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The Effect of Rosuvastatin on Adenosine Metabolism

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00554138
First received: November 5, 2007
Last updated: September 22, 2008
Last verified: September 2008
History of Changes
  Purpose

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 Intervention
Adenosine Metabolism
 Drug: placebo
Drug: rosuvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Rosuvastatin Augments Dipyridamole Induced Vasodilation by Increased Adenosine Receptor Stimulation.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Radboud University:

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

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

Enrollment: 24
Study Start Date: November 2007
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: placebo
1 dd for 7-10 days
Experimental: 2 Drug: rosuvastatin
1 dd 20 mg for 7-10 days

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554138

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Study Director: Gerard Rongen, MD, PhD Radboud University Medical Centre Dep. Pharmacology-Toxicology
  More Information

No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: G.A. Rongen, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00554138     History of Changes
Other Study ID Numbers: Rosudip01
Study First Received: November 5, 2007
Last Updated: September 22, 2008
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
rosuvastatin
dipyridamole
caffeine

Additional relevant MeSH terms:
Adenosine
Dipyridamole
Rosuvastatin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
 Vasodilator Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Hematologic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents

ClinicalTrials.gov processed this record on June 17, 2013