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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
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 peripheral arterial disease. Three groups of 10 healthy volunteers will receive RO4905417 (either 3mg/kg, 7mg/kg or 20mg/kg) or placebo iv every 28 days for a total of 3 infusions. In addition, two groups of 6 PAD patients will receive RO4905417 (either 3mg/kg, 7mg/kg) or placebo and 1 group of 20 PAD patients will receive 20mg/kg RO4905417 or placebo iv every 28 days for a total of three infusions. The study will have an adaptive design with ongoing assessment of safety and tolerability prior to initiation of the next dose. All subjects will receive 3 doses of RO4905417 or matching placebo at 28 day intervals. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease (PAD) Drug: RO4905417 Drug: placebo Phase 1

Study Design
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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

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U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Safety: Adverse events; clinical laboratory tests; physical examination; vital signs including ECG. [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. Pharmacodynamics: bleeding time; protein/vascular markers [ Time Frame: Throughout study ]
  2. Pharmacokinetics of RO4905417 [ Time Frame: Throughout study ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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