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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetic Nephropathy

Intervention: PF-03882845 (Drug); PF-03882845 (Drug); PF-03882845 (Drug); Spironolactone (Drug); placebo (Other)

Phase: Phase 1

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

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

Primary outcome:

Change From Baseline in Serum Potassium at Day 8

Change From Baseline in Serum Potassium at Day 15

Number of Participants With Confirmed and Severe Hyperkalemia

Secondary outcome:

Plasma Pharmacokinetic (PK) Parameters

Change From Baseline in Sitting Systolic and Diastolic Blood Pressure at Day 15

Change From Baseline in Sitting Pulse Rate at Day 15

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Pfizer Investigational Site, Chula Vista, California 91911, United States

Pfizer Investigational Site, San Diego, California 92123, United States

Pfizer Investigational Site, DeLand, Florida 32720, United States

Pfizer Investigational Site, Miami, Florida 33169, United States

Pfizer Investigational Site, Kalamazoo, Michigan 49007, United States

Pfizer Investigational Site, New York, New York 10019, United States

Additional Information

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

Starting date: January 2012
Last updated: September 24, 2013

Page last updated: August 23, 2015

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