NCT00415805

Brief Summary

This is an explorative small pilot study comparing two MRA contrast agents, one of which has been on the market for a few years and the other fairly new to the market. Since the study is explorative and designed to provide preliminary information for consideration for a future larger study, sample size is not based on statistical assumptions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2006

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

December 1, 2006

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 25, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

August 1, 2023

Status Verified

March 1, 2009

Enrollment Period

2 years

First QC Date

December 22, 2006

Last Update Submit

July 31, 2023

Conditions

Steno-occlusive Disease

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity compared to DSA

    post dose

Secondary Outcomes (1)

  • accuracy and predictive values; inter-reader agreement for diagnostic performance

    post dose

Study Arms (2)

1

EXPERIMENTAL
Drug: Multihance

2

ACTIVE COMPARATOR
Drug: vasovist

Interventions

MultihanceDRUG

0.5 Molar, single injection at 0.2 mL/kg

1
vasovistDRUG

0.25 molar single injection 0.03 ml/kg

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Known or suspected renovascular disease based on one of the following criteria:
  • severe hypertension
  • hypertension refractory to standard therapy
  • abrupt onset of moderate to severe hypertension at age \< 35 years
  • normalized blood pressure by an ACE inhibitor in a patient with moderate or severe hypertension
  • unexplained by stable elevation of serum creatinine \> 2Mg/dL
  • positive findings for stenosis from another imaging modality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bracco Imaging, S.p.A

Milan, 20134, Italy

Location

MeSH Terms

Interventions

gadobenic acidgadofosveset trisodium

Study Officials

  • Gianpaolo Pirovano, MD

    Bracco Diagnostics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2006

First Posted

December 25, 2006

Study Start

December 1, 2006

Primary Completion

December 1, 2008

Study Completion

February 1, 2009

Last Updated

August 1, 2023

Record last verified: 2009-03

Locations

IT(1)