Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging

NCT00770679

Last updated date
Study Location
Harry SIlber, MD
Baltimore, Maryland, 21224, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetes
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-90 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age 40-90

- Male or female

- Type 2 diabetes

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Known pregnancy or nursing.


- Females of child bearing potential must have been surgically sterilized or be post
menopausal.


- Smoking


- Known vascular disease


- Inability to complete MRI scan


- Symptoms of claudication


- Use of a nitrate medicine


- Use of any cholesterol-lowering agent


- LDL < 70


- Acute illness


- Liver disease


- Contraindication to getting an MRI scan (i.e. electronic implant, shrapnel, cerebral
aneurysm clip, welding history).

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Advanced Information
Descriptive Information
Brief Title  ICMJE Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging
Official Title  ICMJE Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging
Brief Summary Cholesterol-lowering drugs called statins improve the functioning of the endothelium, and help prevent heart disease. The investigators are testing whether statins improve endothelial function more in the arteries that have worse endothelium to begin with. One of the functions of the endothelium is to help control how blood vessels dilate (expand) or contract (narrow) in different situations. This affects how blood flows through those vessels. Magnetic resonance imaging (MRI) can be used to evaluate endothelial function in the arms and legs noninvasively.
Detailed Description Correct
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Diabetes
Intervention  ICMJE Drug: lipitor
80 mg everyday (QD) for 3 weeks
Other Name: atorvastatin
Study Arms  ICMJE Experimental: High-Dose Statin
80 mg atorvastatin daily for 3 weeks
Intervention: Drug: lipitor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 14, 2017)
16
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2008)
24
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 40-90
  • Male or female
  • Type 2 diabetes

Exclusion Criteria:

  • Known pregnancy or nursing.
  • Females of child bearing potential must have been surgically sterilized or be post menopausal.
  • Smoking
  • Known vascular disease
  • Inability to complete MRI scan
  • Symptoms of claudication
  • Use of a nitrate medicine
  • Use of any cholesterol-lowering agent
  • LDL < 70
  • Acute illness
  • Liver disease
  • Contraindication to getting an MRI scan (i.e. electronic implant, shrapnel, cerebral aneurysm clip, welding history).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00770679
Other Study ID Numbers  ICMJE NA00002253
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Harry Silber, MDJHU
PRS Account Johns Hopkins University
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP