MedDataX Logo

Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography

NCT ID: NCT00652418

Last Updated: 2013-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2004-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of the study was to compare the efficacy of Magnevist (SH L 451 A) at doses of 0.1 mmol/kg and 0.2 mmol/kg in contrast-enhanced 3D-Magnetic Resonance Angiography in three regions (abdominal, femoral, and leg regions) for visualization of arteries, evaluating 179 not assessable: caused by contrast media in the evaluation of structural abnormalities. Magnevist (SH L 451 A) was administered intravenously in a crossover design in patients with arterial disease in the abdominal to leg regions. The safety of the 0.2 mmol/kg dose was also assessed.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Magnetic Resonance Angiography Peripheral Vascular Diseases Peripheral Arterial Diseases

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Magnevist Magnetic Resonance Angiography Meglumine gadopentetate Determination of effective dose in MRA

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Group Type ACTIVE_COMPARATOR

Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)

Intervention Type DRUG

Magnevist at a dose of 0.1 mmol/kg

Arm 2

Group Type EXPERIMENTAL

Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)

Intervention Type DRUG

Magnevist at a dose of 0.2 mmol/kg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)

Magnevist at a dose of 0.1 mmol/kg

Intervention Type DRUG

Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)

Magnevist at a dose of 0.2 mmol/kg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who are scheduled to undergo contrast-enhanced 3D-Magnetic Resonance Angiography

Exclusion Criteria

* Patients with an ankle brachial pressure index (ABPI) of 0.3 or less
* Patients with allergy to contrast media
* Patients with serious hepatic impairment
* Patients with serious renal impairment
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hirosaki-shi, Aomori, Japan

Site Status

Funai-gun, Kyoto, Japan

Site Status

Hamamatsu, Shizuoka, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

308612

Identifier Type: -

Identifier Source: secondary_id

91396

Identifier Type: -

Identifier Source: org_study_id