- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00554138
The Effect of Rosuvastatin on Adenosine Metabolism
September 22, 2008 updated by: Radboud University Medical Center
Rosuvastatin Augments Dipyridamole Induced Vasodilation by Increased Adenosine Receptor Stimulation.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nijmegen, Netherlands, 6500 HB
- Radboud University Nijmegen Medical Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 2
|
1 dd 20 mg for 7-10 days
|
Placebo Comparator: 1
|
1 dd for 7-10 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
forearm vasodilatory response to dipyridamole
Time Frame: 7 days
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
lipid profile
Time Frame: 7-10 days
|
7-10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Gerard Rongen, MD, PhD, Radboud University Medical Centre Dep. Pharmacology-Toxicology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
November 5, 2007
First Submitted That Met QC Criteria
November 5, 2007
First Posted (Estimate)
November 6, 2007
Study Record Updates
Last Update Posted (Estimate)
September 23, 2008
Last Update Submitted That Met QC Criteria
September 22, 2008
Last Verified
September 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rosudip01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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