Cardiovascular DiseasePhase 1DURATIONNCT02370680
Length of Effect of Extended Release Aspirin on Platelets in Patients With Diabetes and Heart Disease
A Phase 1 study testing Aspirin and Durlaza™ in people with Cardiovascular Disease, run by New Haven Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study is being conducted to evaluate the safety and the length of effect on platelet build-up in the arteries of Durlaza™ as compared to immediate-release Bayer® aspirin 81 mg or subject's current aspirin 81 mg of choice in patients who have Type 2 diabetes mellitus and cardiovascular disease or multiple risk… 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?
- Aspirin and Durlaza™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jul 2015
- 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
- Male or non-lactating, non-pregnant female subjects
- A history of Type 2 Diabetes and with history of at least one of the following: Coronary Artery Disease, Peripheral Vascular Disease, or Ischemic Stroke, along with at least 2 CVD risk factors (obese, smoker, ≥ 55 years of age, prior thrombotic event)
Who cannot join
- Sensitivity to aspirin or any NSAID (nonsteroidal antiinflammatory drug),
- Evidence of uncontrolled or unstable cardio- or cerebrovascular disorder,
- Presence of uncontrolled or chronic medical illness, GI disorder or surgery leading to impaired drug absorption, clinically significant abnormal baseline ECG, history of hepatitis, malignancy within the past five years, or HIV, history of alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Platelet and Thrombosis Research, LLC
Baltimore, Maryland, 21215
About this study
Official title: Durability of Antiplatelet Effect of a Novel Extended-Release Formulation of Acetylsalicylic Acid, Durlaza in CVD (Cardiovascular Disease) Patients at Risk of High Platelet Turnover
This study is being conducted to evaluate the safety and the length of effect on platelet build-up in the arteries of Durlaza™ as compared to immediate-release Bayer® aspirin 81 mg or subject's current aspirin 81 mg of choice in patients who have Type 2 diabetes mellitus and cardiovascular disease or multiple risk factors of developing cardiovascular disease.
- Conditions
- Cardiovascular Disease
- Being tested
- Aspirin, Durlaza™
- Keywords
- Antiplatelet, Antiplatelet therapy, platelet turnover, high platelet turnover, platelet aggregation, cardiovascular disease, coronary artery disease, diabetes mellitus
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called Bayer aspirin
steady-state run-in prior to Durlaza treatment
Durlaza™Drug
comparison of different numbers of capsules
| Study group | Role | What they receive |
|---|---|---|
| Durlaza™, 1 capsule | Experimental | Aspirin run-in, followed with Durlaza™, one capsule QD (quaque die), for 14 ± 4 days and an in-patient visit Receives: Drug: Aspirin; Drug: Durlaza™ |
| Durlaza™, 2 capsules | Experimental | in a rollover with 10 subjects from the first arm, an aspirin run-in, followed by Durlaza™, two capsules QD, for 14 ± 4 days and an in-patient visit Receives: Drug: Aspirin; Drug: Durlaza™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in platelet aggregation
Measured: During the 26-hour hospital stays, outcomes will be measured at various timepoints
Secondary outcomes (2)
Reactive Hyperemia Index
Measured: During the 26-hour hospital stays, outcomes will be measured at various timepoints
Safety as measured by the number and system class of adverse events reported in each treatment arm
Measured: participants are followed for approximately 40 to 65 days once they start study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2015
- Study completionJul 2015
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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Haven Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Gurbel, MD, Principal investigator, Platelet Thrombosis Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370680
- Sponsor's protocol ID
- NHP-ASP-102
- Acronym
- DURATION
- Status last verified
- Aug 2015
- First submitted
- 11 Feb 2015
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Durability of Antiplatelet Effect of a Novel Extended-Release Formulation of Acetylsalicylic Acid, Durlaza in CVD (Cardiovascular Disease) Patients at Risk of High Platelet Turnover
- ClinicalTrials.gov ID
- NCT02370680
- Acronym / sponsor ID
- DURATION / NHP-ASP-102
- Conditions
- Cardiovascular Disease
- Keywords
- Antiplatelet, Antiplatelet therapy, platelet turnover, high platelet turnover, platelet aggregation, cardiovascular disease, coronary artery disease, diabetes mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- New Haven Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 Feb 2015 (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 study is being conducted to evaluate the safety and the length of effect on platelet build-up in the arteries of Durlaza™ as compared to immediate-release Bayer® aspirin 81 mg or subject's current aspirin 81 mg of choice in patients who have Type 2 diabetes mellitus and cardiovascular disease or multiple risk factors of developing cardiovascular disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Durlaza™, 1 capsule | Experimental | Drug: Aspirin, Drug: Durlaza™Aspirin run-in, followed with Durlaza™, one capsule QD (quaque die), for 14 ± 4 days and an in-patient visit |
| Durlaza™, 2 capsules | Experimental | Drug: Aspirin, Drug: Durlaza™in a rollover with 10 subjects from the first arm, an aspirin run-in, followed by Durlaza™, two capsules QD, for 14 ± 4 days and an in-patient visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or non-lactating, non-pregnant female subjects
- A history of Type 2 Diabetes and with history of at least one of the following: Coronary Artery Disease, Peripheral Vascular Disease, or Ischemic Stroke, along with at least 2 CVD risk factors (obese, smoker, ≥ 55 years of age, prior thrombotic event)
Key exclusion criteria (3 listed)
- Sensitivity to aspirin or any NSAID (nonsteroidal antiinflammatory drug),
- Evidence of uncontrolled or unstable cardio- or cerebrovascular disorder,
- Presence of uncontrolled or chronic medical illness, GI disorder or surgery leading to impaired drug absorption, clinically significant abnormal baseline ECG, history of hepatitis, malignancy within the past five years, or HIV, history of alcohol or drug abuse.
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 |
|---|---|---|
| AspirinAlso: Bayer aspirinsteady-state run-in prior to Durlaza treatment | Drug | Durlaza™, 1 capsule, Durlaza™, 2 capsules |
| Durlaza™comparison of different numbers of capsules | Drug | Durlaza™, 1 capsule, Durlaza™, 2 capsules |
Primary outcome
change in platelet aggregation
Time frame: During the 26-hour hospital stays, outcomes will be measured at various timepoints
2 secondary outcomes
Reactive Hyperemia Index
Time frame: During the 26-hour hospital stays, outcomes will be measured at various timepoints
Safety as measured by the number and system class of adverse events reported in each treatment arm
Time frame: participants are followed for approximately 40 to 65 days once they start study medication
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 6 Aug 2015.
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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 Gurbel, MD principal investigator
Platelet Thrombosis Research, LLC
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 Aspirin and Durlaza™ in people with Cardiovascular Disease, run by New Haven Pharmaceuticals, Inc. at 1 site in United States.
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 2 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 6 Aug 2015. 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 United States. 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?
change in platelet aggregation (time frame: During the 26-hour hospital stays, outcomes will be measured at various timepoints). 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 6 Aug 2015.