NCT01488877

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetic Nephropathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2011-12-08
• Last updated: 2013-10-29
• Results posted: 2013-09-23

Locations

6 sites across 1 country: United States