Stable AnginaPhase 2/3AGENT-4NCT00185263
Safety and Efficacy of Intracoronary Ad5FGF-4 in Patients With Stable Angina
A Phase 2/3 study of Stable Angina, run by Cardium Therapeutics.
Trial summary
The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4 is effective in improving exercise capacity measured by exercise treadmill testing, angina functional class, patient symptoms, quality of life, and cardiovascular outcomes. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Stable Angina
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- Mar 2002to Nov 2008
- Phase
- Phase 2/3
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CCS class II - IV, technically unsuitable for revascularization by CABG or PTCA able to exercise between 3 and 10 minutes on treadmill
Who cannot join
- Unstable angina, CCS class 1 angina optimal candidates for revascularization
About this study
Official title: A Multinational Multicenter, Randomized , Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Patients With Stable Angina
The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4 is effective in improving exercise capacity measured by exercise treadmill testing, angina functional class, patient symptoms, quality of life, and cardiovascular outcomes. To doses are to be studied, 2.87x10(8) and 2.87x10(9) viral particles, to evaluate the dose-response of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.
- Conditions
- Stable Angina
- Being tested
- AdF5FGF-4 vs. Placebo
- Keywords
- angina, FGF-4, angiogenesis, adenovector, growth factor, myocardial ischemia, revascularization
- Medical subject headings
- Angina, Stable, Angina Pectoris, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdF5FGF-4 vs. PlaceboGenetic
Intracoronary infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ad5FGF-4 Receives: Genetic: AdF5FGF-4 vs. Placebo |
| 2 | Experimental | Ad5FGF-4 Receives: Genetic: AdF5FGF-4 vs. Placebo |
| 3 | Placebo comparator | Placebo Receives: Genetic: AdF5FGF-4 vs. Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treadmill exercise duration
Measured: Week 12
Secondary outcomes (1)
Time to coronary events
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMar 2002
- Primary completionJan 2005
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardium Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paul Foster, MD, Study director, Cardium Therapeutics, 12255 El Camino Real, Suite 250, San Diego, CA 92130, USA, +1-858-436-1000
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185263
- Sponsor's protocol ID
- 305602
- Acronym
- AGENT-4
- Status last verified
- Nov 2008
- First submitted
- 10 Sep 2005
- Last updated
- 6 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Henry TD, Grines CL, Watkins MW, Dib N, Barbeau G, Moreadith R, Andrasfay T, Engler RL. Effects of Ad5FGF-4 in patients with angina: an analysis of pooled data from the AGENT-3 and AGENT-4 trials. J Am Coll Cardiol. 2007 Sep 11;50(11):1038-46. doi: 10.1016/j.jacc.2007.06.010. Epub 2007 Aug 24.
PubMed 17825712
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational Multicenter, Randomized , Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Patients With Stable Angina
- ClinicalTrials.gov ID
- NCT00185263
- Acronym / sponsor ID
- AGENT-4 / 305602
- Conditions
- Stable Angina
- Keywords
- angina, FGF-4, angiogenesis, adenovector, growth factor, myocardial ischemia, revascularization
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Cardium TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Jan 2005 (actual)
- Study completion
- Nov 2008 (estimated)
- First posted
- 16 Sep 2005 (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.
The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4 is effective in improving exercise capacity measured by exercise treadmill testing, angina functional class, patient symptoms, quality of life, and cardiovascular outcomes. To doses are to be studied, 2.87x10(8) and 2.87x10(9) viral particles, to evaluate the dose-response of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Genetic: AdF5FGF-4 vs. PlaceboAd5FGF-4 |
| 2 | Experimental | Genetic: AdF5FGF-4 vs. PlaceboAd5FGF-4 |
| 3 | Placebo comparator | Genetic: AdF5FGF-4 vs. PlaceboPlacebo |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CCS class II - IV, technically unsuitable for revascularization by CABG or PTCA able to exercise between 3 and 10 minutes on treadmill
Key exclusion criteria (1 listed)
- Unstable angina, CCS class 1 angina optimal candidates for revascularization
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 |
|---|---|---|
| AdF5FGF-4 vs. PlaceboIntracoronary infusion | Genetic | 1, 2, 3 |
Primary outcome
Treadmill exercise duration
Time frame: Week 12
1 secondary outcome
Time to coronary events
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2008.
- Derived from this study: PubMed 17825712Henry TD, Grines CL, Watkins MW, Dib N, Barbeau G, Moreadith R, Andrasfay T, Engler RL. Effects of Ad5FGF-4 in patients with angina: an analysis of pooled data from the AGENT-3 and AGENT-4 trials. J Am Coll Cardiol. 2007 Sep 11;50(11):1038-46. doi: 10.1016/j.jacc.2007.06.010. Epub 2007 Aug 24.
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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.
Paul Foster, MD study director
Cardium Therapeutics, 12255 El Camino Real, Suite 250, San Diego, CA 92130, USA, +1-858-436-1000
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study of Stable Angina, run by Cardium Therapeutics.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Treadmill exercise duration (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00185263, which also lists 1 linked publication.
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 6 Nov 2008.