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Trial record 49 of 1197 for:    Adenosine

The Effect of Rosuvastatin on Adenosine Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00554138
Recruitment Status : Completed
First Posted : November 6, 2007
Last Update Posted : September 23, 2008
Sponsor:
Information provided by:
Radboud University

Tracking Information
First Submitted Date  ICMJE November 5, 2007
First Posted Date  ICMJE November 6, 2007
Last Update Posted Date September 23, 2008
Study Start Date  ICMJE November 2007
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2007)
forearm vasodilatory response to dipyridamole [ Time Frame: 7 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00554138 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2007)
lipid profile [ Time Frame: 7-10 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Rosuvastatin on Adenosine Metabolism
Official Title  ICMJE Rosuvastatin Augments Dipyridamole Induced Vasodilation by Increased Adenosine Receptor Stimulation.
Brief Summary The aim of this study is to show whether rosuvastatin influences adenosine metabolism. Therefore we will determine whether rosuvasatin increases dipyridamole-induced vasodilation by increased adenosine receptor stimulation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Adenosine Metabolism
Intervention  ICMJE
  • Drug: placebo
    1 dd for 7-10 days
  • Drug: rosuvastatin
    1 dd 20 mg for 7-10 days
Study Arms  ICMJE
  • Placebo Comparator: 1
    Intervention: Drug: placebo
  • Experimental: 2
    Intervention: Drug: rosuvastatin
Publications * Meijer P, Oyen WJ, Dekker D, van den Broek PH, Wouters CW, Boerman OC, Scheffer GJ, Smits P, Rongen GA. Rosuvastatin increases extracellular adenosine formation in humans in vivo: a new perspective on cardiovascular protection. Arterioscler Thromb Vasc Biol. 2009 Jun;29(6):963-8. doi: 10.1161/ATVBAHA.108.179622. Epub 2009 Apr 9.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2007)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age 18 - 50 years
  • Signed informed consent

Exclusion Criteria:

  • hypertension
  • hypercholesterolemia
  • diabetes Mellitus
  • alanine aminotransferase > 90 U/L
  • creatinine Kinase > 440 U/L
  • cardiovascular disease
  • GFR < 80 ml/min
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00554138
Other Study ID Numbers  ICMJE Rosudip01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party G.A. Rongen, Radboud University Nijmegen Medical Centre
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gerard Rongen, MD, PhD Radboud University Medical Centre Dep. Pharmacology-Toxicology
PRS Account Radboud University
Verification Date September 2008

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