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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00760565




Registration number
NCT00760565
Ethics application status
Date submitted
25/09/2008
Date registered
26/09/2008
Date last updated
2/11/2016

Titles & IDs
Public title
A Multiple Ascending Dose Study of RO4905417 in Healthy Volunteers and Patients With Peripheral Arterial Disease (PAD).
Scientific 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
Secondary ID [1] 0 0
BP21617
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease (PAD) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RO4905417
Treatment: Drugs - RO4905417
Treatment: Drugs - RO4905417
Treatment: Drugs - placebo
Treatment: Drugs - placebo
Treatment: Drugs - placebo

Experimental: 1 -

Placebo Comparator: 10 -

Experimental: 11 -

Placebo Comparator: 12 -

Placebo Comparator: 2 -

Experimental: 3 -

Placebo Comparator: 4 -

Experimental: 5 -

Placebo Comparator: 6 -

Experimental: 7 -

Placebo Comparator: 8 -

Experimental: 9 -


Treatment: Drugs: RO4905417
3mg/kg iv every 28 days for 3 infusions

Treatment: Drugs: RO4905417
20mg/kg iv every 28 days for 3 infusions

Treatment: Drugs: RO4905417
7mg/kg iv every 28 days for 3 infusions

Treatment: Drugs: placebo
3mg/kg iv every 28 days for 3 infusions

Treatment: Drugs: placebo
7mg/kg iv every 28 days for 3 infusions

Treatment: Drugs: placebo
20mg/kg iv every 28 days for 3 infusions
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety: Adverse events; clinical laboratory tests; physical examination; vital signs including ECG.
Timepoint [1] 0 0
Throughout study
Secondary outcome [1] 0 0
Pharmacodynamics: bleeding time; protein/vascular markers
Timepoint [1] 0 0
Throughout study
Secondary outcome [2] 0 0
Pharmacokinetics of RO4905417
Timepoint [2] 0 0
Throughout study

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2011
Sample size
Target
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00760565
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00760565