A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy

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NCT01488877

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Study Location
Pfizer Investigational Site
Chula Vista, California, 91911, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetic Nephropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Males and/or Females between 18-65 years, inclusive.

- Body mass index of 18.5 to 45.4 kg/m2 at screening, inclusive. body weight equals or greater than 110 lb.

- Have type 2 diabetes mellitus.

- On stable dose of anti-diabetic and anti-hypertensive medication prior to screening.

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


- Recent evidence or medical history of unstable concurrent disease.


- Cardiovascular event within 3 months prior to screening.


- History of renal transplant.


- History of hospitalization for acute kidney injury or acute kidney dialysis within 6
months prior to screening.

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Type 2 Diabetic NephropathyA Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy
NCT01488877
  1. Chula Vista, California
  2. San Diego, California
  3. DeLand, Florida
  4. Miami, Florida
  5. Kalamazoo, Michigan
  6. New York, New York
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy
Official Title  ICMJE A 2-week, Phase 1b, Randomized, Double-Blind, Placebo- Controlled, Multi-Dose, Dose-Escalating Study With PF-03882845 And One Dose Of Spironolactone To Evaluate Safety, Tolerability, Pharmacokinetics And Pharmacodynamics In Subjects With Type 2 Diabetes Mellitus And Albuminuria
Brief Summary PF-03882845 is a compound proposed for treatment of type 2 diabetic nephropathy. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-03882845 in this population.
Detailed Description This study was terminated on 12-Sep-2012; this decision was made due to poor recruitment and overall business strategy. The study was not terminated for safety reasons nor for lack of efficacy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Type 2 Diabetic Nephropathy
Intervention  ICMJE
  • Drug: PF-03882845
    3 mg tablet once daily
  • Drug: PF-03882845
    up to 10 mg tablet once daily
  • Drug: PF-03882845
    up to 30 mg once daily
  • Drug: Spironolactone
    spironolactone 25 mg once daily
  • Other: placebo
    placebo once daily
Study Arms  ICMJE
  • Experimental: PF03882845
    Interventions:
    • Drug: PF-03882845
    • Drug: PF-03882845
    • Drug: PF-03882845
  • Active Comparator: Spironolactone
    25 mg once daily
    Intervention: Drug: Spironolactone
  • Placebo Comparator: Placebo
    Placebo once daily
    Intervention: Other: 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 Terminated
Actual Enrollment  ICMJE
 (submitted: September 24, 2013)		6
Original Estimated Enrollment  ICMJE
 (submitted: December 6, 2011)		64
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and/or Females between 18-65 years, inclusive.
  • Body mass index of 18.5 to 45.4 kg/m2 at screening, inclusive. body weight equals or greater than 110 lb.
  • Have type 2 diabetes mellitus.
  • On stable dose of anti-diabetic and anti-hypertensive medication prior to screening.

Exclusion Criteria:

  • Recent evidence or medical history of unstable concurrent disease.
  • Cardiovascular event within 3 months prior to screening.
  • History of renal transplant.
  • History of hospitalization for acute kidney injury or acute kidney dialysis within 6 months prior to screening.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (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 United States
Removed Location Countries Belgium
 
Administrative Information
NCT Number  ICMJE NCT01488877
Other Study ID Numbers  ICMJE B0171011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 September 2013

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