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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00554138
Other study ID # Rosudip01
Secondary ID
Status Completed
Phase N/A
First received November 5, 2007
Last updated September 22, 2008
Start date November 2007
Est. completion date April 2008

Study information

Verified date September 2008
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date April 2008
Est. primary completion date March 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Netherlands Radboud University Nijmegen Medical Centre Nijmegen

Sponsors (1)

Lead Sponsor Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary forearm vasodilatory response to dipyridamole 7 days
Secondary lipid profile 7-10 days