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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00760565