Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease
NCT ID: NCT00296374
Last Updated: 2011-09-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
353 participants
INTERVENTIONAL
2006-02-28
2009-03-31
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
QUADRUPLE
Study Groups
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1
Rosuvastatin 10 mg
Rosuvastatin
10 mg oral dose administered once daily for 52 weeks
2
Rosuvastatin 40 mg
Rosuvastatin
20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks
3
Atorvastatin 80 mg
Atorvastatin
40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once daily for 48 weeks
Interventions
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Rosuvastatin
10 mg oral dose administered once daily for 52 weeks
Rosuvastatin
20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks
Atorvastatin
40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once daily for 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* urinary protein
* diabetes
Exclusion Criteria
* statin intolerance
* severe hypertension
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca Crestor Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Avondale, Arizona, United States
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Phoenix, Arizona, United States
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Jonesboro, Arkansas, United States
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Pasadena, California, United States
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Riverside, California, United States
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Santa Ana, California, United States
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West Hills, California, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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West Palm Beach, Florida, United States
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Augusta, Georgia, United States
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Topeka, Kansas, United States
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Springfield, Massachusetts, United States
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Detroit, Michigan, United States
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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Orchard Park, New York, United States
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Stony Brook, New York, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Kettering, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Columbia, South Carolina, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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San Antonio, Texas, United States
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Ogden, Utah, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, , Argentina
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La Plata, , Argentina
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Morón, , Argentina
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Quilmes, , Argentina
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Curitiba, , Brazil
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Fortaleza, , Brazil
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Goiânia, , Brazil
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Recife, , Brazil
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São Paulo, , Brazil
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Burgas, , Bulgaria
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Gabrovo, , Bulgaria
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Veliko Tarnovo, , Bulgaria
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Vancouver, British Columbia, Canada
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Courtice, Ontario, Canada
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North York, Ontario, Canada
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Richmond Hill, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Aalborg, , Denmark
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Blegdamsvej 9, , Denmark
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Farsø, , Denmark
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Gentofte Municipality, , Denmark
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Hillerød, , Denmark
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Hvidovre, , Denmark
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Køge, , Denmark
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Annonay, , France
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Besançon, , France
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Bondy, , France
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Colmar, , France
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Corbeil-Essonnes, , France
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Corsept, , France
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Creil, , France
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Grenoble, , France
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La Chapelle-sur-Erdre, , France
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Nantes, , France
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Paris, , France
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Pessac, , France
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Quimper, , France
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Baja, , Hungary
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Balatonfüred, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Győr, , Hungary
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Gyula, , Hungary
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Hodmeztvasarhely, , Hungary
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Kecskemét, , Hungary
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Keszthely, , Hungary
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Miskolc, , Hungary
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Mosonmagyaróvár, , Hungary
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Nyíregyháza, , Hungary
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Székesfehérvár, , Hungary
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Szolnok, , Hungary
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Tatabánya, , Hungary
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Zalaegerszeg, , Hungary
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Acireale, CT, Italy
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Florence, FI, Italy
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Roma, RM, Italy
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Sottomarnia Di Chioggia, VE, Italy
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Bergamo, , Italy
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Cagliari, , Italy
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Milan, , Italy
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San Giovanni Rotondo, , Italy
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Sassari, , Italy
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Treviglio, , Italy
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Aguascalientes, , Mexico
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Cauntla, , Mexico
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Distrito Federal, , Mexico
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Durango, , Mexico
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Guadalajara, , Mexico
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Saltillo, , Mexico
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San Luis Potosí City, , Mexico
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Zapopan, , Mexico
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Baia Mare, , Romania
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Brasov, , Romania
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Bucharest, , Romania
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Craiova, , Romania
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Lasi, , Romania
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Târgu Mureş, , Romania
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Timișoara, , Romania
Countries
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References
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Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
de Zeeuw D, Anzalone DA, Cain VA, Cressman MD, Heerspink HJ, Molitoris BA, Monyak JT, Parving HH, Remuzzi G, Sowers JR, Vidt DG. Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I): a randomised clinical trial. Lancet Diabetes Endocrinol. 2015 Mar;3(3):181-90. doi: 10.1016/S2213-8587(14)70246-3. Epub 2015 Feb 4.
Other Identifiers
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PLANET 1
Identifier Type: -
Identifier Source: secondary_id
D3569C00007
Identifier Type: -
Identifier Source: org_study_id
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