Chronic Stable AnginaPhase 2NCT00518921
Capadenoson in Angina Pectoris
A Phase 2 study testing Capadenoson (BAY 68-4986) in people with Chronic Stable Angina, run by Bayer at 36 sites in 6 countries.
Trial summary
This is a multi-center and multi-national,randomized, double blind, placebo-controlled, 28-day treatment study with BAY 68-4986 taken orally or a matching placebo. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Chronic Stable Angina
- What is being tested?
- Capadenoson (BAY 68-4986)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 36 sitesin 6 countries
- Study dates
- Mar 2008to Nov 2008
- Phase
- Phase 2
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The primary diagnosis is chronic stable angina of mild-moderate intensity as defined by the Canadian Cardiovascular Society Functional Class II-III, in the presence of definitive coronary artery disease.
- Male or female subjects aged 35 to 75 years (if female, only if postmenopausal or permanently sterilized)
- Stable angina of mild-moderate intensity (Canadian class II-III) with anti-anginal medication not changed for the last 5 weeks
Who cannot join
- Inability to withdraw current anti-anginal therapy
- Inability to withdraw any concomitant therapy that would interfere with interpretation of study results
Trial locations and contacts
36 sites in 6 countries.
36 sites in 6 countries
Poland12 sites
Study site
Bialystok, 15-276
Study site
Gdansk, 80-952
Study site
Gdynia, 81-519
Study site
Katowice, 40-635
Study site
Krakow, 30-501
Study site
Legnica, 59-220
Study site
Lodz, 91-347
Study site
Starogard Gdański, 83-200
Study site
Szczecin, 70-111
Study site
Warsaw, 03-401
Study site
Wroclaw, 50-420
Study site
Wroclaw, 50-981
Czechia8 sites
Study site
Brno, 656 91
Study site
Hodonín, 695 26
Study site
Kroměříž, 767 55
Study site
Olomouc, 775 20
Study site
Ostrava, 708 52
Study site
Pilsen, 30599
Study site
Prague, 158 00
Study site
Prague, 169 02
Hungary5 sites
Study site
Balatonfüred, 8230
Study site
Kecskemét, 6000
Study site
Miskolc, 3526
Study site
Pécs, 7624
Study site
Zalaegerszeg, 8900
Italy4 sites
Study site
Genova, 16132
Study site
Mestre, Venezia, 30174
Study site
Pavia, 27100
Study site
Trieste, 34100
Slovakia4 sites
Study site
Bratislava, 811 04
Study site
Bratislava, 813 69
Study site
Nitra, 949 01
Study site
Nové Zámky, 940 34
Israel3 sites
Study site
Hadera, Israel, 38100
Study site
Rehovot, Israel, 76100
Study site
Safed, Israel, 13100
About this study
Official title: Phase IIa Efficacy and Safety Trial of Capadenoson in Patients With Chronic Stable Angina
This is a multi-center and multi-national,randomized, double blind, placebo-controlled, 28-day treatment study with BAY 68-4986 taken orally or a matching placebo.
- Conditions
- Chronic Stable Angina
- Being tested
- Capadenoson (BAY 68-4986), Placebo
- Keywords
- adenosin agonist, chronic stable angina
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capadenoson (BAY 68-4986)Drug
1mg Capadenoson, double dummy
Capadenoson (BAY 68-4986)Drug
2mg Capadenoson, double dummy
Capadenoson (BAY 68-4986)Drug
4mg Capadenoson, double dummy
PlaceboDrug
Placebo, double dummy
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Capadenoson (BAY 68-4986) |
| Arm 2 | Experimental | Not described Receives: Drug: Capadenoson (BAY 68-4986) |
| Arm 3 | Experimental | Not described Receives: Drug: Capadenoson (BAY 68-4986) |
| Arm 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total exercise time
Measured: 28 days for ETT and 42 days for safety
Secondary outcomes (1)
Time to angina onset
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2007 (estimated)
- Study startMar 2008
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stable AnginaStudies of the same condition, open and under way.
- More trials run by BayerThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518921
- Sponsor's protocol ID
- 12484
- Other IDs
- EudraCT 2007-000425-22
- Status last verified
- Jan 2011
- First submitted
- 20 Aug 2007
- Last updated
- 13 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Efficacy and Safety Trial of Capadenoson in Patients With Chronic Stable Angina
- ClinicalTrials.gov ID
- NCT00518921
- Acronym / sponsor ID
- 12484
- Conditions
- Chronic Stable Angina
- Keywords
- adenosin agonist, chronic stable angina
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Study completion
- Nov 2008 (estimated)
- First posted
- 21 Aug 2007 (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 is a multi-center and multi-national,randomized, double blind, placebo-controlled, 28-day treatment study with BAY 68-4986 taken orally or a matching placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Capadenoson (BAY 68-4986) |
| Arm 2 | Experimental | Drug: Capadenoson (BAY 68-4986) |
| Arm 3 | Experimental | Drug: Capadenoson (BAY 68-4986) |
| Arm 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The primary diagnosis is chronic stable angina of mild-moderate intensity as defined by the Canadian Cardiovascular Society Functional Class II-III, in the presence of definitive coronary artery disease.
- Male or female subjects aged 35 to 75 years (if female, only if postmenopausal or permanently sterilized)
- Stable angina of mild-moderate intensity (Canadian class II-III) with anti-anginal medication not changed for the last 5 weeks
Key exclusion criteria (2 listed)
- Inability to withdraw current anti-anginal therapy
- Inability to withdraw any concomitant therapy that would interfere with interpretation of study results
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 |
|---|---|---|
| Capadenoson (BAY 68-4986)1mg Capadenoson, double dummy | Drug | Arm 1 |
| Capadenoson (BAY 68-4986)2mg Capadenoson, double dummy | Drug | Arm 2 |
| Capadenoson (BAY 68-4986)4mg Capadenoson, double dummy | Drug | Arm 3 |
| PlaceboPlacebo, double dummy | Drug | Arm 4 |
Primary outcome
Total exercise time
Time frame: 28 days for ETT and 42 days for safety
1 secondary outcome
Time to angina onset
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2011.
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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.
Bayer Study Director study director
Bayer
36 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capadenoson (BAY 68-4986) in people with Chronic Stable Angina, run by Bayer at 36 sites in 6 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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 13 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Poland, Czechia, Hungary, Italy, Slovakia and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Total exercise time (time frame: 28 days for ETT and 42 days for safety). 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 13 Jan 2011.