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

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NCT01200394

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Study Location
Saadat Ansari Internal Medicine
Huntsville, Alabama, 35801, United States
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetic Nephropathies
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Diabetic NephropathiesA Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy
NCT01200394
  1. Huntsville, Alabama
  2. Huntsville, Alabama
  3. Glendale, Arizona
  4. Tempe, Arizona
  5. Tempe, Arizona
  6. Azusa, California
  7. Azusa, California
  8. Covina, California
  9. La Mesa, California
  10. Sacramento, California
  11. San Dimas, California
  12. Whittier, California
  13. Whittier, California
  14. Yuba, California
  15. Edgewater, Florida
  16. Hialeah, Florida
  17. Jupiter, Florida
  18. Summerfield, Florida
  19. Conyers, Georgia
  20. Macon, Georgia
  21. Meridian, Idaho
  22. Chicago, Illinois
  23. Evergreen Park, Illinois
  24. Evergreen Park, Illinois
  25. Peoria, Illinois
  26. Elwood, Indiana
  27. Wichita, Kansas
  28. Paducah, Kentucky
  29. Metairie, Louisiana
  30. Shreveport, Louisiana
  31. Rockville, Maryland
  32. Dearborn, Michigan
  33. Flint, Michigan
  34. Flint, Michigan
  35. Kansas City, Missouri
  36. Lincoln, Nebraska
  37. Lincoln, Nebraska
  38. Las Vegas, Nevada
  39. Las Vegas, Nevada
  40. Bronx, New York
  41. Asheville, North Carolina
  42. Wilmington, North Carolina
  43. Willoughby Hills, Ohio
  44. Bethlehem, Pennsylvania
  45. Uniontown, Pennsylvania
  46. Columbia, South Carolina
  47. Greenville, South Carolina
  48. Orangeburg, South Carolina
  49. Orangeburg, South Carolina
  50. Orangeburg, South Carolina
  51. Austin, Texas
  52. Austin, Texas
  53. Houston, Texas
  54. Houston, Texas
  55. Houston, Texas
  56. San Antonio, Texas
  57. San Antonio, Texas
  58. Fairfax, Virginia
  59. Mechanicsville, Virginia
  60. Norfolk, Virginia
  61. Bremerton, Washington
  62. Port Orchard, Washington
  63. Silverdale, Washington
  64. Gosford, New South Wales
  65. Newcastle, New South Wales
  66. New Lambton, Newcastle
  67. New Lambton, Newcastle
  68. Reservoir, Victoria
  69. Calgary, Alberta
  70. Edmonton, Alberta
  71. Brampton, Ontario
  72. Brampton, Ontario
  73. London, Ontario
  74. Oakville, Ontario
  75. Toronto, Ontario
  76. Toronto, Ontario
  77. Greenfield Park, Quebec
  78. Montreal, Quebec
  79. Montreal, Quebec
  80. Saskatoon, Saskatchewan
  81. Saskatoon, Saskatchewan
  82. Saskatoon, Saskatchewan
  83. Aarhus,
  84. Copenhagen Oe,
  85. Gentofte,
  86. Hong Kong,
  87. Pokfulam,
  88. Pokfulam,
  89. Quarry Bay,
  90. Shatin,
  91. Hyderabad, Andhra Pradesh
  92. Ahmedabad, Gujarat
  93. Ahmedabad, Gujarat
  94. Mumbai, Maharashtra
  95. Mumbai, Maharashtra
  96. Pune, Maharashtra
  97. Pune, Maharashtra
  98. Pune, Maharashtra
  99. Pune, Maharashtra
  100. Pune, Maharashtra
  101. Seongnam-si, Gyeonggi-do
  102. Seongnam-si, Gyeonggi-do
  103. Seongnam-si,
  104. Seoul,
  105. Seoul,
  106. Seoul,
  107. Seoul,
  108. Seoul,
  109. Seoul,
  110. Kota Bharu, Kelantan
  111. Kubang Kerian, Kelantan
  112. Taiping, Perak
  113. George Town, Pulau Pinang
  114. George Town, Pulau Pinang
  115. Kota Kinabalu, Sabah
  116. Kajang, Selangor
  117. Mexico, DF
  118. Guadalajara, Jalisco
  119. Tlalpan, Mexico CITY
  120. San Luis Potosi, San Luis
  121. Angeles Del Pedregal Cp.,
  122. Bielsko-Biala,
  123. Katowice,
  124. Lublin,
  125. Warsaw,
  126. Warszawa,
  127. Warszawa,
  128. Warszawa,
  129. Warszawa,
  130. Wroclaw,
  131. Belgrade,
  132. Belgrade,
  133. Belgrade,
  134. Belgrade,
  135. Belgrade,
  136. Nis,
  137. Bratislava,
  138. Levice,
  139. Presov,
  140. Rimavska Sobota,
  141. Johannesburg, Gauteng- South Africa
  142. Benoni, Gauteng
  143. Pretoria, Gauteng
  144. Durban, Kwazulu Natal
  145. Bloemfontein,
  146. Cape Town,
  147. Durban,
  148. Durban,
  149. Houghton, Johannesburg,
  150. Parow,
  151. Pretoria,
  152. Goteborg,
  153. Stockholm,
  154. Uppsala,
  155. Doncaster, South Yorkshire
  156. Coventry,
  157. Edinburgh,
  158. London,
  159. London,
  160. Sheffield,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Nephropathies
Intervention  ICMJE
  • Drug: PF-00489791
    Tablet, 20 mg once daily for 12 weeks
  • Drug: Placebo
    Tablet, placebo once daily for 12 weeks
Study Arms  ICMJE
  • Experimental: PF-00489791
    Intervention: Drug: PF-00489791
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2014)		256
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2010)		230
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Denmark,   Hong Kong,   India,   Korea, Republic of,   Malaysia,   Mexico,   Poland,   Serbia,   Slovakia,   South Africa,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01200394
Other Study ID Numbers  ICMJE A7331011
2010-021358-20 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP