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The Effect of Rosuvastatin on Adenosine Metabolism

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adenosine Metabolism Drug: placebo Drug: rosuvastatin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Rosuvastatin Augments Dipyridamole Induced Vasodilation by Increased Adenosine Receptor Stimulation.
Study Start Date : November 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : April 2008

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 1 Drug: placebo
1 dd for 7-10 days
Experimental: 2 Drug: rosuvastatin
1 dd 20 mg for 7-10 days


Outcome Measures
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Primary Outcome Measures :
  1. forearm vasodilatory response to dipyridamole [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. lipid profile [ Time Frame: 7-10 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554138


Locations
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Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
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Study Director: Gerard Rongen, MD, PhD Radboud University Medical Centre Dep. Pharmacology-Toxicology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: G.A. Rongen, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00554138     History of Changes
Other Study ID Numbers: Rosudip01
First Posted: November 6, 2007    Key Record Dates
Last Update Posted: September 23, 2008
Last Verified: September 2008
Keywords provided by Radboud University:
rosuvastatin
dipyridamole
caffeine
Additional relevant MeSH terms:
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Adenosine
Dipyridamole
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Phosphodiesterase Inhibitors
Platelet Aggregation Inhibitors