Phase 3
Completed N=83
Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients
Vascular Diseases
Source: ClinicalTrials.gov NCT00395733 ↗
Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcomePrimary: Number of Vessel Segments Visualized With Diagnostic Quality — 8.10; 8.33; 8.03; 8.33 vessel segments
Summary
The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Vessel Segments Visualized With Diagnostic Quality |
8.10; 8.33; 8.03; 8.33; 7.55; 7.88 | — |
| SECONDARY Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator |
63; 65; 0; 0; 0; 0 | — |
| SECONDARY Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1 |
61; 63; 0; 0; 1; 0 | — |
| SECONDARY Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2 |
56; 63; 3; 1; 1; 0 | — |
| SECONDARY Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3 |
59; 63; 0; 0; 2; 0 | — |
| SECONDARY MRA Diagnosis by Investigators |
6; 8; 494; 504; 47; 30 | — |
| SECONDARY MRA Diagnosis by Blinded Reader 1 |
5; 5; 503; 497; 33; 37 | — |
| SECONDARY MRA Diagnosis by Blinded Reader 2 |
15; 10; 503; 549; 83; 38 | — |
| SECONDARY MRA Diagnosis by Blinded Reader 3 |
3; 2; 489; 499; 8; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Chinese origin
- Known or suspected blood vessel diseases
Exclusion Criteria
- Pregnancy
- Lactation
- Conditions interfering with MRI
- Allergy to any contrast agent or any drugs
- Participation in other trial
- Require emergency treatment
- Severely impaired liver and kidney functions
Data sourced from ClinicalTrials.gov (NCT00395733). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.