Status:
COMPLETED
A Multiple Ascending Dose Study of RO4905417 in Healthy Volunteers and Patients With Peripheral Arterial Disease (PAD).
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Peripheral Arterial Disease (PAD)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This single center, multiple ascending dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO4905417 at different doses in healthy volunteers and patients with pe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00760565
Start Date
September 1 2008
End Date
June 1 2011
Last Update
November 2 2016
Active Locations (7)
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1
Gainesville, Florida, United States, 32605
2
Cincinnati, Ohio, United States, 45219
3
Cincinnati, Ohio, United States, 45227
4
San Antonio, Texas, United States, 78229