HealthyPhase 4NCT02251184
Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH
A Phase 4 study testing Aggrenox, Dipyridamole and Aspirin in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Comparison of pharmacokinetics of dipyridamole administered as Aggrenox versus dipyridamole administered as the immediate release formulation plus aspirin, under conditions of reduced stomach acidity. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Aggrenox, Dipyridamole and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Oct 2000to Nov 2000
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age 40 - 65 years, inclusive, at time of Visit 1
- Stomach pH > 4.0 on three consecutive measurements separated by at least five minutes, measured at Visits 3B and 5B prior to dosing with Aggrenox or dipyridamole-aspirin (DP-ASA)
Who cannot join
- Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and considered by the investigator to be of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders considered by the investigator to be of clinical relevance
- History of gastro-intestinal ulcer, perforation or bleeding
- Surgery of the gastro-intestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy), neurological disorders, or psychiatric disorders
- Chronic or relevant acute infections. Screening tests will be performed for HIV, hepatitis B, and hepatitis C
Show all 23Show fewer
- History of hypersensitivity to Aggrenox or any of the components or excipients
- Intake of drugs with a long dominant half-life (>24 hours) 1 month or less prior to Visit 1
- Use of any drugs which might influence the results of the trial ten days or less prior to Visit 1
- Participation in another trial with an investigational drug 1 month or less prior to Visit 1
- Known alcohol abuse
- Known drug abuse (a drug screening test will be performed at Visits 1, 3, and 5)
- Blood donation 1 month or less prior to Visit 1
- Excessive physical activities five days or less prior to Visit 1
- History of hemorrhagic diathesis
- History of bronchial asthma
- Any laboratory value outside the reference range, considered by the investigator to be of clinical relevance
- For female subjects:
- Nursing
- Pregnancy
- Positive pregnancy test
- No adequate contraception (adequate contraception includes sterilization, intrauterine device, or oral contraceptives)
- Inability to maintain adequate contraception during the whole study period
About this study
Official title: Comparison of Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH by the Prior Administration of a Proton-pump Inhibitor: An Open-label 2-way Randomized Cross-over Study in Healthy Male and Female Subjects Age 40-65.
Comparison of pharmacokinetics of dipyridamole administered as Aggrenox versus dipyridamole administered as the immediate release formulation plus aspirin, under conditions of reduced stomach acidity.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AggrenoxDrug
DipyridamoleDrug
AspirinDrug
LansoprazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Aggrenox | Experimental | extended release Receives: Drug: Aggrenox; Drug: Lansoprazole |
| dipyridamole+aspirin | Active comparator | immediate release Receives: Drug: Dipyridamole; Drug: Aspirin; Drug: Lansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the concentration time curve (AUC0-12)
Measured: up to 12 hours
Secondary outcomes (7)
area under the concentration time curve 0-48 hours (AUC0-48)
Measured: up to 48 hours
area under the concentration time curve extrapolated to infinity (AUC0-inf)
Measured: up to 3 days
maximum observed plasma concentration (Cmax)
Measured: up to 3 days
time to maximum observed plasma concentration (Tmax)
Measured: up to 3 days
terminal half life (t1/2)
Measured: up to 3 days
number of subjects with adverse events
Measured: up to 3 weeks
number of subjects with clinically significant changes in laboratory findings
Measured: up to 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startOct 2000
- Primary completionNov 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251184
- Sponsor's protocol ID
- 9.146
- Status last verified
- Sep 2014
- First submitted
- 25 Sep 2014
- Last updated
- 29 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH by the Prior Administration of a Proton-pump Inhibitor: An Open-label 2-way Randomized Cross-over Study in Healthy Male and Female Subjects Age 40-65.
- ClinicalTrials.gov ID
- NCT02251184
- Acronym / sponsor ID
- 9.146
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2000
- Primary completion
- Nov 2000 (actual)
- First posted
- 29 Sep 2014 (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.
Comparison of pharmacokinetics of dipyridamole administered as Aggrenox versus dipyridamole administered as the immediate release formulation plus aspirin, under conditions of reduced stomach acidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aggrenox | Experimental | Drug: Aggrenox, Drug: Lansoprazoleextended release |
| dipyridamole+aspirin | Active comparator | Drug: Dipyridamole, Drug: Aspirin, Drug: Lansoprazoleimmediate release |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age 40 - 65 years, inclusive, at time of Visit 1
- Stomach pH > 4.0 on three consecutive measurements separated by at least five minutes, measured at Visits 3B and 5B prior to dosing with Aggrenox or dipyridamole-aspirin (DP-ASA)
Key exclusion criteria (23 listed)
- Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and considered by the investigator to be of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders considered by the investigator to be of clinical relevance
- History of gastro-intestinal ulcer, perforation or bleeding
- Surgery of the gastro-intestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy), neurological disorders, or psychiatric disorders
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 |
|---|---|---|
| Aggrenox | Drug | Aggrenox |
| Dipyridamole | Drug | dipyridamole+aspirin |
| Aspirin | Drug | dipyridamole+aspirin |
| Lansoprazole | Drug | Aggrenox, dipyridamole+aspirin |
Primary outcome
area under the concentration time curve (AUC0-12)
Time frame: up to 12 hours
7 secondary outcomes
area under the concentration time curve 0-48 hours (AUC0-48)
Time frame: up to 48 hours
area under the concentration time curve extrapolated to infinity (AUC0-inf)
Time frame: up to 3 days
maximum observed plasma concentration (Cmax)
Time frame: up to 3 days
time to maximum observed plasma concentration (Tmax)
Time frame: up to 3 days
terminal half life (t1/2)
Time frame: up to 3 days
number of subjects with adverse events
Time frame: up to 3 weeks
number of subjects with clinically significant changes in laboratory findings
Time frame: up to 17 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 29 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aggrenox, Dipyridamole and Aspirin in people with Healthy, run by Boehringer Ingelheim.
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 23 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 29 Sep 2014. 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. 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?
area under the concentration time curve (AUC0-12) (time frame: up to 12 hours). 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 29 Sep 2014.