NCT00554138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

September 23, 2008

Status Verified

September 1, 2008

Enrollment Period

4 months

First QC Date

November 5, 2007

Last Update Submit

September 22, 2008

Conditions

Adenosine Metabolism

Keywords

rosuvastatindipyridamolecaffeine

Outcome Measures

Primary Outcomes (1)

  • forearm vasodilatory response to dipyridamole

    7 days

Secondary Outcomes (1)

  • lipid profile

    7-10 days

Study Arms (2)

1

PLACEBO COMPARATOR
Drug: placebo

2

EXPERIMENTAL
Drug: rosuvastatin

Interventions

placeboDRUG

1 dd for 7-10 days

1
rosuvastatinDRUG

1 dd 20 mg for 7-10 days

2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18 - 50 years
  • Signed informed consent

You may not qualify if:

  • hypertension
  • hypercholesterolemia
  • diabetes Mellitus
  • alanine aminotransferase \> 90 U/L
  • creatinine Kinase \> 440 U/L
  • cardiovascular disease
  • GFR \< 80 ml/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (1)

  • Meijer P, Oyen WJ, Dekker D, van den Broek PH, Wouters CW, Boerman OC, Scheffer GJ, Smits P, Rongen GA. Rosuvastatin increases extracellular adenosine formation in humans in vivo: a new perspective on cardiovascular protection. Arterioscler Thromb Vasc Biol. 2009 Jun;29(6):963-8. doi: 10.1161/ATVBAHA.108.179622. Epub 2009 Apr 9.

    PMID: 19359665DERIVED

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gerard Rongen, MD, PhD

    Radboud University Medical Centre Dep. Pharmacology-Toxicology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 5, 2007

First Posted

November 6, 2007

Study Start

November 1, 2007

Primary Completion

March 1, 2008

Study Completion

April 1, 2008

Last Updated

September 23, 2008

Record last verified: 2008-09

Locations

NL(1)