Cardiovascular DiseasePhase 1NCT00425074
Pharmacodynamic-pharmacokinetic Trial, of Slow Release ASA, in the Platelet Functionalism.
A Phase 1 study testing slow release acetyl salicylic acid, ASA and SR-ASA in people with Cardiovascular Disease, run by Rottapharm Spain at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the platelet antiaggregant effect that a chronic treatment with ASA (150 mg) produces,comparing this effect between two formulations of ASA: normal and the one of sustained release, in patients with stable coronary disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- slow release acetyl salicylic acid, ASA and SR-ASA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2007to Jul 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous episodes of myocardial infarction
- Previous episodes of instable angina pectoris
- Previous coronary revascularization
- Significant arterial coronary disease
Who cannot join
- Patients with other pathologies that requires treatment with other antiaggregants
- Patients in treatment with low molecular weight heparin or oral anticoagulant
- Patients with antecedents of hypersensibility to ASA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacodynamic- Pharmacokinetic Trial, Comparative Double Blind, of the Chronic Administration of 150 mg of Slow Release ASA Versus 150 mg of Normal Release ASA, in the Platelet Functionalism.
The purpose of this study is to evaluate the platelet antiaggregant effect that a chronic treatment with ASA (150 mg) produces,comparing this effect between two formulations of ASA: normal and the one of sustained release, in patients with stable coronary disease.
Read the detailed description
A large clinical trials have established the efficacy of the antiaggregant products in patients with ischemic cardiopathy, stroke and intermittent claudication.
Without doubt, the acetylsalicylic acid (ASA) is the most used antiaggregant product, nevertheless, and spite of being centenarian, it last some questions pending regarding the most appropriate dose, mechanism of action implicated, the association with other drugs, and the pharmaceutical form in order to improve the efficacy and the safety of the ASA.
Some previous studies indicate that the slow release form of ASA has a different behaviour in the platelet effect in comparison with plain formulation.
The aim of this study is to demonstrate the best antiaggregant and safety profile of a low dose of a slow release formulation of ASA.
- Conditions
- Cardiovascular Disease
- Being tested
- slow release acetyl salicylic acid, ASA, SR-ASA
- Keywords
- slow release ASA, platelet functionalism, secondary cardiovascular prevention
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
slow release acetyl salicylic acidDrug
150 mg in capsules via oral, during 14 days.
ASADrug
normal release acetylsalicylic acid
SR-ASADrug
slow release acetylsalicylic acid 150 mg
| Study group | Role | What they receive |
|---|---|---|
| SR-ASA | Experimental | slow release acetylsalicylic acid 150 mg Receives: Drug: slow release acetyl salicylic acid; Drug: SR-ASA |
| ASA | Active comparator | normal release acetylsalicylic acid Receives: Drug: ASA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of the treatment with ASA (150 mg) produces on the thromboxan/prostacyclin balance and its repercussion in the platelet aggregation,comparing this effect between two formulations
Measured: 28 days
Secondary outcomes (1)
To evaluate the principal kinetic parameters of both galenic formulations of ASA.
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 posted22 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionJun 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rottapharm Spain
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eloy Rueda, MD, Principal investigator, Hosp. Universitario Virgen de la Victoria, Málaga (Spain)José Pedro de la Cruz, PhD, Principal investigator, Departmento de Farmacología y Terapéutica Clínica Facultad de Medicina, Universidad de MálagaJosé Antonio González Correa, PhD, Principal investigator, Departamento de Farmacología y Terapéutica Clínica Facultad de Medicna, Universidad de Málaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425074
- Sponsor's protocol ID
- TROM-EC-ECC-FIb
- Status last verified
- Jun 2011
- First submitted
- 19 Jan 2007
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic- Pharmacokinetic Trial, Comparative Double Blind, of the Chronic Administration of 150 mg of Slow Release ASA Versus 150 mg of Normal Release ASA, in the Platelet Functionalism.
- ClinicalTrials.gov ID
- NCT00425074
- Acronym / sponsor ID
- TROM-EC-ECC-FIb
- Conditions
- Cardiovascular Disease
- Keywords
- slow release ASA, platelet functionalism, secondary cardiovascular prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rottapharm SpainIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 22 Jan 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.
The purpose of this study is to evaluate the platelet antiaggregant effect that a chronic treatment with ASA (150 mg) produces,comparing this effect between two formulations of ASA: normal and the one of sustained release, in patients with stable coronary disease.
Detailed description
A large clinical trials have established the efficacy of the antiaggregant products in patients with ischemic cardiopathy, stroke and intermittent claudication.
Without doubt, the acetylsalicylic acid (ASA) is the most used antiaggregant product, nevertheless, and spite of being centenarian, it last some questions pending regarding the most appropriate dose, mechanism of action implicated, the association with other drugs, and the pharmaceutical form in order to improve the efficacy and the safety of the ASA.
Some previous studies indicate that the slow release form of ASA has a different behaviour in the platelet effect in comparison with plain formulation.
The aim of this study is to demonstrate the best antiaggregant and safety profile of a low dose of a slow release formulation of ASA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SR-ASA | Experimental | Drug: slow release acetyl salicylic acid, Drug: SR-ASAslow release acetylsalicylic acid 150 mg |
| ASA | Active comparator | Drug: ASAnormal release acetylsalicylic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Previous episodes of myocardial infarction
- Previous episodes of instable angina pectoris
- Previous coronary revascularization
- Significant arterial coronary disease
Key exclusion criteria (3 listed)
- Patients with other pathologies that requires treatment with other antiaggregants
- Patients in treatment with low molecular weight heparin or oral anticoagulant
- Patients with antecedents of hypersensibility to ASA
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 |
|---|---|---|
| slow release acetyl salicylic acid150 mg in capsules via oral, during 14 days. | Drug | SR-ASA |
| ASAnormal release acetylsalicylic acid | Drug | ASA |
| SR-ASAslow release acetylsalicylic acid 150 mg | Drug | SR-ASA |
Primary outcome
To evaluate the effect of the treatment with ASA (150 mg) produces on the thromboxan/prostacyclin balance and its repercussion in the platelet aggregation,comparing this effect between two formulations
Time frame: 28 days
1 secondary outcome
To evaluate the principal kinetic parameters of both galenic formulations of ASA.
Time frame: 28 days
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 8 Jun 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.
Eloy Rueda, MD principal investigator
Hosp. Universitario Virgen de la Victoria, Málaga (Spain)
José Pedro de la Cruz, PhD principal investigator
Departmento de Farmacología y Terapéutica Clínica Facultad de Medicina, Universidad de Málaga
José Antonio González Correa, PhD principal investigator
Departamento de Farmacología y Terapéutica Clínica Facultad de Medicna, Universidad de Málaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing slow release acetyl salicylic acid, ASA and SR-ASA in people with Cardiovascular Disease, run by Rottapharm Spain at 1 site in Spain.
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 4 inclusion and 3 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 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 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?
To evaluate the effect of the treatment with ASA (150 mg) produces on the thromboxan/prostacyclin balance and its repercussion in the platelet aggregation,comparing this effect between two formulations (time frame: 28 days). 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 8 Jun 2011.