Trials / Completed
CompletedNCT00652418
Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography
Evaluation of a Single Intravenous Injection of Magnevist (SH L 451 A) at 0.1 mmol/kg and 0.2 mmol/kg in Contrast-enhanced 3D-Magnetic Resonance Angiography in Patients With Arterial Disease in the Abdominal to Leg Regions in the Ability of Detecting of Vessel Abnormalities
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A) | Magnevist at a dose of 0.1 mmol/kg |
| DRUG | Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A) | Magnevist at a dose of 0.2 mmol/kg |
Timeline
- Start date
- 2004-07-01
- Primary completion
- 2004-10-01
- Completion
- 2004-10-01
- First posted
- 2008-04-03
- Last updated
- 2013-10-14
Locations
3 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00652418. Inclusion in this directory is not an endorsement.