The Effect of Rosuvastatin on Adenosine Metabolism

• Sponsor: Radboud University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00554138
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Nov 1, 2007
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

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

Primary Outcome Measures

1. forearm vasodilatory response to dipyridamole [7 days]

Secondary Outcome Measures

1. lipid profile [7-10 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Radboud University Nijmegen Medical Centre	Nijmegen		Netherlands	6500 HB

Sponsors and Collaborators

• Radboud University Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00554138
• Other Study ID Numbers: Rosudip01
• First Posted: Nov 6, 2007
• Last Update Posted: Sep 23, 2008
• Last Verified: Sep 1, 2008

• Keywords provided by , ,: rosuvastatin; dipyridamole; caffeine
• Additional relevant MeSH terms: Rosuvastatin Calcium

Study Results

No Results Posted as of Sep 23, 2008