The Effect of Rosuvastatin on Adenosine Metabolism

• ClinicalTrials.gov Identifier: NCT00554138
• Recruitment Status: Completed
• First Posted: November 6, 2007
• Last Update Posted: September 23, 2008
• Sponsor: Radboud University
• Information provided by: Radboud University

Tracking Information

• First Submitted Date: November 5, 2007
• First Posted Date: November 6, 2007
• Last Update Posted Date: September 23, 2008
• Study Start Date: November 2007
• Actual Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 5, 2007): forearm vasodilatory response to dipyridamole [ Time Frame: 7 days ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00554138 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: November 5, 2007): lipid profile [ Time Frame: 7-10 days ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Rosuvastatin on Adenosine Metabolism
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Basic Science
• Condition: Adenosine Metabolism

Intervention

• Drug: placebo
  1 dd for 7-10 days
• Drug: rosuvastatin
  1 dd 20 mg for 7-10 days

Study Arms

• 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.

Recruitment Information

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

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT00554138
• Other Study ID Numbers: Rosudip01
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: G.A. Rongen, Radboud University Nijmegen Medical Centre
• Study Sponsor: Radboud University
• Collaborators: Not Provided

Investigators

• Study Director: Gerard Rongen, MD, PhD; Radboud University Medical Centre Dep. Pharmacology-Toxicology

• PRS Account: Radboud University
• Verification Date: September 2008