, paroxysmal nocturnal dyspnea) felt to be compatible with heart failure, that was not explained by other causes, and for which there was a change in medication or other management directed at heart failure.
  • Subject has known non-diabetic kidney disease (other than kidney stones).
  • Subject has a history of symptomatic hypotension within the last 6 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01858532

Contacts
Contact: Blai Coll, MD 847-937-6156 blai.coll@abbvie.com
Contact: Renee Heuser, BS 847-938-5887 renee.heuser@abbvie.com

  Hide Study Locations
Locations
United States, Alabama
Site Reference ID/Investigator# 105317 Recruiting
Birmingham, Alabama, United States, 35211
Principal Investigator: Site Reference ID/Investigator# 105317         
United States, Arizona
Site Reference ID/Investigator# 106300 Recruiting
Peoria, Arizona, United States, 85381
Principal Investigator: Site Reference ID/Investigator# 106300         
Site Reference ID/Investigator# 107196 Recruiting
Phoneix, Arizona, United States, 85032
Principal Investigator: Site Reference ID/Investigator# 107196         
Site Reference ID/Investigator# 118549 Recruiting
Prescott, Arizona, United States, 86301
Principal Investigator: Site Reference ID/Investigator# 118549         
Site Reference ID/Investigator# 110376 Recruiting
Tucson, Arizona, United States, 85712
Principal Investigator: Site Reference ID/Investigator# 110376         
United States, Arkansas
Site Reference ID/Investigator# 107678 Recruiting
Little Rock, Arkansas, United States, 72223
Principal Investigator: Site Reference ID/Investigator# 107678         
United States, California
Site Reference ID/Investigator# 99948 Recruiting
Alhambra, California, United States, 91801
Principal Investigator: Site Reference ID/Investigator# 99948         
Site Reference ID/Investigator# 96605 Recruiting
Azusa, California, United States, 91702
Principal Investigator: Site Reference ID/Investigator# 96605         
Site Reference ID/Investigator# 101579 Recruiting
Azusa, California, United States, 91702
Principal Investigator: Site Reference ID/Investigator# 101579         
Site Reference ID/Investigator# 114816 Recruiting
Bakersfield, California, United States, 93309
Principal Investigator: Site Reference ID/Investigator# 114816         
Site Reference ID/Investigator# 96591 Recruiting
Chula Vista, California, United States, 91910
Principal Investigator: Site Reference ID/Investigator# 96591         
Site Reference ID/Investigator# 99975 Recruiting
Chula Vista, California, United States, 91911
Principal Investigator: Site Reference ID/Investigator# 99975         
Site Reference ID/Investigator# 105498 Recruiting
Corona, California, United States, 92880
Principal Investigator: Site Reference ID/Investigator# 105498         
Site Reference ID/Investigator# 105566 Recruiting
Downey, California, United States, 90241
Principal Investigator: Site Reference ID/Investigator# 105566         
Site Reference ID/Investigator# 101476 Recruiting
Fullerton, California, United States, 92835
Principal Investigator: Site Reference ID/Investigator# 101476         
Site Reference ID/Investigator# 96597 Recruiting
La Mesa, California, United States, 91942
Principal Investigator: Site Reference ID/Investigator# 96597         
Site Reference ID/Investigator# 99397 Recruiting
Los Angeles, California, United States, 90036
Principal Investigator: Site Reference ID/Investigator# 99397         
Site Reference ID/Investigator# 104915 Recruiting
Los Angeles, California, United States, 90059
Principal Investigator: Site Reference ID/Investigator# 104915         
Site Reference ID/Investigator# 96596 Recruiting
Los Angeles, California, United States, 90022
Principal Investigator: Site Reference ID/Investigator# 96596         
Site Reference ID/Investigator# 96704 Recruiting
Mission Hills, California, United States, 91345
Principal Investigator: Site Reference ID/Investigator# 96704         
Site Reference ID/Investigator# 102095 Recruiting
North Hollywood, California, United States, 91606
Principal Investigator: Site Reference ID/Investigator# 102095         
Site Reference ID/Investigator# 105199 Recruiting
Norwalk, California, United States, 90650
Principal Investigator: Site Reference ID/Investigator# 105199         
Site Reference ID/Investigator# 107200 Recruiting
Orange, California, United States, 92868
Principal Investigator: Site Reference ID/Investigator# 107200         
Site Reference ID/Investigator# 96702 Recruiting
Palm Springs, California, United States, 92262
Principal Investigator: Site Reference ID/Investigator# 96702         
Site Reference ID/Investigator# 110415 Recruiting
Paramount, California, United States, 90723
Principal Investigator: Site Reference ID/Investigator# 110415         
Site Reference ID/Investigator# 105576 Recruiting
Porterville, California, United States, 93257
Principal Investigator: Site Reference ID/Investigator# 105576         
Site Reference ID/Investigator# 107455 Recruiting
Riverside, California, United States, 92505
Principal Investigator: Site Reference ID/Investigator# 107455         
Site Reference ID/Investigator# 104900 Recruiting
Sacramento, California, United States, 95825
Principal Investigator: Site Reference ID/Investigator# 104900         
Site Reference ID/Investigator# 105316 Recruiting
San Diego, California, United States, 92123
Principal Investigator: Site Reference ID/Investigator# 105316         
Site Reference ID/Investigator# 96640 Recruiting
Santa Barbara, California, United States, 93110
Principal Investigator: Site Reference ID/Investigator# 96640         
United States, Connecticut
Site Reference ID/Investigator# 111219 Not yet recruiting
New Haven, Connecticut, United States, 06510
Principal Investigator: Site Reference ID/Investigator# 111219         
Site Reference ID/Investigator# 104911 Recruiting
Stamford, Connecticut, United States, 06902
Principal Investigator: Site Reference ID/Investigator# 104911         
United States, Delaware
Site Reference ID/Investigator# 106297 Recruiting
Newark, Delaware, United States, 19713
Principal Investigator: Site Reference ID/Investigator# 106297         
United States, District of Columbia
Site Reference ID/Investigator# 96707 Recruiting
Washington, District of Columbia, United States, 20037
Principal Investigator: Site Reference ID/Investigator# 96707         
United States, Florida
Site Reference ID/Investigator# 117452 Recruiting
Aventura, Florida, United States, 33180
Principal Investigator: Site Reference ID/Investigator# 117452         
Site Reference ID/Investigator# 105438 Recruiting
Coral Springs, Florida, United States, 33071
Principal Investigator: Site Reference ID/Investigator# 105438         
Site Reference ID/Investigator# 105315 Recruiting
Fort Myers, Florida, United States, 33912
Principal Investigator: Site Reference ID/Investigator# 105315         
Site Reference ID/Investigator# 116195 Recruiting
Hialeah, Florida, United States, 33012
Principal Investigator: Site Reference ID/Investigator# 116195         
Site Reference ID/Investigator# 99897 Recruiting
Kissimmee, Florida, United States, 34741
Principal Investigator: Site Reference ID/Investigator# 99897         
Site Reference ID/Investigator# 118315 Recruiting
Miami, Florida, United States, 33122
Principal Investigator: Site Reference ID/Investigator# 118315         
Site Reference ID/Investigator# 111220 Recruiting
Miami, Florida, United States, 33015
Principal Investigator: Site Reference ID/Investigator# 111220         
Site Reference ID/Investigator# 111221 Recruiting
Orlando, Florida, United States, 32806
Principal Investigator: Site Reference ID/Investigator# 111221         
Site Reference ID/Investigator# 96623 Recruiting
Pembroke Pines, Florida, United States, 33028
Principal Investigator: Site Reference ID/Investigator# 96623         
Site Reference ID/Investigator# 111223 Recruiting
Pembroke Pines, Florida, United States, 33026
Principal Investigator: Site Reference ID/Investigator# 111223         
Site Reference ID/Investigator# 105436 Recruiting
Port Charlotte, Florida, United States, 33983
Principal Investigator: Site Reference ID/Investigator# 105436         
Site Reference ID/Investigator# 105196 Recruiting
St. Cloud, Florida, United States, 34741
Principal Investigator: Site Reference ID/Investigator# 105196         
Site Reference ID/Investigator# 118760 Recruiting
St. Petersburg, Florida, United States, 33713
Principal Investigator: Site Reference ID/Investigator# 118760         
Site Reference ID/Investigator# 106296 Recruiting
Tampa, Florida, United States, 33606
Principal Investigator: Site Reference ID/Investigator# 106296         
Site Reference ID/Investigator# 96606 Recruiting
West Palm Beach, Florida, United States, 33401
Principal Investigator: Site Reference ID/Investigator# 96606         
United States, Georgia
Site Reference ID/Investigator# 107999 Recruiting
Decatur, Georgia, United States, 30030
Principal Investigator: Site Reference ID/Investigator# 107999         
Site Reference ID/Investigator# 105177 Recruiting
Dunwoody, Georgia, United States, 30338
Principal Investigator: Site Reference ID/Investigator# 105177         
Site Reference ID/Investigator# 99945 Recruiting
Lawrenceville, Georgia, United States, 30046
Principal Investigator: Site Reference ID/Investigator# 99945         
Site Reference ID/Investigator# 105155 Recruiting
Suwanee, Georgia, United States, 30024
Principal Investigator: Site Reference ID/Investigator# 105155         
United States, Hawaii
Site Reference ID/Investigator# 96598 Recruiting
Honolulu, Hawaii, United States, 96814
Principal Investigator: Site Reference ID/Investigator# 96598         
Site Reference ID/Investigator# 99596 Recruiting
Honolulu, Hawaii, United States, 96813
Principal Investigator: Site Reference ID/Investigator# 99596         
United States, Illinois
Site Reference ID/Investigator# 96588 Recruiting
Chicago, Illinois, United States, 60616
Principal Investigator: Site Reference ID/Investigator# 96588         
Site Reference ID/Investigator# 101577 Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Site Reference ID/Investigator# 101577         
Site Reference ID/Investigator# 117095 Recruiting
Evanston, Illinois, United States, 60201
Principal Investigator: Site Reference ID/Investigator# 117095         
Site Reference ID/Investigator# 114936 Recruiting
Joliet, Illinois, United States, 60435
Principal Investigator: Site Reference ID/Investigator# 114936         
United States, Indiana
Site Reference ID/Investigator# 111215 Recruiting
Anderson, Indiana, United States, 46011
Principal Investigator: Site Reference ID/Investigator# 111215         
United States, Iowa
Site Reference ID/Investigator# 105297 Recruiting
Des Moines, Iowa, United States, 50314
Principal Investigator: Site Reference ID/Investigator# 105297         
Site Reference ID/Investigator# 107677 Not yet recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Site Reference ID/Investigator# 107677         
United States, Kentucky
Site Reference ID/Investigator# 110456 Recruiting
Paducah, Kentucky, United States, 42003
Principal Investigator: Site Reference ID/Investigator# 110456         
United States, Louisiana
Site Reference ID/Investigator# 112921 Recruiting
Metairie, Louisiana, United States, 70006
Principal Investigator: Site Reference ID/Investigator# 112921         
Site Reference ID/Investigator# 104135 Not yet recruiting
New Orleans, Louisiana, United States, 70112
Principal Investigator: Site Reference ID/Investigator# 104135         
Site Reference ID/Investigator# 110457 Recruiting
New Orleans, Louisiana, United States, 70115
Principal Investigator: Site Reference ID/Investigator# 110457         
Site Reference ID/Investigator# 100456 Recruiting
Ruston, Louisiana, United States, 71270
Principal Investigator: Site Reference ID/Investigator# 100456         
United States, Maine
Site Reference ID/Investigator# 110377 Recruiting
Auburn, Maine, United States, 04210
Principal Investigator: Site Reference ID/Investigator# 110377         
Site Reference ID/Investigator# 110455 Recruiting
Portland, Maine, United States, 04102
Principal Investigator: Site Reference ID/Investigator# 110455         
United States, Maryland
Site Reference ID/Investigator# 105536 Recruiting
Annapolis, Maryland, United States, 21401
Principal Investigator: Site Reference ID/Investigator# 105536         
Site Reference ID/Investigator# 96610 Recruiting
Baltimore, Maryland, United States, 21204
Principal Investigator: Site Reference ID/Investigator# 96610         
Site Reference ID/Investigator# 96590 Recruiting
Rockville, Maryland, United States, 20852
Principal Investigator: Site Reference ID/Investigator# 96590         
United States, Massachusetts
Site Reference ID/Investigator# 112919 Not yet recruiting
Haverhill, Massachusetts, United States, 01830
Principal Investigator: Site Reference ID/Investigator# 112919         
Site Reference ID/Investigator# 96637 Recruiting
Holyoke, Massachusetts, United States, 01040
Principal Investigator: Site Reference ID/Investigator# 96637         
Site Reference ID/Investigator# 99946 Recruiting
Plymouth, Massachusetts, United States, 02360
Principal Investigator: Site Reference ID/Investigator# 99946         
United States, Michigan
Site Reference ID/Investigator# 105417 Recruiting
East Lansing, Michigan, United States, 48824
Principal Investigator: Site Reference ID/Investigator# 105417         
Site Reference ID/Investigator# 105176 Recruiting
Flint, Michigan, United States, 48504
Principal Investigator: Site Reference ID/Investigator# 105176         
Site Reference ID/Investigator# 96613 Recruiting
Flint, Michigan, United States, 48503
Principal Investigator: Site Reference ID/Investigator# 96613         
Site Reference ID/Investigator# 105198 Recruiting
Rochester, Michigan, United States, 48307
Principal Investigator: Site Reference ID/Investigator# 105198         
United States, Missouri
Site Reference ID/Investigator# 96589 Recruiting
Farmington, Missouri, United States, 63640
Principal Investigator: Site Reference ID/Investigator# 96589         
United States, Nebraska
Site Reference ID/Investigator# 96616 Recruiting
Omaha, Nebraska, United States, 68131
Principal Investigator: Site Reference ID/Investigator# 96616         
United States, Nevada
Site Reference ID/Investigator# 112900 Recruiting
Las Vegas, Nevada, United States, 89115
Principal Investigator: Site Reference ID/Investigator# 112900         
Site Reference ID/Investigator# 105501 Recruiting
Las Vegas, Nevada, United States, 89148
Principal Investigator: Site Reference ID/Investigator# 105501         
Site Reference ID/Investigator# 104910 Recruiting
Reno, Nevada, United States, 89511
Principal Investigator: Site Reference ID/Investigator# 104910         
United States, New Hampshire
Site Reference ID/Investigator# 105444 Recruiting
Portsmouth, New Hampshire, United States, 03801
Principal Investigator: Site Reference ID/Investigator# 105444         
United States, New Jersey
Site Reference ID/Investigator# 105075 Recruiting
Camden, New Jersey, United States, 08103
Principal Investigator: Site Reference ID/Investigator# 105075         
Site Reference ID/Investigator# 103995 Recruiting
Eatontown, New Jersey, United States, 07724
Principal Investigator: Site Reference ID/Investigator# 103995         
Site Reference ID/Investigator# 104905 Recruiting
Neptune, New Jersey, United States, 07753
Principal Investigator: Site Reference ID/Investigator# 104905         
United States, New Mexico
Site Reference ID/Investigator# 106276 Recruiting
Albuquerque, New Mexico, United States, 87109
Principal Investigator: Site Reference ID/Investigator# 106276         
Site Reference ID/Investigator# 107675 Recruiting
Albuquerque, New Mexico, United States, 87109
Principal Investigator: Site Reference ID/Investigator# 107675         
United States, New York
Site Reference ID/Investigator# 96592 Recruiting
Albany, New York, United States, 12206
Principal Investigator: Site Reference ID/Investigator# 96592         
Site Reference ID/Investigator# 110375 Recruiting
Bronx, New York, United States, 10467
Principal Investigator: Site Reference ID/Investigator# 110375         
Site Reference ID/Investigator# 116196 Recruiting
Brooklyn, New York, United States, 11229
Principal Investigator: Site Reference ID/Investigator# 116196         
Site Reference ID/Investigator# 111216 Recruiting
Brooklyn, New York, United States, 11224
Principal Investigator: Site Reference ID/Investigator# 111216         
Site Reference ID/Investigator# 112903 Not yet recruiting
Brooklyn, New York, United States, 11203
Principal Investigator: Site Reference ID/Investigator# 112903         
Site Reference ID/Investigator# 96604 Recruiting
New Hyde Park, New York, United States, 11042
Principal Investigator: Site Reference ID/Investigator# 96604         
Site Reference ID/Investigator# 107215 Recruiting
New York, New York, United States, 10001
Principal Investigator: Site Reference ID/Investigator# 107215         
Site Reference ID/Investigator# 105235 Recruiting
New York, New York, United States, 10021
Principal Investigator: Site Reference ID/Investigator# 105235         
Site Reference ID/Investigator# 106835 Recruiting
New York, New York, United States, 10021
Principal Investigator: Site Reference ID/Investigator# 106835         
Site Reference ID/Investigator# 112896 Recruiting
New York, New York, United States, 10018
Principal Investigator: Site Reference ID/Investigator# 112896         
Site Reference ID/Investigator# 96603 Recruiting
Orchard Park, New York, United States, 14220
Principal Investigator: Site Reference ID/Investigator# 96603         
Site Reference ID/Investigator# 104137 Recruiting
Rosedale, New York, United States, 11422
Principal Investigator: Site Reference ID/Investigator# 104137         
United States, North Carolina
Site Reference ID/Investigator# 112918 Recruiting
Charlotte, North Carolina, United States, 28277
Principal Investigator: Site Reference ID/Investigator# 112918         
Site Reference ID/Investigator# 96638 Recruiting
Charlotte, North Carolina, United States, 28207
Principal Investigator: Site Reference ID/Investigator# 96638         
Site Reference ID/Investigator# 99898 Recruiting
Morehead, North Carolina, United States, 28557
Principal Investigator: Site Reference ID/Investigator# 99898         
Site Reference ID/Investigator# 100876 Recruiting
New Bern, North Carolina, United States, 28562
Principal Investigator: Site Reference ID/Investigator# 100876         
Site Reference ID/Investigator# 104903 Recruiting
Rocky Mount, North Carolina, United States, 27804
Principal Investigator: Site Reference ID/Investigator# 104903         
Site Reference ID/Investigator# 96700 Recruiting
Wilmington, North Carolina, United States, 28401
Principal Investigator: Site Reference ID/Investigator# 96700         
Site Reference ID/Investigator# 96602 Recruiting
Winston-Salem, North Carolina, United States, 27103
Principal Investigator: Site Reference ID/Investigator# 96602         
United States, Ohio
Site Reference ID/Investigator# 96708 Recruiting
Cleveland, Ohio, United States, 44109-1998
Principal Investigator: Site Reference ID/Investigator# 96708         
Site Reference ID/Investigator# 111224 Not yet recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Site Reference ID/Investigator# 111224         
Site Reference ID/Investigator# 103997 Recruiting
Columbus, Ohio, United States, 43201
Principal Investigator: Site Reference ID/Investigator# 103997         
United States, Oregon
Site Reference ID/Investigator# 105458 Not yet recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Site Reference ID/Investigator# 105458         
United States, Pennsylvania
Site Reference ID/Investigator# 96607 Recruiting
Bethlehem, Pennsylvania, United States, 18017
Principal Investigator: Site Reference ID/Investigator# 96607         
Site Reference ID/Investigator# 107198 Recruiting
Hershey, Pennsylvania, United States, 17033
Principal Investigator: Site Reference ID/Investigator# 107198         
Site Reference ID/Investigator# 111226 Recruiting
Phialdelphia, Pennsylvania, United States, 19146
Principal Investigator: Site Reference ID/Investigator# 111226         
Site Reference ID/Investigator# 107195 Recruiting
Philadelphia, Pennsylvania, United States, 19102
Principal Investigator: Site Reference ID/Investigator# 107195         
Site Reference ID/Investigator# 105516 Recruiting
Pittsburgh, Pennsylvania, United States, 15243
Principal Investigator: Site Reference ID/Investigator# 105516         
United States, South Carolina
Site Reference ID/Investigator# 105175 Recruiting
Columbia, South Carolina, United States, 29203
Principal Investigator: Site Reference ID/Investigator# 105175         
Site Reference ID/Investigator# 107197 Recruiting
Myrtle Beach, South Carolina, United States, 29572
Principal Investigator: Site Reference ID/Investigator# 107197         
Site Reference ID/Investigator# 96612 Recruiting
Orangeburg, South Carolina, United States, 29118
Principal Investigator: Site Reference ID/Investigator# 96612         
United States, Tennessee
Site Reference ID/Investigator# 106301 Recruiting
Jackson, Tennessee, United States, 38305
Principal Investigator: Site Reference ID/Investigator# 106301         
Site Reference ID/Investigator# 105200 Recruiting
Knoxville, Tennessee, United States, 37923
Principal Investigator: Site Reference ID/Investigator# 105200         
Site Reference ID/Investigator# 103015 Recruiting
Memphis, Tennessee, United States, 38163
Principal Investigator: Site Reference ID/Investigator# 103015         
United States, Texas
Site Reference ID/Investigator# 99976 Recruiting
Corpus Christi, Texas, United States, 78414
Principal Investigator: Site Reference ID/Investigator# 99976         
Site Reference ID/Investigator# 105600 Recruiting
Dallas, Texas, United States, 75218
Principal Investigator: Site Reference ID/Investigator# 105600         
Site Reference ID/Investigator# 107955 Recruiting
Dallas, Texas, United States, 75231
Principal Investigator: Site Reference ID/Investigator# 107955         
Site Reference ID/Investigator# 105159 Recruiting
Fort Worth, Texas, United States, 76104
Principal Investigator: Site Reference ID/Investigator# 105159         
Site Reference ID/Investigator# 111222 Recruiting
Greenville, Texas, United States, 75402
Principal Investigator: Site Reference ID/Investigator# 111222         
Site Reference ID/Investigator# 100455 Recruiting
Houston, Texas, United States, 77024
Principal Investigator: Site Reference ID/Investigator# 100455         
Site Reference ID/Investigator# 116175 Recruiting
Houston, Texas, United States, 77055
Principal Investigator: Site Reference ID/Investigator# 116175         
Site Reference ID/Investigator# 99896 Recruiting
Houston, Texas, United States, 77004
Principal Investigator: Site Reference ID/Investigator# 99896         
Site Reference ID/Investigator# 105336 Recruiting
Houston, Texas, United States, 77024
Principal Investigator: Site Reference ID/Investigator# 105336         
Site Reference ID/Investigator# 113455 Recruiting
Houston, Texas, United States, 77004
Principal Investigator: Site Reference ID/Investigator# 113455         
Site Reference ID/Investigator# 112917 Recruiting
Houston, Texas, United States, 77055
Principal Investigator: Site Reference ID/Investigator# 112917         
Site Reference ID/Investigator# 105575 Recruiting
Houston, Texas, United States, 77004
Principal Investigator: Site Reference ID/Investigator# 105575         
Site Reference ID/Investigator# 114937 Recruiting
Houston, Texas, United States, 77004
Principal Investigator: Site Reference ID/Investigator# 114937         
Site Reference ID/Investigator# 107201 Not yet recruiting
Houston, Texas, United States, 77030
Principal Investigator: Site Reference ID/Investigator# 107201         
Site Reference ID/Investigator# 112901 Recruiting
Houston, Texas, United States, 77025
Principal Investigator: Site Reference ID/Investigator# 112901         
Site Reference ID/Investigator# 96705 Not yet recruiting
Lubbock, Texas, United States, 79430
Principal Investigator: Site Reference ID/Investigator# 96705         
Site Reference ID/Investigator# 105735 Recruiting
Lubbock, Texas, United States, 79423
Principal Investigator: Site Reference ID/Investigator# 105735         
Site Reference ID/Investigator# 106815 Recruiting
Lufkin, Texas, United States, 75904
Principal Investigator: Site Reference ID/Investigator# 106815         
Site Reference ID/Investigator# 96608 Recruiting
McAllen, Texas, United States, 78503
Principal Investigator: Site Reference ID/Investigator# 96608         
Site Reference ID/Investigator# 111217 Recruiting
McKinney, Texas, United States, 75069
Principal Investigator: Site Reference ID/Investigator# 111217         
Site Reference ID/Investigator# 109416 Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Site Reference ID/Investigator# 109416         
Site Reference ID/Investigator# 104913 Recruiting
San Antonio, Texas, United States, 78224
Principal Investigator: Site Reference ID/Investigator# 104913         
Site Reference ID/Investigator# 96615 Recruiting
San Antonio, Texas, United States, 78215
Principal Investigator: Site Reference ID/Investigator# 96615         
Site Reference ID/Investigator# 114817 Recruiting
Weslaco, Texas, United States, 78596
Principal Investigator: Site Reference ID/Investigator# 114817         
United States, Utah
Site Reference ID/Investigator# 105157 Recruiting
Ogden, Utah, United States, 84405
Principal Investigator: Site Reference ID/Investigator# 105157         
Site Reference ID/Investigator# 118547 Recruiting
Saint George, Utah, United States, 84770
Principal Investigator: Site Reference ID/Investigator# 118547         
United States, Vermont
Site Reference ID/Investigator# 107376 Recruiting
Burlington, Vermont, United States, 05401
Principal Investigator: Site Reference ID/Investigator# 107376         
Site Reference ID/Investigator# 109916 Withdrawn
Burlington, Vermont, United States, 05401
United States, Virginia
Site Reference ID/Investigator# 105202 Recruiting
Fairfax, Virginia, United States, 22033
Principal Investigator: Site Reference ID/Investigator# 105202         
United States, Washington
Site Reference ID/Investigator# 105435 Recruiting
Everett, Washington, United States, 98201
Principal Investigator: Site Reference ID/Investigator# 105435         
Site Reference ID/Investigator# 96621 Not yet recruiting
Silverdale, Washington, United States, 98383
Principal Investigator: Site Reference ID/Investigator# 96621         
Site Reference ID/Investigator# 107959 Recruiting
Spokane, Washington, United States, 99207
Principal Investigator: Site Reference ID/Investigator# 107959         
Site Reference ID/Investigator# 103695 Recruiting
Tacoma, Washington, United States, 98405
Principal Investigator: Site Reference ID/Investigator# 103695         
United States, West Virginia
Site Reference ID/Investigator# 105201 Recruiting
Morgantown, West Virginia, United States, 26506-9165
Principal Investigator: Site Reference ID/Investigator# 105201         
Argentina
Site Reference ID/Investigator# 107356 Not yet recruiting
Avellaneda, Argentina, 1874
Principal Investigator: Site Reference ID/Investigator# 107356         
Site Reference ID/Investigator# 100895 Not yet recruiting
Buenos Aires, Argentina, C1425AGC
Principal Investigator: Site Reference ID/Investigator# 100895         
Site Reference ID/Investigator# 100537 Not yet recruiting
Buenos Aires, Argentina, 1427
Principal Investigator: Site Reference ID/Investigator# 100537         
Site Reference ID/Investigator# 106256 Not yet recruiting
Buenos Aires, Argentina, C1431FWO
Principal Investigator: Site Reference ID/Investigator# 106256         
Site Reference ID/Investigator# 105520 Not yet recruiting
Cordoba, Argentina, X5002HWE
Principal Investigator: Site Reference ID/Investigator# 105520         
Site Reference ID/Investigator# 104776 Not yet recruiting
Cordoba, Argentina, X5000BNB
Principal Investigator: Site Reference ID/Investigator# 104776         
Site Reference ID/Investigator# 100535 Not yet recruiting
Corrientes, Argentina, 3400
Principal Investigator: Site Reference ID/Investigator# 100535         
Site Reference ID/Investigator# 100536 Not yet recruiting
Junin, Argentina, B6000GPB
Principal Investigator: Site Reference ID/Investigator# 100536         
Site Reference ID/Investigator# 106255 Not yet recruiting
Mar del Plata, Argentina, B7600DHK
Principal Investigator: Site Reference ID/Investigator# 106255         
Site Reference ID/Investigator# 105057 Not yet recruiting
Pergamino, Argentina, B2700CPM
Principal Investigator: Site Reference ID/Investigator# 105057         
Site Reference ID/Investigator# 104775 Not yet recruiting
San Miguel de Tucuman, Argentina, 4000
Principal Investigator: Site Reference ID/Investigator# 104775         
Australia
Site Reference ID/Investigator# 110535 Recruiting
Fremantle, Australia, 6160
Principal Investigator: Site Reference ID/Investigator# 110535         
Brazil
Site Reference ID/Investigator# 104358 Not yet recruiting
Porto Alegre, Brazil, 90035-074
Principal Investigator: Site Reference ID/Investigator# 104358         
Site Reference ID/Investigator# 104357 Not yet recruiting
Sao Paulo, Brazil, 01223-001
Principal Investigator: Site Reference ID/Investigator# 104357         
Site Reference ID/Investigator# 100538 Not yet recruiting
Sao Paulo, Brazil, 04011-030
Principal Investigator: Site Reference ID/Investigator# 100538         
Canada
Site Reference ID/Investigator# 103981 Recruiting
Brampton, Canada, L6S 0C9
Principal Investigator: Site Reference ID/Investigator# 103981         
Site Reference ID/Investigator# 107875 Recruiting
Burlington, Canada, L7M 4Y1
Principal Investigator: Site Reference ID/Investigator# 107875         
Site Reference ID/Investigator# 105676 Recruiting
Courtice, Canada, L1E 3C3
Principal Investigator: Site Reference ID/Investigator# 105676         
Site Reference ID/Investigator# 100117 Recruiting
East York, Canada, M4C 5T2
Principal Investigator: Site Reference ID/Investigator# 100117         
Site Reference ID/Investigator# 103982 Recruiting
Etobicoke, Canada, M9R 4E1
Principal Investigator: Site Reference ID/Investigator# 103982         
Site Reference ID/Investigator# 99395 Recruiting
Kitchener, Canada, N2H 5Z8
Principal Investigator: Site Reference ID/Investigator# 99395         
Site Reference ID/Investigator# 100115 Recruiting
Scarborough, Canada, M1H 3G4
Principal Investigator: Site Reference ID/Investigator# 100115         
Site Reference ID/Investigator# 118543 Recruiting
Sudbury, Canada, P3E 1H5
Principal Investigator: Site Reference ID/Investigator# 118543         
Site Reference ID/Investigator# 104835 Recruiting
Toronto, Canada, M4G 3E8
Principal Investigator: Site Reference ID/Investigator# 104835         
Site Reference ID/Investigator# 101537 Not yet recruiting
Winnipeg, Canada, R3E 3P4
Principal Investigator: Site Reference ID/Investigator# 101537         
Czech Republic
Site Reference ID/Investigator# 108555 Not yet recruiting
Frydek-Mistek, Czech Republic, 738 01
Principal Investigator: Site Reference ID/Investigator# 108555         
Site Reference ID/Investigator# 108556 Not yet recruiting
Jilemnice, Czech Republic, 514 01
Principal Investigator: Site Reference ID/Investigator# 108556         
Site Reference ID/Investigator# 100557 Not yet recruiting
Olomouc, Czech Republic, 779 00
Principal Investigator: Site Reference ID/Investigator# 100557         
Site Reference ID/Investigator# 103579 Not yet recruiting
Pardubice, Czech Republic, 530 02
Principal Investigator: Site Reference ID/Investigator# 103579         
Site Reference ID/Investigator# 103575 Not yet recruiting
Prague 4, Czech Republic, 149 00
Principal Investigator: Site Reference ID/Investigator# 103575         
Denmark
Site Reference ID/Investigator# 106195 Not yet recruiting
Aarhus C, Denmark, 8000
Principal Investigator: Site Reference ID/Investigator# 106195         
Site Reference ID/Investigator# 103855 Not yet recruiting
Frederiksberg, Denmark, 2000
Principal Investigator: Site Reference ID/Investigator# 103855         
Site Reference ID/Investigator# 104226 Not yet recruiting
Holstebro, Denmark, 7500
Principal Investigator: Site Reference ID/Investigator# 104226         
Site Reference ID/Investigator# 103857 Not yet recruiting
Rosklide, Denmark, 4000
Principal Investigator: Site Reference ID/Investigator# 103857         
Greece
Site Reference ID/Investigator# 109535 Not yet recruiting
Komotini, Greece, 69100
Principal Investigator: Site Reference ID/Investigator# 109535         
Site Reference ID/Investigator# 103963 Not yet recruiting
Patras, Greece, 26504
Principal Investigator: Site Reference ID/Investigator# 103963         
Ireland
Site Reference ID/Investigator# 104075 Not yet recruiting
Cork, Ireland
Principal Investigator: Site Reference ID/Investigator# 104075         
Site Reference ID/Investigator# 111996 Not yet recruiting
Dublin 15, Ireland
Principal Investigator: Site Reference ID/Investigator# 111996         
Site Reference ID/Investigator# 104236 Recruiting
Dublin 4, Ireland
Principal Investigator: Site Reference ID/Investigator# 104236         
Italy
Site Reference ID/Investigator# 111615 Not yet recruiting
Naples, Italy, 80138
Principal Investigator: Site Reference ID/Investigator# 111615         
Japan
Site Reference ID/Investigator# 118159 Recruiting
Akita, Japan
Principal Investigator: Site Reference ID/Investigator# 118159         
Site Reference ID/Investigator# 106355 Recruiting
Asahikawa, Japan
Principal Investigator: Site Reference ID/Investigator# 106355         
Site Reference ID/Investigator# 119495 Not yet recruiting
Asahikawa, Japan
Principal Investigator: Site Reference ID/Investigator# 119495         
Site Reference ID/Investigator# 109476 Recruiting
Asahikawa, Japan
Principal Investigator: Site Reference ID/Investigator# 109476         
Site Reference ID/Investigator# 107575 Recruiting
Chiba, Japan
Principal Investigator: Site Reference ID/Investigator# 107575         
Site Reference ID/Investigator# 119496 Recruiting
Chikushino, Japan
Principal Investigator: Site Reference ID/Investigator# 119496         
Site Reference ID/Investigator# 109497 Recruiting
Chita, Japan
Principal Investigator: Site Reference ID/Investigator# 109497         
Site Reference ID/Investigator# 110775 Recruiting
Fukuoka, Japan
Principal Investigator: Site Reference ID/Investigator# 110775         
Site Reference ID/Investigator# 108775 Recruiting
Fukuoka, Japan
Principal Investigator: Site Reference ID/Investigator# 108775         
Site Reference ID/Investigator# 109498 Recruiting
Fukuyama, Japan
Principal Investigator: Site Reference ID/Investigator# 109498         
Site Reference ID/Investigator# 111055 Recruiting
Fukuyama, Japan
Principal Investigator: Site Reference ID/Investigator# 111055         
Site Reference ID/Investigator# 110795 Recruiting
Funabashi, Japan
Principal Investigator: Site Reference ID/Investigator# 110795         
Site Reference ID/Investigator# 109481 Recruiting
Hakodate, Japan
Principal Investigator: Site Reference ID/Investigator# 109481         
Site Reference ID/Investigator# 109480 Recruiting
Hakodate, Japan
Principal Investigator: Site Reference ID/Investigator# 109480         
Site Reference ID/Investigator# 109495 Recruiting
Hakodate, Japan
Principal Investigator: Site Reference ID/Investigator# 109495         
Site Reference ID/Investigator# 108177 Recruiting
Hamamatsu, Japan
Principal Investigator: Site Reference ID/Investigator# 108177         
Site Reference ID/Investigator# 105207 Recruiting
Higashihiroshima, Japan
Principal Investigator: Site Reference ID/Investigator# 105207         
Site Reference ID/Investigator# 108178 Recruiting
Ibaraki, Japan
Principal Investigator: Site Reference ID/Investigator# 108178         
Site Reference ID/Investigator# 108176 Recruiting
Iwata, Japan
Principal Investigator: Site Reference ID/Investigator# 108176         
Site Reference ID/Investigator# 107056 Recruiting
Izumisano, Japan
Principal Investigator: Site Reference ID/Investigator# 107056         
Site Reference ID/Investigator# 111056 Recruiting
Izumo, Japan
Principal Investigator: Site Reference ID/Investigator# 111056         
Site Reference ID/Investigator# 119138 Recruiting
Kagoshima, Japan
Principal Investigator: Site Reference ID/Investigator# 119138         
Site Reference ID/Investigator# 117619 Recruiting
Kagoshima, Japan
Principal Investigator: Site Reference ID/Investigator# 117619         
Site Reference ID/Investigator# 119140 Recruiting
Kawanishi, Japan
Principal Investigator: Site Reference ID/Investigator# 119140         
Site Reference ID/Investigator# 110756 Recruiting
Kawasaki, Japan
Principal Investigator: Site Reference ID/Investigator# 110756         
Site Reference ID/Investigator# 109499 Recruiting
Kitakyushu, Japan
Principal Investigator: Site Reference ID/Investigator# 109499         
Site Reference ID/Investigator# 110755 Recruiting
Kobe, Japan
Principal Investigator: Site Reference ID/Investigator# 110755         
Site Reference ID/Investigator# 119577 Recruiting
Kobe, Japan
Principal Investigator: Site Reference ID/Investigator# 119577         
Site Reference ID/Investigator# 118515 Recruiting
Koga, Japan
Principal Investigator: Site Reference ID/Investigator# 118515         
Site Reference ID/Investigator# 106335 Recruiting
Koshigaya, Japan
Principal Investigator: Site Reference ID/Investigator# 106335         
Site Reference ID/Investigator# 118516 Recruiting
Koshigaya, Japan
Principal Investigator: Site Reference ID/Investigator# 118516         
Site Reference ID/Investigator# 105206 Recruiting
Kumamoto, Japan
Principal Investigator: Site Reference ID/Investigator# 105206         
Site Reference ID/Investigator# 102635 Not yet recruiting
Kurashiki, Japan
Principal Investigator: Site Reference ID/Investigator# 102635         
Site Reference ID/Investigator# 108696 Recruiting
Kurume, Japan
Principal Investigator: Site Reference ID/Investigator# 108696         
Site Reference ID/Investigator# 107055 Recruiting
Kyoto, Japan
Principal Investigator: Site Reference ID/Investigator# 107055         
Site Reference ID/Investigator# 109477 Recruiting
Kyoto, Japan
Principal Investigator: Site Reference ID/Investigator# 109477         
Site Reference ID/Investigator# 109501 Recruiting
Kyoto, Japan
Principal Investigator: Site Reference ID/Investigator# 109501         
Site Reference ID/Investigator# 108204 Recruiting
Matsue, Japan
Principal Investigator: Site Reference ID/Investigator# 108204         
Site Reference ID/Investigator# 119638 Not yet recruiting
Matsuyama, Japan
Principal Investigator: Site Reference ID/Investigator# 119638         
Site Reference ID/Investigator# 105218 Recruiting
Matsuyama, Japan
Principal Investigator: Site Reference ID/Investigator# 105218         
Site Reference ID/Investigator# 119136 Recruiting
Miyazaki, Japan
Principal Investigator: Site Reference ID/Investigator# 119136         
Site Reference ID/Investigator# 118157 Recruiting
Muroran, Japan
Principal Investigator: Site Reference ID/Investigator# 118157         
Site Reference ID/Investigator# 107557 Recruiting
Nagoya, Japan
Principal Investigator: Site Reference ID/Investigator# 107557         
Site Reference ID/Investigator# 108195 Recruiting
Nagoya, Japan
Principal Investigator: Site Reference ID/Investigator# 108195         
Site Reference ID/Investigator# 107035 Recruiting
Nagoya, Japan
Principal Investigator: Site Reference ID/Investigator# 107035         
Site Reference ID/Investigator# 107037 Recruiting
Naka, Japan
Principal Investigator: Site Reference ID/Investigator# 107037         
Site Reference ID/Investigator# 107558 Recruiting
Niigata, Japan
Principal Investigator: Site Reference ID/Investigator# 107558         
Site Reference ID/Investigator# 119141 Recruiting
Noda, Japan
Principal Investigator: Site Reference ID/Investigator# 119141         
Site Reference ID/Investigator# 109479 Recruiting
Obihiro, Japan
Principal Investigator: Site Reference ID/Investigator# 109479         
Site Reference ID/Investigator# 109500 Recruiting
Okawa, Japan
Principal Investigator: Site Reference ID/Investigator# 109500         
Site Reference ID/Investigator# 107616 Recruiting
Okinawa, Japan
Principal Investigator: Site Reference ID/Investigator# 107616         
Site Reference ID/Investigator# 119636 Not yet recruiting
Osaka, Japan
Principal Investigator: Site Reference ID/Investigator# 119636         
Site Reference ID/Investigator# 117755 Recruiting
Osaka, Japan
Principal Investigator: Site Reference ID/Investigator# 117755         
Site Reference ID/Investigator# 109478 Recruiting
Saku, Japan
Principal Investigator: Site Reference ID/Investigator# 109478         
Site Reference ID/Investigator# 108735 Recruiting
Sanuki, Japan
Principal Investigator: Site Reference ID/Investigator# 108735         
Site Reference ID/Investigator# 107615 Recruiting
Sapporo, Japan
Principal Investigator: Site Reference ID/Investigator# 107615         
Site Reference ID/Investigator# 107560 Recruiting
Shiga, Japan
Principal Investigator: Site Reference ID/Investigator# 107560         
Site Reference ID/Investigator# 106357 Recruiting
Shizuoka, Japan
Principal Investigator: Site Reference ID/Investigator# 106357         
Site Reference ID/Investigator# 117756 Recruiting
Shunan, Japan
Principal Investigator: Site Reference ID/Investigator# 117756         
Site Reference ID/Investigator# 107559 Recruiting
Takamatsu, Japan
Principal Investigator: Site Reference ID/Investigator# 107559         
Site Reference ID/Investigator# 107038 Recruiting
Takatsuki, Japan
Principal Investigator: Site Reference ID/Investigator# 107038         
Site Reference ID/Investigator# 108676 Recruiting
Tamana, Japan
Principal Investigator: Site Reference ID/Investigator# 108676         
Site Reference ID/Investigator# 105217 Recruiting
Tokushima, Japan
Principal Investigator: Site Reference ID/Investigator# 105217         
Site Reference ID/Investigator# 117757 Not yet recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 117757         
Site Reference ID/Investigator# 108675 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 108675         
Site Reference ID/Investigator# 108175 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 108175         
Site Reference ID/Investigator# 121200 Not yet recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 121200         
Site Reference ID/Investigator# 107057 Recruiting
Toride, Japan
Principal Investigator: Site Reference ID/Investigator# 107057         
Site Reference ID/Investigator# 109502 Recruiting
Toyota, Japan
Principal Investigator: Site Reference ID/Investigator# 109502         
Site Reference ID/Investigator# 107036 Recruiting
Tsu, Japan
Principal Investigator: Site Reference ID/Investigator# 107036         
Site Reference ID/Investigator# 106356 Recruiting
Ueda, Japan
Principal Investigator: Site Reference ID/Investigator# 106356         
Site Reference ID/Investigator# 109475 Recruiting
Yaizu, Japan
Principal Investigator: Site Reference ID/Investigator# 109475         
Site Reference ID/Investigator# 119578 Recruiting
Yokohama, Japan
Principal Investigator: Site Reference ID/Investigator# 119578         
Site Reference ID/Investigator# 108196 Recruiting
Yokohama, Japan
Principal Investigator: Site Reference ID/Investigator# 108196         
Malaysia
Site Reference ID/Investigator# 113819 Not yet recruiting
Seremban, Malaysia, 70300
Principal Investigator: Site Reference ID/Investigator# 113819         
New Zealand
Site Reference ID/Investigator# 102595 Not yet recruiting
Dunedin, New Zealand, 9016
Principal Investigator: Site Reference ID/Investigator# 102595         
Site Reference ID/Investigator# 110575 Not yet recruiting
Hamilton, New Zealand, 3240
Principal Investigator: Site Reference ID/Investigator# 110575         
Site Reference ID/Investigator# 110576 Not yet recruiting
New Plymouth, New Zealand, 4310
Principal Investigator: Site Reference ID/Investigator# 110576         
Puerto Rico
Site Reference ID/Investigator# 104855 Recruiting
Caguas, Puerto Rico, 00725
Principal Investigator: Site Reference ID/Investigator# 104855         
Site Reference ID/Investigator# 106295 Recruiting
Rio Grande, Puerto Rico, 00745
Principal Investigator: Site Reference ID/Investigator# 106295         
Site Reference ID/Investigator# 104857 Recruiting
Rio Piedras, Puerto Rico, 00935
Principal Investigator: Site Reference ID/Investigator# 104857         
Site Reference ID/Investigator# 103455 Recruiting
San Juan, Puerto Rico, 00935
Principal Investigator: Site Reference ID/Investigator# 103455         
Site Reference ID/Investigator# 105675 Recruiting
Santurce, Puerto Rico, 00909-2244
Principal Investigator: Site Reference ID/Investigator# 105675         
Spain
Site Reference ID/Investigator# 104095 Not yet recruiting
A Coruna, Spain, 15006
Principal Investigator: Site Reference ID/Investigator# 104095         
Site Reference ID/Investigator# 103717 Not yet recruiting
Badalona - Barcelona, Spain, 08916
Principal Investigator: Site Reference ID/Investigator# 103717         
Site Reference ID/Investigator# 103136 Recruiting
Barcelona, Spain, 08907
Principal Investigator: Site Reference ID/Investigator# 103136         
Site Reference ID/Investigator# 100330 Recruiting
Barcelona, Spain, 08003
Principal Investigator: Site Reference ID/Investigator# 100330         
Site Reference ID/Investigator# 107458 Recruiting
Barcelona, Spain, 08025
Principal Investigator: Site Reference ID/Investigator# 107458         
Site Reference ID/Investigator# 104660 Recruiting
Barcelona, Spain, 08025
Principal Investigator: Site Reference ID/Investigator# 104660         
Site Reference ID/Investigator# 100572 Recruiting
Burela, Spain, 27880
Principal Investigator: Site Reference ID/Investigator# 100572         
Site Reference ID/Investigator# 107816 Recruiting
Cordoba, Spain, 14004
Principal Investigator: Site Reference ID/Investigator# 107816         
Site Reference ID/Investigator# 100574 Recruiting
Girona, Spain, 17007
Principal Investigator: Site Reference ID/Investigator# 100574         
Site Reference ID/Investigator# 109456 Not yet recruiting
Lleida, Spain, 25198
Principal Investigator: Site Reference ID/Investigator# 109456         
Site Reference ID/Investigator# 100573 Recruiting
Madrid, Spain, 28922
Principal Investigator: Site Reference ID/Investigator# 100573         
Site Reference ID/Investigator# 106218 Recruiting
Madrid, Spain, 28041
Principal Investigator: Site Reference ID/Investigator# 106218         
Site Reference ID/Investigator# 104222 Recruiting
Madrid, Spain, 28040
Principal Investigator: Site Reference ID/Investigator# 104222         
Site Reference ID/Investigator# 104661 Recruiting
Malaga, Spain, 29006
Principal Investigator: Site Reference ID/Investigator# 104661         
Site Reference ID/Investigator# 106215 Recruiting
Oviedo, Spain, 33006
Principal Investigator: Site Reference ID/Investigator# 106215         
Site Reference ID/Investigator# 106217 Recruiting
Seville, Spain, 41071
Principal Investigator: Site Reference ID/Investigator# 106217         
Site Reference ID/Investigator# 107997 Not yet recruiting
Tenerife, Spain, 38010
Principal Investigator: Site Reference ID/Investigator# 107997         
Site Reference ID/Investigator# 105517 Recruiting
Valencia, Spain, 46017
Principal Investigator: Site Reference ID/Investigator# 105517         
United Kingdom
Site Reference ID/Investigator# 106235 Not yet recruiting
London, United Kingdom, SE1 9RT
Principal Investigator: Site Reference ID/Investigator# 106235         
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Blai Coll, MD AbbVie Inc.
  More Information

No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01858532     History of Changes
Other Study ID Numbers: M11-352, 2012-005848-21
Study First Received: May 17, 2013
Last Updated: January 5, 2014
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration
Peru: Instituto Nacional de Salud
Slovakia: State Institute for Drug Control
Switzerland: Swissmedic
Malaysia: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
Israel: Ministry of Health
Greece: National Organization of Medicines
Russia: Ministry of Health of the Russian Federation
Poland: Ministry of Health
Hong Kong: Department of Health
Sweden: Medical Products Agency
Denmark: Danish Medicines Agency
Turkey: Ministry of Health
Italy: Ethics Committee
Portugal: National Pharmacy and Medicines Institute
Australia: Department of Health and Ageing Therapeutic Goods Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Ireland: Irish Medicines Board
Taiwan : Food and Drug Administration
South Africa: Medicines Control Council
Finland: Finnish Medicines Agency
Ukraine: Ministry of Health
New Zealand: Medsafe
Czech Republic: State Institute for Drug Control
Japan: Pharmaceuticals and Medical Devices Agency
Germany: Federal Institute for Drugs and Medical Devices
Belgium: Federal Agency for Medicinal Products and Health Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Brazil: National Health Surveillance Agency
Netherlands: Medicines Evaluation Board (MEB)
Bulgaria: Bulgarian Drug Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Mexico: Federal Commission for Protection Against Health Risks
Chile: Instituto de Salud Publica de Chile
Singapore: Health Sciences Authority
Romania: National Agency for Medicines and Medical Devices
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by AbbVie:
Nephropathy
Diabetes

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014