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: September 24, 2013
Last verified: September 2013

December 6, 2011
September 24, 2013
January 2012
July 2012   (final data collection date for primary outcome measure)
  • Change From Baseline in Serum Potassium at Day 8 [ Time Frame: Baseline, Day 7, 8 ] [ Designated as safety issue: Yes ]
    Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 8 value calculated was average of 0 hours (immediately pre-dose) measurements on Day 7 and 8. Change from baseline values were presented under time point of Day 8.
  • Change From Baseline in Serum Potassium at Day 15 [ Time Frame: Baseline, Day 14, 15 ] [ Designated as safety issue: Yes ]
    Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 15 value calculated was average of 0 hours (immediately pre-dose) measurement on Day 14 and measurement obtained prior to discharge on Day 15. Change from baseline values were presented under time point of Day 15.
  • Number of Participants With Confirmed and Severe Hyperkalemia [ Time Frame: Baseline up to Day 15 ] [ Designated as safety issue: Yes ]
    Hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated. Confirmed hyperkalemia is defined as serum potassium level greater than (>) upper limit of normal (ULN) of 5.4 mEq/L. Severe hyperkalemia is defined as serum potassium level >= 6.0 mEq/L. Number of participants with at least 1 confirmed or severe hyperkalemia is reported.
Safety-related parameters including electrocardiograph,vital signs, adverse events, and laboratory tests. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01488877 on ClinicalTrials.gov Archive Site
  • Plasma Pharmacokinetic (PK) Parameters [ Time Frame: 0 (pre-dose), 2, 4, 6, 8, 10, 14, 24 hours post-dose on Day 1, 14 ] [ Designated as safety issue: No ]
    PK parameters were to be evaluated at Day 1 and Day 14 (steady state). Maximum observed plasma concentration (Cmax), time to reach maximum observed plasma concentration (Tmax), area under the curve from time zero to end of dosing interval (AUCtau) were to be evaluated at both Day 1 and Day 14 (steady state). Minimum observed plasma trough concentration (Cmin), average plasma concentration (Cavg), apparent oral clearance (CL/F), apparent volume of distribution (Vz/F) were to be evaluated only at Day 14 (steady state). Observed accumulation ratio (Rac) was also planned to be analyzed.
  • Change From Baseline in Sitting Systolic and Diastolic Blood Pressure at Day 15 [ Time Frame: Day 1 (Baseline), 15 ] [ Designated as safety issue: Yes ]
    Systolic blood pressure (BP): BP when heart is contracting; maximum arterial pressure during contraction of left ventricle of heart. Diastolic blood pressure: BP when heart is relaxing; minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed; average of triplicate BP values collected pre-dose on Day 1 served as baseline. The same arm and same sized cuff (properly sized and calibrated) was used throughout the study, after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements.
  • Change From Baseline in Sitting Pulse Rate at Day 15 [ Time Frame: Day 1 (Baseline), 15 ] [ Designated as safety issue: Yes ]
    Sitting pulse rate was measured in the brachial/radial artery for at least 30 seconds. A total of 3 measurements were performed; average of triplicate pulse rate values collected pre-dose on Day 1 served as baseline.
  • pharmacokinetic parameters related to PF-03882845. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Change from baseline in blood pressure and heart rate. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01488877
B0171011
No
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