Myocardial IschemiaPhase 4ANISSANCT00143195
Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina
A Phase 4 study testing Amlodipine, iso- 5 - mononitrate and Blood tests in people with Myocardial Ischemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 12 sites in Greece.
Trial summary
The objective of study is to compare the anti-ischemic efficacy and safety profiles of once daily amlodipine or isosorbide-5-mononitrate in the treatment of stable asymptomatic and symptomatic myocardial ischemia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- Amlodipine, iso- 5 - mononitrate and Blood tests
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 12 sitesGreece
- Study dates
- Apr 2001to Jan 2005
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients > =18 years of age with diagnosed clinically stable angina pectoris
Who cannot join
- Patients with congestive heart failure, clinically significant cardiovascular disease, standing systolic blood pressure of less than 100mmHg, concomitant anti-anginal therapies similar to sublingual NTG
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Greece12 sites
Pfizer Investigational Site
Athens, Attica, 11527
Pfizer Investigational Site
Athens, 123 51
Pfizer Investigational Site
Athens
Pfizer Investigational Site
Holargos/Athens, 11525
Pfizer Investigational Site
Loannina, 45500
Pfizer Investigational Site
N. Ionia, 143 88
Pfizer Investigational Site
Pátrai, 26335
Pfizer Investigational Site
Rio, Patra, 26499
Pfizer Investigational Site
Thessaloniki, 546 36
Pfizer Investigational Site
Thessaloniki, 54639
Pfizer Investigational Site
Voula/Athens
Pfizer Investigational Site
Zakynthos, 29100
About this study
Official title: Open Label Study Comparing Amlodipine vs Long-acting Nitrates in Patients With Chronic Stable Angina.
The objective of study is to compare the anti-ischemic efficacy and safety profiles of once daily amlodipine or isosorbide-5-mononitrate in the treatment of stable asymptomatic and symptomatic myocardial ischemia
- Conditions
- Myocardial Ischemia
- Being tested
- Amlodipine, iso- 5 - mononitrate, Blood tests, Exercise Stress Test
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
iso- 5 - mononitrateDrug
Blood testsProcedure or surgery
Exercise Stress TestProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the time to 1mm ST depression
Secondary outcomes (1)
The number of patients experiencing angina attacks The frequency of hospitalizations due to angina attacks Time to onset of 1mm ST segment depression Total external workload performed Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startApr 2001
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143195
- Sponsor's protocol ID
- A0531076
- Acronym
- ANISSA
- Status last verified
- Jan 2021
- First submitted
- 31 Aug 2005
- Last updated
- 28 Jan 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study Comparing Amlodipine vs Long-acting Nitrates in Patients With Chronic Stable Angina.
- ClinicalTrials.gov ID
- NCT00143195
- Acronym / sponsor ID
- ANISSA / A0531076
- Conditions
- Myocardial Ischemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2001
- Study completion
- Jan 2005
- First posted
- 2 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 objective of study is to compare the anti-ischemic efficacy and safety profiles of once daily amlodipine or isosorbide-5-mononitrate in the treatment of stable asymptomatic and symptomatic myocardial ischemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatients > =18 years of age with diagnosed clinically stable angina pectoris
Key exclusion criteria (1 listed)
- Patients with congestive heart failure, clinically significant cardiovascular disease, standing systolic blood pressure of less than 100mmHg, concomitant anti-anginal therapies similar to sublingual NTG
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 |
|---|---|---|
| Amlodipine | Drug | – |
| iso- 5 - mononitrate | Drug | – |
| Blood tests | Procedure or surgery | – |
| Exercise Stress Test | Procedure or surgery | – |
Primary outcome
Evaluate the time to 1mm ST depression
1 secondary outcome
The number of patients experiencing angina attacks The frequency of hospitalizations due to angina attacks Time to onset of 1mm ST segment depression Total external workload performed Safety
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 28 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amlodipine, iso- 5 - mononitrate and Blood tests in people with Myocardial Ischemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 12 sites in Greece.
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: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Greece. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Evaluate the time to 1mm ST depression. 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 28 Jan 2021.