Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00652418
Other study ID # 91396
Secondary ID 308612
Status Completed
Phase Phase 2
First received April 1, 2008
Last updated October 10, 2013
Start date July 2004
Est. completion date October 2004

Study information

Verified date October 2013
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date October 2004
Est. primary completion date October 2004
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Drug:
Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)
Magnevist at a dose of 0.1 mmol/kg
Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)
Magnevist at a dose of 0.2 mmol/kg

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic ability MRI image in blinded read No
Secondary Visibility MRI image in blinded read No
Secondary Diagnostic confidence MRI image in blinded read No
See also
  Status Clinical Trial Phase
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Completed NCT00536796 - Percentage of Secondary Prevention Patients Treated to Their LDL-C Targets N/A
Completed NCT00371371 - Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI) Phase 1/Phase 2
Recruiting NCT00173602 - The Burden of Peripheral Artery Occlusion Disease and Associated Factors in Peritoneal Dialysis Patients N/A
Completed NCT00228384 - GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study Phase 4
Completed NCT00163267 - Mirror Trial - Follow-Up Management of Peripheral Arterial Intervention With Clopidogrel Phase 2/Phase 3
Completed NCT00106327 - Improving Functioning in Peripheral Arterial Disease N/A
Completed NCT00049907 - Cardiac and Renal Disease Study (CARDS) N/A
Completed NCT00000614 - Prevention of Recurrent Venous Thromboembolism (PREVENT) Phase 3
Completed NCT00005392 - Epidemiology of Venous Disease N/A
Recruiting NCT05596760 - Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers N/A
Recruiting NCT00539266 - Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia Phase 2/Phase 3
Completed NCT00541307 - GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER) N/A
Completed NCT00520312 - Magnetic Resonance Imaging to Identify Characteristics of Plaque Build-Up in People With Peripheral Arterial Disease N/A
Terminated NCT00504088 - Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia Phase 4
Completed NCT00533104 - Cell Therapy in Chronic Limb Ischemia Phase 1/Phase 2
Enrolling by invitation NCT05459818 - Individual Patient Data Analysis of Viabahn for Peripheral Arterial Disease
Completed NCT03875846 - Intraoperative Simultaneous Pressure Guided Revascularization Study
Active, not recruiting NCT05110677 - Pilot Study of Topographic Imaging of the Calf Muscle in Patients With PAD Using 3D Reconstruction of MSOT Images
Active, not recruiting NCT02856230 - An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK) Phase 2/Phase 3