A Multiple Ascending Dose Study of RO4905417 in Healthy Volunteers and Patients With Peripheral Arterial Disease (PAD).
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ClinicalTrials.gov Identifier: NCT00760565 |
Recruitment Status
:
Completed
First Posted
: September 26, 2008
Last Update Posted
: November 2, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peripheral Arterial Disease (PAD) | Drug: RO4905417 Drug: placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Multiple-Ascending Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO4905417 Following Intravenous Infusion in Healthy Volunteers and Patients With Peripheral Arterial Disease |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | June 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: RO4905417
3mg/kg iv every 28 days for 3 infusions
|
Placebo Comparator: 10 |
Drug: placebo
20mg/kg iv every 28 days for 3 infusions
|
Experimental: 11 |
Drug: RO4905417
20mg/kg iv every 28 days for 3 infusions
|
Placebo Comparator: 12 |
Drug: placebo
20mg/kg iv every 28 days for 3 infusions
|
Placebo Comparator: 2 |
Drug: placebo
3mg/kg iv every 28 days for 3 infusions
|
Experimental: 3 |
Drug: RO4905417
3mg/kg iv every 28 days for 3 infusions
|
Placebo Comparator: 4 |
Drug: placebo
3mg/kg iv every 28 days for 3 infusions
|
Experimental: 5 |
Drug: RO4905417
7mg/kg iv every 28 days for 3 infusions
|
Placebo Comparator: 6 |
Drug: placebo
7mg/kg iv every 28 days for 3 infusions
|
Experimental: 7 |
Drug: RO4905417
7mg/kg iv every 28 days for 3 infusions
|
Placebo Comparator: 8 |
Drug: placebo
7mg/kg iv every 28 days for 3 infusions
|
Experimental: 9 |
Drug: RO4905417
20mg/kg iv every 28 days for 3 infusions
|
- Safety: Adverse events; clinical laboratory tests; physical examination; vital signs including ECG. [ Time Frame: Throughout study ]
- Pharmacodynamics: bleeding time; protein/vascular markers [ Time Frame: Throughout study ]
- Pharmacokinetics of RO4905417 [ Time Frame: Throughout study ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- healthy males and females aged 18-65 years (Arms 1,2,5,6,9,10);
- BMI 18-30kg/m2 (Arms 1,2,5,6,9,10);
- males and females aged 45-75 years with confirmed stable PAD (Arms 3,4,7,8,11,12);
- on a stable dose of statin, aspirin or clopidogrel for at least one month prior to the study (Arms 3,4,7,8,11,12);
- BMI 17.5-35kg/m2 (Arms 3,4,7,8,11,12).
Exclusion Criteria:
- patients with pain at rest and/or local complications;
- history of any cardiovascular event within the previous 6 months;
- treatment with drugs potentially affecting coagulation time or platelet aggregation (except aspirin or clopidogrel);
- evidence of hepatic or renal impairment;
- history of bleeding disorders.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00760565
United States, Florida | |
Gainesville, Florida, United States, 32605 | |
United States, Ohio | |
Cincinnati, Ohio, United States, 45219 | |
Cincinnati, Ohio, United States, 45227 | |
United States, Texas | |
San Antonio, Texas, United States, 78229 | |
Australia | |
Heidelberg, Australia, 3084 | |
Canada, Quebec | |
Gatineau, Quebec, Canada, J8Y 6S9 | |
Montreal, Quebec, Canada, H1T 1C8 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00760565 History of Changes |
Other Study ID Numbers: |
BP21617 |
First Posted: | September 26, 2008 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | November 2016 |
Additional relevant MeSH terms:
Peripheral Arterial Disease Peripheral Vascular Diseases Atherosclerosis Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |