A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01200394
First received: September 10, 2010
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791 will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure, improving renal function.


Condition Intervention Phase
Diabetic Nephropathies
Drug: PF-00489791
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study To Evaluate The Efficacy And Safety Of Once-Daily Administration Of A Phosphodiesterase 5 Inhibitor (PF-00489791) In Adults With Type 2 Diabetes And Overt Nephropathy

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Urine albumin: creatinine ratio (UACR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urine albumin: creatinine ratio at 3, 6 and 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Urine protein: creatinine ratio at 3, 6, 12 and 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Estimated glomerular filtration rate at 3, 6, 12 and 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Systolic, diastolic and mean arterial blood pressure at 3, 6, 12 and 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Serum creatinine at 3, 6, 12 and 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Urinary TGFbeta1 at Weeks 3, 6, 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Serum C-reactive protein (hs-CRP) at Weeks 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Serum cystatin C at Weeks 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • An assessment of the pharmacokinetic parameters of PF-00489791. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Plasma glycosylated hemoglobin (HbA1c). [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Safety and tolerability measures (AEs, clinical laboratory assessments, physical examination including weight, worsening of edema, increased use of diuretics). [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 256
Study Start Date: October 2010
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-00489791 Drug: PF-00489791
Tablet, 20 mg once daily for 12 weeks
Placebo Comparator: Placebo Drug: Placebo
Tablet, placebo once daily for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects greater than or equal to 18 years. Female subjects must be of non-child bearing potential.
  • 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 CKD resulting from type 1 diabetes or non-diabetic CKD.
  • Subjects with poorly controlled diabetes mellitus, defined as HbA1C >9%.
  • Subjects on combination ACE inhibitor/ARB therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200394

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Locations
United States, Alabama
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Huntsville, Alabama, United States, 35801
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Huntsville, Alabama, United States, 35805
United States, Arizona
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Glendale, Arizona, United States, 85306
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Phoenix, Arizona, United States, 85004
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Tempe, Arizona, United States, 85284
United States, California
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Azusa, California, United States, 91702
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Covina, California, United States, 91723
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La Mesa, California, United States, 91942
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Sacramento, California, United States, 95825
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San Dimas, California, United States, 91773
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Whittier, California, United States, 90602
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Yuba, California, United States, 95991
United States, Florida
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Edgewater, Florida, United States, 32132
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Hialeah, Florida, United States, 33012
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Jupiter, Florida, United States, 33458
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Summerfield, Florida, United States, 34491
United States, Georgia
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Conyers, Georgia, United States, 30094
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Macon, Georgia, United States, 31217
United States, Idaho
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Meridian, Idaho, United States, 83642
United States, Illinois
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Chicago, Illinois, United States, 60616
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Evergreen Park, Illinois, United States, 60805
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Peoria, Illinois, United States, 61603
United States, Indiana
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Elwood, Indiana, United States, 46036
United States, Kansas
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Wichita, Kansas, United States, 67214
United States, Kentucky
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Paducah, Kentucky, United States, 42003
United States, Louisiana
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Metairie, Louisiana, United States, 70006
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Shreveport, Louisiana, United States, 71101
United States, Maryland
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Rockville, Maryland, United States, 20852
United States, Michigan
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Dearborn, Michigan, United States, 48124
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Flint, Michigan, United States, 48504
United States, Missouri
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Kansas City, Missouri, United States, 64111-5964
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Kansas City, Missouri, United States, 64111
United States, Nebraska
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Lincoln, Nebraska, United States, 68510
United States, Nevada
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Las Vegas, Nevada, United States, 89101
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Las Vegas, Nevada, United States, 89119
United States, New York
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Bronx, New York, United States, 10461
United States, North Carolina
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Ashville, North Carolina, United States, 28801
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Wilmington, North Carolina, United States, 28401
United States, Ohio
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Willoughby Hills, Ohio, United States, 44094
United States, Pennsylvania
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Bethlehem, Pennsylvania, United States, 18017
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Uniontown, Pennsylvania, United States, 15401
United States, South Carolina
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Bamberg, South Carolina, United States, 29003
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Columbia, South Carolina, United States, 29203
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Greenville, South Carolina, United States, 29605
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Orangeburg, South Carolina, United States, 29118
United States, Texas
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Austin, Texas, United States, 78751
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Houston, Texas, United States, 77024
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Houston, Texas, United States, 77054
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Houston, Texas, United States, 77004
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San Antonio, Texas, United States, 78229
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San Antonio, Texas, United States, 78215
United States, Virginia
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Fairfax, Virginia, United States, 22033
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Mechanicsville, Virginia, United States, 23116
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Norfolk, Virginia, United States, 23507
United States, Washington
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Bremerton, Washington, United States, 98310
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PortOrchard, Washington, United States, 98366
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Silverdale, Washington, United States, 98383
Australia, New South Wales
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Gosford, New South Wales, Australia, 2250
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Newcastle, New South Wales, Australia, 2305
Australia, Victoria
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Reservoir, Victoria, Australia, 3073
Canada, Alberta
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Calgary, Alberta, Canada, T2R 0X7
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Calgary, Alberta, Canada, T2N 2T9
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Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
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Brampton, Ontario, Canada, L6Z 4N5
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London, Ontario, Canada, N6A 5A5
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Oakville, Ontario, Canada, L6J 3M5
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Toronto, Ontario, Canada, M4N 3M5
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Toronto, Ontario, Canada, M4C 5T2
Canada, Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
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Montreal, Quebec, Canada, H4J 1C5
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Montreal, Quebec, Canada, H1T 2M4
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Montreal, Quebec, Canada, H3M 3E3
Canada, Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7M 2Z1
Denmark
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Aarhus C, Denmark, DK-8000
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Copenhagen Oe, Denmark, 2100
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Gentofte, Denmark, 2820
Hong Kong
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Hong Kong, Hong Kong
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Pokfulam, Hong Kong
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Quarry Bay, Hong Kong
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Shatin, Hong Kong, N.T. 0
India
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Hyderabad, Andhra Pradesh, India, 500096
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Ahmedabad, Gujarat, India, 380 013
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Ahmedabad, Gujarat, India, 380 007
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Mumbai, Maharashtra, India, 400102
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Mumbai, Maharashtra, India, 400016
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Pune, Maharashtra, India, 411 011
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Pune, Maharashtra, India, 411 004
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Pune, Maharashtra, India, 411 001
Korea, Republic of
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Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
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Seongnam-si, Korea, Republic of, 463-707
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Seoul, Korea, Republic of, 156-707
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Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 135-710
Malaysia
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Kota Bharu, Kelantan, Malaysia, 16150
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Kubang Kerian, Kelantan, Malaysia, 16150,
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Taiping, Perak, Malaysia, 34000
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George Town, Pulau Pinang, Malaysia, 10990
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Kota Kinabalu, Sabah, Malaysia, 88586
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Kajang, Selangor, Malaysia, 43000
Mexico
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Angeles del Pedregal Cp., D.f., Mexico, 10700
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Mexico, DF, Mexico, 06100
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Guadalajara, Jalisco, Mexico, 44600
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Tlalpan, Mexico City, Mexico, 14000
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San Luis Potosi, San Luis, Mexico, 78240
Poland
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Bielsko-Biala, Poland, 43-300
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Katowice, Poland, 40-027
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Lublin, Poland, 20-536
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Warsaw, Poland, 4749
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Warszawa, Poland, 02-256
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Wroclaw, Poland, 50-556
Serbia
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Belgrade, Serbia, 11000
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Belgrade, Serbia, 11 000
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Nis, Serbia, 18000
Slovakia
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Bratislava, Slovakia, 813 69
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Levice, Slovakia, 934 01
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Presov, Slovakia, 081 81
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Rimavska Sobota, Slovakia, 979 12
South Africa
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Benoni, Gauteng, South Africa, 1500
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Johannesburg, Gauteng, South Africa, 2193
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Pretoria, Gauteng, South Africa, 0204
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Durban, KwaZulu Natal, South Africa, 4091
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Bloemfontein, South Africa, 9301
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Cape Town, South Africa, 7925
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Durban, South Africa, 4001
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Houghton, Johannesburg, South Africa, 2198
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Parow, South Africa, 7500
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Pretoria, South Africa, 132
Sweden
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Goteborg, Sweden, 413 45
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Stockholm, Sweden, 111 57
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Uppsala, Sweden, 751 85
United Kingdom
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Doncaster, South Yorkshire, United Kingdom, DN2 5LT
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Coventry, United Kingdom, CV2 2DX
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Edinburgh, United Kingdom, EH16 4TJ
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London, United Kingdom, SE1 9RT
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London, United Kingdom, E1 1BB
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Sheffield, United Kingdom, S5 7AU
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01200394     History of Changes
Other Study ID Numbers: A7331011
Study First Received: September 10, 2010
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Diabetic nephropathy
chronic kidney disease
PF-00489791
phosphodiesterase
PDE5

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 02, 2014