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

NCT ID: NCT01488877

Last Updated: 2013-10-29

Study Results

Results available

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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.

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

Keywords

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Type 2 diabetes mellitus. albuminuria.

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

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Chula Vista, California, United States

Site Status

Pfizer Investigational Site

San Diego, California, United States

Site Status

Pfizer Investigational Site

DeLand, Florida, United States

Site Status

Pfizer Investigational Site

Miami, Florida, United States

Site Status

Pfizer Investigational Site

Kalamazoo, Michigan, United States

Site Status

Pfizer Investigational Site

New York, New York, United States

Site Status

Countries

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Belgium United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0171011&StudyName=A%20Study%20To%20Evaluate%20The%20Safety%20And%20Tolerability%20Of%20PF-03882845%20In%20Patients%20With%20Type%202%20Diabetic%20Nephropathy

To obtain contact information for a study center near you, click here.

Other Identifiers

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B0171011

Identifier Type: -

Identifier Source: org_study_id