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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Chula Vista, California, 91911 United States
Contact
1-800-718-1021
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.

NCT01488877
Pfizer
Terminated
A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy

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A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy
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
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Type 2 Diabetic Nephropathy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
July 2012
July 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
Belgium
 
NCT01488877
B0171011
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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[email protected]



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