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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-07-31

Brief Summary

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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.

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Detailed Description

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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

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Type 2 Diabetic Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF03882845

Group Type EXPERIMENTAL

PF-03882845

Intervention Type DRUG

3 mg tablet once daily

PF-03882845

Intervention Type DRUG

up to 10 mg tablet once daily

PF-03882845

Intervention Type DRUG

up to 30 mg once daily

Spironolactone

25 mg once daily

Group Type ACTIVE_COMPARATOR

Spironolactone

Intervention Type DRUG

spironolactone 25 mg once daily

Placebo

Placebo once daily

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo once daily

Interventions

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PF-03882845

3 mg tablet once daily

Intervention Type DRUG

PF-03882845

up to 10 mg tablet once daily

Intervention Type DRUG

PF-03882845

up to 30 mg once daily

Intervention Type DRUG

Spironolactone

spironolactone 25 mg once daily

Intervention Type DRUG

placebo

placebo once daily

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No