Peripheral Arterial Disease (PAD)Phase 1NCT00760565
A Multiple Ascending Dose Study of RO4905417 in Healthy Volunteers and Patients With Peripheral Arterial Disease (PAD).
A Phase 1 study testing RO4905417 in people with Peripheral Arterial Disease (PAD), run by Hoffmann-La Roche at 7 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Arterial Disease (PAD)
- What is being tested?
- RO4905417
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Sep 2008to Jun 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States4 sites
Study site
Cincinnati, Ohio, 45219
Study site
Cincinnati, Ohio, 45227
Study site
Gainesville, Florida, 32605
Study site
San Antonio, Texas, 78229
Canada2 sites
Study site
Gatineau, Quebec, J8Y 6S9
Study site
Montreal, Quebec, H1T 1C8
About this study
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
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.
- Conditions
- Peripheral Arterial Disease (PAD)
- Being tested
- RO4905417, placebo
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO4905417Drug
3mg/kg iv every 28 days for 3 infusions
RO4905417Drug
20mg/kg iv every 28 days for 3 infusions
RO4905417Drug
7mg/kg iv every 28 days for 3 infusions
placeboDrug
3mg/kg iv every 28 days for 3 infusions
placeboDrug
7mg/kg iv every 28 days for 3 infusions
placeboDrug
20mg/kg iv every 28 days for 3 infusions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: RO4905417 |
| 10 | Placebo comparator | Not described Receives: Drug: placebo |
| 11 | Experimental | Not described Receives: Drug: RO4905417 |
| 12 | Placebo comparator | Not described Receives: Drug: placebo |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
| 3 | Experimental | Not described Receives: Drug: RO4905417 |
| 4 | Placebo comparator | Not described Receives: Drug: placebo |
| 5 | Experimental | Not described Receives: Drug: RO4905417 |
| 6 | Placebo comparator | Not described Receives: Drug: placebo |
| 7 | Experimental | Not described Receives: Drug: RO4905417 |
| 8 | Placebo comparator | Not described Receives: Drug: placebo |
| 9 | Experimental | Not described Receives: Drug: RO4905417 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Adverse events; clinical laboratory tests; physical examination; vital signs including ECG.
Measured: Throughout study
Secondary outcomes (2)
Pharmacodynamics: bleeding time; protein/vascular markers
Measured: Throughout study
Pharmacokinetics of RO4905417
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Disease (PAD)Studies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760565
- Sponsor's protocol ID
- BP21617
- Status last verified
- Nov 2016
- First submitted
- 25 Sep 2008
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00760565
- Acronym / sponsor ID
- BP21617
- Conditions
- Peripheral Arterial Disease (PAD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RO4905417 |
| 10 | Placebo comparator | Drug: placebo |
| 11 | Experimental | Drug: RO4905417 |
| 12 | Placebo comparator | Drug: placebo |
| 2 | Placebo comparator | Drug: placebo |
| 3 | Experimental | Drug: RO4905417 |
| 4 | Placebo comparator | Drug: placebo |
| 5 | Experimental | Drug: RO4905417 |
| 6 | Placebo comparator | Drug: placebo |
| 7 | Experimental | Drug: RO4905417 |
| 8 | Placebo comparator | Drug: placebo |
| 9 | Experimental | Drug: RO4905417 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO49054173mg/kg iv every 28 days for 3 infusions | Drug | 1, 3 |
| RO490541720mg/kg iv every 28 days for 3 infusions | Drug | 11, 9 |
| RO49054177mg/kg iv every 28 days for 3 infusions | Drug | 5, 7 |
| placebo3mg/kg iv every 28 days for 3 infusions | Drug | 2, 4 |
| placebo7mg/kg iv every 28 days for 3 infusions | Drug | 6, 8 |
| placebo20mg/kg iv every 28 days for 3 infusions | Drug | 10, 12 |
Primary outcome
Safety: Adverse events; clinical laboratory tests; physical examination; vital signs including ECG.
Time frame: Throughout study
2 secondary outcomes
Pharmacodynamics: bleeding time; protein/vascular markers
Time frame: Throughout study
Pharmacokinetics of RO4905417
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO4905417 in people with Peripheral Arterial Disease (PAD), run by Hoffmann-La Roche at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Adverse events; clinical laboratory tests; physical examination; vital signs including ECG. (time frame: Throughout study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.