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 is currently recruiting participants.
Verified August 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01200394
First received: September 10, 2010
Last updated: August 6, 2013
Last verified: August 2013
  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 ]

Estimated Enrollment: 230
Study Start Date: October 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200394

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site Terminated
Huntsville, Alabama, United States, 35805
Pfizer Investigational Site Terminated
Huntsville, Alabama, United States, 35801
United States, Arizona
Pfizer Investigational Site Completed
Glendale, Arizona, United States, 85306
Pfizer Investigational Site Completed
Phoenix, Arizona, United States, 85004
Pfizer Investigational Site Completed
Tempe, Arizona, United States, 85284
United States, California
Pfizer Investigational Site Completed
Covina, California, United States, 91723
Pfizer Investigational Site Completed
La Mesa, California, United States, 91942
Pfizer Investigational Site Terminated
Sacramento, California, United States, 95825
Pfizer Investigational Site Completed
San Dimas, California, United States, 91773
Pfizer Investigational Site Active, not recruiting
Whittier, California, United States, 90602
Pfizer Investigational Site Active, not recruiting
Yuba, California, United States, 95991
United States, Florida
Pfizer Investigational Site Terminated
Edgewater, Florida, United States, 32132
Pfizer Investigational Site Completed
Hialeah, Florida, United States, 33012
Pfizer Investigational Site Active, not recruiting
Jupiter, Florida, United States, 33458
Pfizer Investigational Site Active, not recruiting
Summerfield, Florida, United States, 34491
United States, Georgia
Pfizer Investigational Site Terminated
Conyers, Georgia, United States, 30094
Pfizer Investigational Site Recruiting
Macon, Georgia, United States, 31217
United States, Idaho
Pfizer Investigational Site Terminated
Meridian, Idaho, United States, 83642
United States, Illinois
Pfizer Investigational Site Active, not recruiting
Chicago, Illinois, United States, 60616
Pfizer Investigational Site Completed
Evergreen Park, Illinois, United States, 60805
Pfizer Investigational Site Active, not recruiting
Peoria, Illinois, United States, 61603
United States, Indiana
Pfizer Investigational Site Active, not recruiting
Elwood, Indiana, United States, 46036
United States, Kansas
Pfizer Investigational Site Terminated
Wichita, Kansas, United States, 67214
United States, Kentucky
Pfizer Investigational Site Active, not recruiting
Paducah, Kentucky, United States, 42003
United States, Louisiana
Pfizer Investigational Site Active, not recruiting
Metairie, Louisiana, United States, 70006
Pfizer Investigational Site Completed
Shreveport, Louisiana, United States, 71101
United States, Maryland
Pfizer Investigational Site Completed
Rockville, Maryland, United States, 20852
United States, Michigan
Pfizer Investigational Site Terminated
Dearborn, Michigan, United States, 48124
Pfizer Investigational Site Completed
Flint, Michigan, United States, 48504
United States, Missouri
Pfizer Investigational Site Completed
Kansas City, Missouri, United States, 64111
United States, Nebraska
Pfizer Investigational Site Completed
Lincoln, Nebraska, United States, 68510
United States, Nevada
Pfizer Investigational Site Terminated
Las Vegas, Nevada, United States, 89101
Pfizer Investigational Site Terminated
Las Vegas, Nevada, United States, 89119
Pfizer Investigational Site Not yet recruiting
Reno, Nevada, United States, 89511
United States, New York
Pfizer Investigational Site Completed
Bronx, New York, United States, 10461
United States, North Carolina
Pfizer Investigational Site Completed
Ashville, North Carolina, United States, 28801
Pfizer Investigational Site Terminated
Wilmington, North Carolina, United States, 28401
United States, Ohio
Pfizer Investigational Site Completed
Willoughby Hills, Ohio, United States, 44094
United States, Pennsylvania
Pfizer Investigational Site Completed
Bethlehem, Pennsylvania, United States, 18017
Pfizer Investigational Site Active, not recruiting
Uniontown, Pennsylvania, United States, 15401
United States, South Carolina
Pfizer Investigational Site Terminated
Bamberg, South Carolina, United States, 29003
Pfizer Investigational Site Completed
Columbia, South Carolina, United States, 29203
Pfizer Investigational Site Completed
Greenville, South Carolina, United States, 29605
Pfizer Investigational Site Terminated
Orangeburg, South Carolina, United States, 29118
Pfizer Investigational Site Recruiting
Orangeburg, South Carolina, United States, 29118
United States, Texas
Pfizer Investigational Site Terminated
Austin, Texas, United States, 78751
Pfizer Investigational Site Terminated
Houston, Texas, United States, 77054
Pfizer Investigational Site Terminated
Houston, Texas, United States, 77024
Pfizer Investigational Site Completed
Houston, Texas, United States, 77004
Pfizer Investigational Site Completed
San Antonio, Texas, United States, 78229
Pfizer Investigational Site Completed
San Antonio, Texas, United States, 78215
United States, Virginia
Pfizer Investigational Site Active, not recruiting
Fairfax, Virginia, United States, 22033
Pfizer Investigational Site Active, not recruiting
Mechanicsville, Virginia, United States, 23116
Pfizer Investigational Site Active, not recruiting
Norfolk, Virginia, United States, 23507
Pfizer Investigational Site Active, not recruiting
Richmond, Virginia, United States, 23229
Pfizer Investigational Site Active, not recruiting
Richmond, Virginia, United States, 23226
United States, Washington
Pfizer Investigational Site Completed
Silverdale, Washington, United States, 98383
Australia, New South Wales
Pfizer Investigational Site Recruiting
Camperdown, New South Wales, Australia, 2050
Pfizer Investigational Site Recruiting
Gosford, New South Wales, Australia, 2250
Pfizer Investigational Site Recruiting
New Castle, New South Wales, Australia, 2305
Australia, Victoria
Pfizer Investigational Site Recruiting
Reservoir, Victoria, Australia, 3073
Pfizer Investigational Site Not yet recruiting
Richmond, Victoria, Australia, 3121
Canada, Alberta
Pfizer Investigational Site Completed
Calgary, Alberta, Canada, T2N 2T9
Pfizer Investigational Site Completed
Calgary, Alberta, Canada, T2R 0X7
Pfizer Investigational Site Terminated
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Pfizer Investigational Site Completed
Brampton, Ontario, Canada, L6Z 4N5
Pfizer Investigational Site Recruiting
London, Ontario, Canada, N6A 5A5
Pfizer Investigational Site Completed
Oakville, Ontario, Canada, L6J 3M5
Pfizer Investigational Site Completed
Toronto, Ontario, Canada, M4N 3M5
Pfizer Investigational Site Completed
Toronto, Ontario, Canada, M4C 5T2
Canada, Quebec
Pfizer Investigational Site Active, not recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Pfizer Investigational Site Completed
Montreal, Quebec, Canada, H4J 1C5
Pfizer Investigational Site Completed
Montreal, Quebec, Canada, H1T 2M4
Pfizer Investigational Site Completed
Montreal, Quebec, Canada, H3M 3E3
Canada, Saskatchewan
Pfizer Investigational Site Completed
Saskatoon, Saskatchewan, Canada, S7M 0Z9
Denmark
Pfizer Investigational Site Terminated
Aarhus C, Denmark, DK-8000
Pfizer Investigational Site Terminated
Gentofte, Denmark, DK-2820
Pfizer Investigational Site Terminated
Koebenhavn OE, Denmark, DK-2100
Hong Kong
Pfizer Investigational Site Recruiting
Hong Kong, Hong Kong
Pfizer Investigational Site Recruiting
Shatin, Hong Kong, N.T. 0
India
Pfizer Investigational Site Recruiting
Hyderabad, Andhra Pradesh, India, 500096
Pfizer Investigational Site Terminated
Ahmedabad, Gujarat, India, 380 013
Pfizer Investigational Site Terminated
Ahmedabad, Gujarat, India, 380 007
Pfizer Investigational Site Not yet recruiting
Bangalore, Karnataka, India, 560 017
Pfizer Investigational Site Recruiting
Mumbai, Maharashtra, India, 400016
Pfizer Investigational Site Recruiting
Pune, Maharashtra, India, 411 004
Pfizer Investigational Site Recruiting
Pune, Maharashtra, India, 411 011
Pfizer Investigational Site Terminated
Pune, Maharashtra, India, 411 001
Korea, Republic of
Pfizer Investigational Site Terminated
Gyeonggi-do, Korea, Republic of, 463-707
Pfizer Investigational Site Terminated
Seoul, Korea, Republic of, 135-710
Pfizer Investigational Site Terminated
Seoul, Korea, Republic of, 156-707
Pfizer Investigational Site Terminated
Seoul, Korea, Republic of, 110-744
Malaysia
Pfizer Investigational Site Recruiting
Kota Bahru, Kelantan, Malaysia, 16150
Pfizer Investigational Site Recruiting
Taiping, Perak, Malaysia, 34000
Pfizer Investigational Site Recruiting
George Town, Pulau Pinang, Malaysia, 10990
Pfizer Investigational Site Terminated
Kota Kinabalu, Sabah, Malaysia, 88586
Pfizer Investigational Site Terminated
Kajang, Selangor, Malaysia, 43000
Mexico
Pfizer Investigational Site Completed
Mexico, DF, Mexico, 06100
Pfizer Investigational Site Completed
Mexico, DF, Mexico, 10700
Pfizer Investigational Site Active, not recruiting
Guadalajara, Jalisco, Mexico, 44600
Pfizer Investigational Site Completed
Tlalpan, Mexico City, Mexico, 14000
Pfizer Investigational Site Recruiting
San Luis Potosi, Mexico, 78240
Poland
Pfizer Investigational Site Terminated
Bielsko-Biala, Poland, 43-300
Pfizer Investigational Site Completed
Katowice, Poland, 40-027
Pfizer Investigational Site Recruiting
Lublin, Poland, 20-536
Pfizer Investigational Site Terminated
Warszawa, Poland, 02-256
Pfizer Investigational Site Recruiting
Warszawa, Poland, 04-749
Pfizer Investigational Site Terminated
Wroclaw, Poland, 50-556
Serbia
Pfizer Investigational Site Recruiting
Belgrade, Serbia, 11 000
Pfizer Investigational Site Recruiting
Belgrade, Serbia, 11000
Pfizer Investigational Site Completed
Belgrade, Serbia, 11000
Pfizer Investigational Site Completed
Nis, Serbia, 18000
Slovakia
Pfizer Investigational Site Terminated
Levice, Slovakia, 934 01
Pfizer Investigational Site Terminated
Pezinok, Slovakia, 902 01
Pfizer Investigational Site Terminated
Presov, Slovakia, 081 81
Pfizer Investigational Site Terminated
Rimavska Sobota, Slovakia, 979 12
South Africa
Pfizer Investigational Site Terminated
Benoni, Gauteng, South Africa, 1500
Pfizer Investigational Site Terminated
Ga-Rankuwa Pretoria, Gauteng, South Africa, 0204
Pfizer Investigational Site Terminated
Johannesburg, Gauteng, South Africa, 2193
Pfizer Investigational Site Recruiting
Pretoria, Gauteng, South Africa, 0083
Pfizer Investigational Site Recruiting
Durban, Kwa-Zulu Natal, South Africa, 4001
Pfizer Investigational Site Terminated
Durban, KwaZulu Natal, South Africa, 4091
Pfizer Investigational Site Terminated
Parow, Western Cape, South Africa, 7500
Pfizer Investigational Site Completed
Bloemfontein, South Africa, 9301
Pfizer Investigational Site Terminated
Cape Town, South Africa, 7925
Pfizer Investigational Site Recruiting
Houghton, Johannesburg, South Africa, 2198
Sweden
Pfizer Investigational Site Terminated
Goteborg, Sweden, 413 45
Pfizer Investigational Site Completed
Stockholm, Sweden, 111 57
Pfizer Investigational Site Terminated
Uppsala, Sweden, 751 85
United Kingdom
Pfizer Investigational Site Terminated
Doncaster, South Yorkshire, United Kingdom, DN2 5LT
Pfizer Investigational Site Completed
Coventry, United Kingdom, CV2 2DX
Pfizer Investigational Site Completed
Edinburgh, United Kingdom, EH4 2XU
Pfizer Investigational Site Terminated
London, United Kingdom, E1 1BB
Pfizer Investigational Site Completed
London, United Kingdom, SE1 9RT
Pfizer Investigational Site Completed
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: August 6, 2013
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
Diabetic Nephropathies
Kidney Diseases
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 April 15, 2014