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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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ClinicalTrials.gov Identifier: NCT01200394
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathies Drug: PF-00489791 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Actual Study Start Date : December 2010
Primary Completion Date : July 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Urine albumin: creatinine ratio (UACR) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Urine albumin: creatinine ratio at 3, 6 and 16 weeks [ Time Frame: 16 weeks ]
  2. Urine protein: creatinine ratio at 3, 6, 12 and 16 weeks [ Time Frame: 16 weeks ]
  3. Estimated glomerular filtration rate at 3, 6, 12 and 16 weeks [ Time Frame: 16 weeks ]
  4. Systolic, diastolic and mean arterial blood pressure at 3, 6, 12 and 16 weeks [ Time Frame: 16 weeks ]
  5. Serum creatinine at 3, 6, 12 and 16 weeks [ Time Frame: 16 weeks ]
  6. Urinary TGFbeta1 at Weeks 3, 6, 12 and 16. [ Time Frame: 16 weeks ]
  7. Serum C-reactive protein (hs-CRP) at Weeks 12 and 16. [ Time Frame: 16 weeks ]
  8. Serum cystatin C at Weeks 12 and 16. [ Time Frame: 16 weeks ]
  9. An assessment of the pharmacokinetic parameters of PF-00489791. [ Time Frame: 16 weeks ]
  10. Plasma glycosylated hemoglobin (HbA1c). [ Time Frame: 16 weeks ]
  11. Safety and tolerability measures (AEs, clinical laboratory assessments, physical examination including weight, worsening of edema, increased use of diuretics). [ Time Frame: 16 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200394


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Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01200394     History of Changes
Other Study ID Numbers: A7331011
2010-021358-20 ( EudraCT Number )
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action