- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00229684
ARMOR (Analyzing Renal Mechanisms of Creatinine Excretion in Patients On tesaglitazaR)
August 29, 2011 updated by: AstraZeneca
A 24-week, Randomised, Parallel-Group, Multi-Centre, Open-Label Study of the Renal Effects of Tesaglitazar in Patients With Type 2 Diabetes Mellitus
This is a prospective 24-week, randomized, parallel-group, multi-center, active-controlled (pioglitazone 45 mg) open-label study designed to assess the effects of tesaglitazar 2 mg per day on components of renal excretion of creatinine in type 2 diabetics.
The study comprises a 2-week enrollment period, followed by a 24-week double blind treatment period and an 8-week follow-up period
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Pasadena, California, United States
- Research Site
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District of Columbia
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Washington, District of Columbia, United States
- Research Site
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Florida
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Gainesville, Florida, United States
- Research Site
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Miami, Florida, United States
- Research Site
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Orlando, Florida, United States
- Research Site
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Georgia
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Augusta, Georgia, United States
- Research Site
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Columbus, Georgia, United States
- Research Site
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Louisiana
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New Orleans, Louisiana, United States
- Research Site
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Nevada
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Reno, Nevada, United States
- Research Site
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New York
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Flushing, New York, United States
- Research Site
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North Carolina
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Durham, North Carolina, United States
- Research Site
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Ohio
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Cleveland, Ohio, United States
- Research Site
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Columbus, Ohio, United States
- Research Site
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Oklahoma
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Tulsa, Oklahoma, United States
- Research Site
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Pennsylvania
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Cheswick, Pennsylvania, United States
- Research Site
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Philadelphia, Pennsylvania, United States
- Research Site
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Tennessee
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Nashville, Tennessee, United States
- Research Site
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Texas
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Midland, Texas, United States
- Research Site
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San Antonio, Texas, United States
- Research Site
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Washington
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Gig Harbor, Washington, United States
- Research Site
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Seattle, Washington, United States
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provision of a written informed consent
- Men or women who are >=45 years of age
- Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
- Diagnosed with type 2 diabetes
- Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents
Exclusion Criteria:
- Type 1 diabetes
- New York Heart Association heart failure Class III or IV
- Treatment with chronic insulin
- History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
- History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
- Creatinine levels above twice the normal range
- Creatine kinase above 3 times the upper limit of normal
- Received any investigational product in other clinical studies within 12 weeks
- Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Effects of on tubular secretion of creatinine in type 2 diabetics after 12 weeks of treatment as assessed through determinations of:
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Glomerular filtration rate (GFR) by iothalamate clearance
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Endogenous creatinine clearance
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Secondary Outcome Measures
Outcome Measure |
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Endogenous creatinine clearance
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Effects of on tubular secretion of creatinine in type 2 diabetics after 24 weeks of treatment as assessed through determinations of:
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GFR by iothalamate clearance
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The time course of change in serum creatinine concentration and GFR during a 24-week period of tesaglitazar treatment in type 2 diabetics
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The effects of tesaglitazar on urinary protein excretion in type 2 diabetics by comparisons of urinary total protein and albumin excretion rates
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The effects of tesaglitazar on urinary creatinine excretion in type 2 diabetics by comparisons of urinary total creatinine excretion rates
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The pharmacokinetics of tesaglitazar during 24 weeks of therapy in type 2 diabetics.
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The safety and tolerability of tesaglitazar in type 2 diabetics by assessments of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, body weight, and physical examination.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Galida Medical Science Director, MD, AstraZeneca
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Primary Completion (Actual)
June 1, 2006
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
September 28, 2005
First Submitted That Met QC Criteria
September 28, 2005
First Posted (Estimate)
September 30, 2005
Study Record Updates
Last Update Posted (Estimate)
August 30, 2011
Last Update Submitted That Met QC Criteria
August 29, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D6160C00040
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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