NCT00154024

Brief Summary

Vascular responses to angiotensin II and histamine are compared before and after 30 days of systemic treatment with either irbesartan 150 mg or atorvastatin 20 mg.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Mar 2003

Longer than P75 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

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

September 28, 2006

Status Verified

July 1, 2006

First QC Date

September 8, 2005

Last Update Submit

September 27, 2006

Conditions

Healthy Subjects

Keywords

venoconstrictionvenodilationpleiotropic effects

Outcome Measures

Primary Outcomes (1)

  • vascular responses after treatment.

Interventions

atorvastatinDRUG
irbesartanDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subjects
  • no relevant disease
  • amendment: hypercholesterolaemic subjects

You may not qualify if:

  • any relevant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Clinical Pharmacology, Medical Faculty, University of Technology

Dresden, 01307, Germany

Location

Related Publications (1)

  • Schindler C, Guenther K, Hermann C, Ferrario CM, Schroeder C, Haufe S, Jordan J, Kirch W. Statin treatment in hypercholesterolemic men does not attenuate angiotensin II-induced venoconstriction. PLoS One. 2014 Sep 29;9(9):e103909. doi: 10.1371/journal.pone.0103909. eCollection 2014.

    PMID: 25264877DERIVED

MeSH Terms

Interventions

AtorvastatinIrbesartan

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSpiro CompoundsTetrazolesPolycyclic Compounds

Study Officials

  • Wilhelm Kirch, MD

    Institute of Clinical Pharmacology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

March 1, 2003

Study Completion

October 1, 2006

Last Updated

September 28, 2006

Record last verified: 2006-07

Locations

DE(1)