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A Multiple Ascending Dose Study of RO4905417 in Healthy Volunteers and Patients With Peripheral Arterial Disease (PAD).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00760565
First received: September 25, 2008
Last updated: November 3, 2014
Last verified: November 2014

September 25, 2008
November 3, 2014
September 2008
June 2011   (final data collection date for primary outcome measure)
Safety: Adverse events; clinical laboratory tests; physical examination; vital signs including ECG. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00760565 on ClinicalTrials.gov Archive Site
  • Pharmacodynamics: bleeding time; protein/vascular markers [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Pharmacokinetics of RO4905417 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Multiple Ascending Dose Study of RO4905417 in Healthy Volunteers and Patients With Peripheral Arterial Disease (PAD).
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

This single center, multiple ascending dose study will assess the safety, tolera bility, 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/k g) or placebo iv every 28 days for a total of 3 infusions. In addition, two grou ps of 6 PAD patients will receive RO4905417 (either 3mg/kg, 7mg/kg) or placebo a nd 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 ne xt dose. All subjects will receive 3 doses of RO4905417 or matching placebo at 2 8 day intervals. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Peripheral Arterial Disease (PAD)
  • Drug: placebo
    3mg/kg iv every 28 days for 3 infusions
  • Drug: placebo
    20mg/kg iv every 28 days for 3 infusions
  • Drug: placebo
    7mg/kg iv every 28 days for 3 infusions
  • Drug: RO4905417
    3mg/kg iv every 28 days for 3 infusions
  • Drug: RO4905417
    7mg/kg iv every 28 days for 3 infusions
  • Drug: RO4905417
    20mg/kg iv every 28 days for 3 infusions
  • Experimental: 1
    Intervention: Drug: RO4905417
  • Placebo Comparator: 10
    Intervention: Drug: placebo
  • Experimental: 11
    Intervention: Drug: RO4905417
  • Placebo Comparator: 12
    Intervention: Drug: placebo
  • Placebo Comparator: 2
    Intervention: Drug: placebo
  • Experimental: 3
    Intervention: Drug: RO4905417
  • Placebo Comparator: 4
    Intervention: Drug: placebo
  • Experimental: 5
    Intervention: Drug: RO4905417
  • Placebo Comparator: 6
    Intervention: Drug: placebo
  • Experimental: 7
    Intervention: Drug: RO4905417
  • Placebo Comparator: 8
    Intervention: Drug: placebo
  • Experimental: 9
    Intervention: Drug: RO4905417
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada
 
NCT00760565
BP21617
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP