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

September 10, 2010
May 19, 2014
October 2010
July 2013   (final data collection date for primary outcome measure)
Urine albumin: creatinine ratio (UACR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Urine albumin:creatinine ratio (UACR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01200394 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 highly sensitive 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 ]
Not Provided
Not Provided
 
A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetic Nephropathies
  • Drug: PF-00489791
    Tablet, 20 mg once daily for 12 weeks
  • Drug: Placebo
    Tablet, placebo once daily for 12 weeks
  • Experimental: PF-00489791
    Intervention: Drug: PF-00489791
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
256
August 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of,   United States,   Australia,   Canada,   Denmark,   Hong Kong,   India,   United Kingdom,   Malaysia,   Mexico,   Poland,   Serbia,   Slovakia,   South Africa,   Sweden
 
NCT01200394
A7331011
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2014

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