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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01488877
First received: December 6, 2011
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetic Nephropathy
 Drug: PF-03882845
Drug: Spironolactone
Other: placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety-related parameters including electrocardiograph change from baseline [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pharmacokinetic parameters of PF-03882845: AUCτ, Tmax, Cmax on Day 1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • pharmacokinetic parameters of PF-03882845: AUCτ(ss), Tmax, Cmax(ss), Cmin(ss), Cavg(ss), CL/F, Vz/F and Rac on Day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Change from baseline in blood pressure and heart rate. [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: January 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF03882845 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
Active Comparator: Spironolactone
25 mg once daily
 Drug: Spironolactone
spironolactone 25 mg once daily
Placebo Comparator: Placebo
Placebo once daily
 Other: placebo
placebo once daily

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488877

Locations
United States, California
Pfizer Investigational Site
Chula Vista, California, United States, 91911
Pfizer Investigational Site
San Diego, California, United States, 92123
United States, Florida
Pfizer Investigational Site
DeLand, Florida, United States, 32720
Pfizer Investigational Site
Miami, Florida, United States, 33169
United States, Michigan
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49007
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10019
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01488877     History of Changes
Other Study ID Numbers: B0171011
Study First Received: December 6, 2011
Last Updated: December 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Type 2 diabetes mellitus. albuminuria.

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Spironolactone
 Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013