A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy
NCT ID: NCT01200394
Last Updated: 2019-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
256 participants
INTERVENTIONAL
2010-12-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PF-00489791
PF-00489791
Tablet, 20 mg once daily for 12 weeks
Placebo
Placebo
Tablet, placebo once daily for 12 weeks
Interventions
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PF-00489791
Tablet, 20 mg once daily for 12 weeks
Placebo
Tablet, placebo once daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of type 2 diabetes together with stages 3a, 3b or 4 CKD, based on an eGFR of 25-59 mL/min/1.73m2.
* Evidence of persistent, overt albuminuria; defined as a UACR greater than or equal to 300 mg/g (greater than or equal to 33.9 mg/mmol) for greater than 3 months.
Exclusion Criteria
* Subjects with poorly controlled diabetes mellitus, defined as HbA1C \>9%.
* Subjects on combination ACE inhibitor/ARB therapy.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Saadat Ansari Internal Medicine
Huntsville, Alabama, United States
The Office of Iqbal Saeed MD, LLC
Huntsville, Alabama, United States
AKDHC Medical Research Services, LLC*
Glendale, Arizona, United States
Southwest Clinical Research Institute, LLC
Tempe, Arizona, United States
Southwest Clinical Research Institute, LLC
Tempe, Arizona, United States
North America Research Institute
Azusa, California, United States
North American Research Institute / California Kidney Specialist
Azusa, California, United States
Citrus Dialysis Center
Covina, California, United States
California Institute of Renal Research
La Mesa, California, United States
Capital Nephrology Clinical Research
Sacramento, California, United States
California Kidney Specialists
San Dimas, California, United States
American Institute of Research
Whittier, California, United States
Whittier Internal Medicine Nephrology Medical Group
Whittier, California, United States
North Valley Nephrology
Yuba City, California, United States
Riverside Clinical Research
Edgewater, Florida, United States
Palm Springs Research Institute
Hialeah, Florida, United States
ASA Clinical Research, LLC
Jupiter, Florida, United States
Lakeview Medical Research
Summerfield, Florida, United States
Rockdale Medical Research Associates
Conyers, Georgia, United States
Renal Physicians of Georgia
Macon, Georgia, United States
Boise Kidney and Hypertension Institute
Meridian, Idaho, United States
Chicago Clinical Research Institute, Inc.
Chicago, Illinois, United States
Associates in Nephrology, SC
Evergreen Park, Illinois, United States
Research by Design, LLC
Evergreen Park, Illinois, United States
RenalCare Associates
Peoria, Illinois, United States
Investigative Clinical Research of Indiana, LLC
Elwood, Indiana, United States
Kansas Nephrology Research Institute, LLC
Wichita, Kansas, United States
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, United States
Crescent City Clinical Research Center
Metairie, Louisiana, United States
Northwest Louisiana Nephrology
Shreveport, Louisiana, United States
Biolab Research, LLC
Rockville, Maryland, United States
Alzohaili Medical Consultants
Dearborn, Michigan, United States
Apex Medical Research, AMR, Inc.
Flint, Michigan, United States
Apex Medical Research, MI, Inc.
Flint, Michigan, United States
Clinical Research Consultants, LLC
Kansas City, Missouri, United States
Lincoln Nephrology and Hypertension
Lincoln, Nebraska, United States
Nebraska Nephrology Research Institute, LLC - Research Management, Inc.
Lincoln, Nebraska, United States
Alliance Against Diabetes
Las Vegas, Nevada, United States
Clinical Research Consortium
Las Vegas, Nevada, United States
Jacobi Medical Center - Department of Medicine - Nephrology
The Bronx, New York, United States
Mountain Kidney and Hypertension Associates, PA
Asheville, North Carolina, United States
Trial Management Associates
Wilmington, North Carolina, United States
Lake Medical Research
Willoughby Hills, Ohio, United States
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, United States
Preferred Primary Care Physicians, Inc.
Uniontown, Pennsylvania, United States
Columbia Nephrology Associates, PA
Columbia, South Carolina, United States
Carolina Nephrology, PA
Greenville, South Carolina, United States
Palmetto Nephrology, PA
Orangeburg, South Carolina, United States
South Carolina Nephrology & Hypertension Ctr, Inc
Orangeburg, South Carolina, United States
South Carolina Nephrology and Hypertension Center
Orangeburg, South Carolina, United States
Central Texas Kidney Associates
Austin, Texas, United States
Research Management, Inc.
Austin, Texas, United States
Diagnostic Clinic of Houston, PA
Houston, Texas, United States
Houston Nephrology Research
Houston, Texas, United States
Research Across America
Houston, Texas, United States
Renal Associates, PA
San Antonio, Texas, United States
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
San Antonio, Texas, United States
Nephrology Associates of Northern Virginia, Inc.
Fairfax, Virginia, United States
Nephrology Specialists, P.C.
Mechanicsville, Virginia, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
Renal Remission & Hypertension Consultants, PLLC
Bremerton, Washington, United States
Sound Medical Research
Port Orchard, Washington, United States
Renal Remission and Hypertension Clinic
Silverdale, Washington, United States
Renal Research Practice
Gosford, New South Wales, Australia
John Hunter Hospital
Newcastle, New South Wales, Australia
Department of Nephrology
New Lambton, Newcastle, Australia
Pharmacy Department
New Lambton, Newcastle, Australia
Melbourne Renal Research Group
Reservoir, Victoria, Australia
Sheldon M Chumir Health Centre
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Entralogix Clincal Research Inc.
Brampton, Ontario, Canada
Entralogix Clinical Research Inc.
Brampton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Entralogix Clinical Research Inc.
Oakville, Ontario, Canada
N/A - formerly with Entralogix SMO
Toronto, Ontario, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Centre de sante et de services sociaux champlain-Charles-Le Moyne
Greenfield Park, Quebec, Canada
Centre de Dialyse de Bois de Boulogne
Montreal, Quebec, Canada
Hopital de Sacre Coeur de Montreal
Montreal, Quebec, Canada
Saskatoon Nephrology Group, Nurses Redisence
Saskatoon, Saskatchewan, Canada
Saskatoon Nephrology Group, Nurses Residence
Saskatoon, Saskatchewan, Canada
Saskatoon Nephrology Group
Saskatoon, Saskatchewan, Canada
Aarhus Universitetshospital (Aarhus Sygehus)
Aarhus, , Denmark
Rigshospitalet
Copenhagen Oe, , Denmark
Steno Diabetes Center
Gentofte Municipality, , Denmark
Queen Mary Hospital
Hong Kong, , Hong Kong
Division of Nephrology, Dept. of Medicine
Pokfulam, , Hong Kong
Division of Nephrology
Pokfulam, , Hong Kong
ICON Clinical Research
Quarry Bay, , Hong Kong
Prince of Wales Hospital
Shatin, , Hong Kong
Apollo Hospitals
Hyderabad, Andhra Pradesh, India
Gujarat Kidney Foundation
Ahmedabad, Gujarat, India
Shrushrut Clinical Research Association
Ahmedabad, Gujarat, India
P. D. Hinduja National Hospital and Medical Research Centre
Mumbai, Maharashtra, India
Pfizer Centre
Mumbai, Maharashtra, India
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, India
Diabetes Care and Research Centre
Pune, Maharashtra, India
KE.M Hospital Research Centre
Pune, Maharashtra, India
King Edward Memorial Hospital
Pune, Maharashtra, India
Jehangir Clinical Development Centre Pvt. Ltd.
Pune, Maharashtra, India
Universiti Sains Malaysia
Kota Bharu, Kelantan, Malaysia
Unit Kajian Klinikal, Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia
Hospital Taiping
Taiping, Perak, Malaysia
Clinical Research Centre, Hospital Pulau Pinang
George Town, Pulau Pinang, Malaysia
Hospital Pulau Pinang
George Town, Pulau Pinang, Malaysia
Nephrology Clinic, Queen Elizabeth Hospital
Kota Kinabalu, Sabah, Malaysia
Unit Hemodialisis, Hospital Serdang
Kajang, Selangor, Malaysia
ICLE SC
Guadalajara, Jalisco, Mexico
Comite Mexicano para la Prevencion de la Osteoporosis, A.C.
Mexico City, Mexico City, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ)
Tlalpan, Mexico City, Mexico
Hospital Central Dr Ignacio Morones Prieto Unidad Regional de Osteoporosis
San Luis Potosí City, San Luis Potosí, Mexico
Hospital Angeles del Pedregal
Angeles Del Pedregal Cp., , Mexico
NZOZ "DIAGNOMED" S.C., Poradnia Nefrologiczna
Bielsko-Biala, , Poland
Samodzielny Publiczny Szpital Kliniczny im Andrzeja Mieleckiego
Katowice, , Poland
NZOZ PS "Medica"
Lublin, , Poland
Centrum Medyczne "Osteomed" NZOZ, Lecznica Specjalistow
Warsaw, , Poland
Centrum Medyczne "OSTEOMED" NZOZ
Warsaw, , Poland
Centrum Medyczne "Osteomed"
Warsaw, , Poland
Centrum Medyczne OSTEOMED NZOZ; Lecznica Specjalistaw
Warsaw, , Poland
Miedzyleski Szpital Specjalistyczny w Warszawie
Warsaw, , Poland
SPZOZ Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego
Wroclaw, , Poland
Clinical Center of Serbia Institute for Endocrinology, Diabetes and Metabolic Diseases
Belgrade, , Serbia
Clinic for Nephrology, Military Medical Academy
Belgrade, , Serbia
Clinical Center of Serbia
Belgrade, , Serbia
Clinical Hospital Center "Zvezdara"
Belgrade, , Serbia
Clinical Hospital Center Zvezdara
Belgrade, , Serbia
Clinic for Endocrinology, Clinical Center Nis
Niš, , Serbia
FNsP Bratislava, Nemocnica Stare Mesto
Bratislava, , Slovakia
Nemocnice s poliklinikami n.o.
Levice, , Slovakia
Fakultna nemocnica s poliklinikou J.A.Reimana Presov
Prešov, , Slovakia
Vseobecna nemocnica Rimavska Sobota
Rimavská Sobota, , Slovakia
Worthwhile Clinical Trials (WWCT), Lake View Hospital
Benoni, Gauteng, South Africa
Dr. George Mukhari Hospital -University of Limpopo
Pretoria, Gauteng, South Africa
Wits Clinical research
Johannesburg, Gauteng- South Africa, South Africa
Centre for Diabetes and Endocrinology
Durban, KwaZulu-Natal, South Africa
Latros International
Bloemfontein, , South Africa
Division of Nephrology and Hypertension, E13 Renal Unit
Cape Town, , South Africa
St Augustine's Hospital
Durban, , South Africa
Centre for Diabetes and Endocrinology
Durban, , South Africa
Centre for Diabetes and Endocrinology
Houghton, Johannesburg, , South Africa
Intercare Parow Medical and Dental Centre
Parow, , South Africa
Medi-Clinic Heart Hospital (Pretoria Heart Hospital)
Pretoria, , South Africa
Pharmacy
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Clinical Trial Pharmacy
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center, Department of Pharmacy
Seoul, , South Korea
Samsung Medical Center,Sungkyunkwan Univ School of Medicine
Seoul, , South Korea
Samsung Medical Center/Division of Nephrology
Seoul, , South Korea
Boramae Medical Center/Division of Nephrology
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
Sahlgrenska University Hospital Njurmottagningen
Gothenburg, , Sweden
A+ Science City site
Stockholm, , Sweden
Akademiska Sjukhuset
Uppsala, , Sweden
Doncaster Royal Infirmary
Doncaster, South Yorkshire, United Kingdom
Research Offices (5th Floor)
Coventry, , United Kingdom
University of Edinburgh
Edinburgh, , United Kingdom
The Royal London Hospital Whitechapel
London, , United Kingdom
Guy's and St Thomas' Foundation Trust
London, , United Kingdom
Northern General Hospital Campus
Sheffield, , United Kingdom
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2010-021358-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A7331011
Identifier Type: -
Identifier Source: org_study_id
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