NCT00154011

Brief Summary

The study is designed to test the hypothesis in healthy subjects that the oral antidiabetic drug rosiglitazone provides additional vascular relaxing or modulating effects in addition to its blood glucose level reducing ability.

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 Sep 2005

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

September 1, 2005

Completed
7 days 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
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

September 12, 2006

Status Verified

September 1, 2006

First QC Date

September 8, 2005

Last Update Submit

September 11, 2006

Conditions

Healthy Subjects

Keywords

vascular reactivity, venodilation

Outcome Measures

Primary Outcomes (1)

  • Vascular reactivity after 8 weeks treatment.

Secondary Outcomes (1)

  • Changes in angiotensin peptide metabolism.

Interventions

rosiglitazone (drug)DRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Healthy
  • years old
  • Non-smoker
  • No additional medication

You may not qualify if:

  • Any relevant disease
  • Smokers
  • Elevated liver enzymes
  • Body weight different from Broca norm \> 20%
  • Allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Clinical Pharmacology

Dresden, 01307, Germany

Location

MeSH Terms

Interventions

RosiglitazonePharmaceutical Preparations

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic 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
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

September 1, 2005

Study Completion

June 1, 2006

Last Updated

September 12, 2006

Record last verified: 2006-09

Locations

DE(1)