HealthyPhase 1NCT01303445

Drug-drug Interaction Study of Aggrenox and Omeprazole in Normal Volunteers

A Phase 1 study testing Aggrenox alone, Aggrenox and omeprazole and Omeprazole alone in people with Healthy, run by Boehringer Ingelheim at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of the current study is to investigate if a drug-drug interaction occurs with the administration of omeprazole 80 mg q.d. at steady state on the pharmacokinetics of dipyridamole and the pharmacodynamics of ASA-induced platelet aggregation inhibition (components of Aggrenox®) when administered every 12… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Aggrenox alone, Aggrenox and omeprazole and Omeprazole alone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Mar 2011to Apr 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males and females according to the following criteria:
Based upon a complete medical history, including the physical examination, vital signs (blood pressure(BP), pulse rate (PR)), 12-lead ECG, clinical laboratory tests
BMI >18.5 and BMI <32 kg/m2 (Body Mass Index)

Who cannot join

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance in the opinion of the PI
Any evidence of a clinically relevant concomitant disease
Clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal, or hematologic (including a history of abnormal bruising) disorders in the opinion of the PI
Surgery of the gastrointestinal tract that might impair drug absorption
Clinically significant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts.

Show all 19Show fewer

Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to study drugs or its excipients, or reactions to related drugs [e.g., non-steroidal anti-inflammatory drugs])
Intake of drugs with a long half-life (¿24 hours) within one month, or less than 10 half lives of the respective drug, prior to study drug administration or during the trial
Use of drugs which might reasonably influence the results of the trial (including OTC antacids) based on the knowledge at the time of protocol preparation within 14 days prior to administration or during the trial
Participation in another trial with an investigational drug within two months prior to administration or during the trial
Tobacco use within the 90 days prior to check-in and throughout the study
Alcohol abuse within the past 2 years
Drug abuse within the past 2 years
Blood donation or other significant blood loss within 56 days (inclusive) prior to screening, or plasma donation within 7 days (inclusive) prior to study drug administration, or during the trial
Excessive physical activities (within one week prior to first drug administration or during the trial)
Any laboratory value outside the reference range that is of clinical relevance in the opinion of the PI; including positive virology, or urine drug screen, or positive fecal occult blood test
Inability to comply with dietary regimen of trial site
In the opinion of the investigator it would be in the best interest of the subject to be excluded from participation.

Trial locations and contacts

1 site in 1 country.

United States1 site

9.197.001 Boehringer Ingelheim Investigational Site
Tempe, Arizona

Other trials in United States

About this study

Official title: Drug-drug Interaction Study of the Effect of Omeprazole 80 mg q.d. at Steady State on the Pharmacokinetics and Pharmacodynamics of Aggrenox® Every 12 Hours at Steady State in Healthy Male and Female Volunteers (an Open-label, Randomised, Crossover Study)

Read the detailed description

Purpose:

Conditions: Healthy
Being tested: Aggrenox alone, Aggrenox and omeprazole, Omeprazole alone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aggrenox aloneDrug
Aggrenox 1 capsule twice daily for 7 days
Aggrenox and omeprazoleDrug
Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days
Aggrenox and omeprazoleDrug
Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days
Omeprazole aloneDrug
omeprazole 80 once daily for 7 days

Study groups in NCT01303445
Study group	Role	What they receive
Treatment A	Active comparator	Aggrenox alone Receives: Drug: Aggrenox alone
Treatment B	Experimental	Aggrenox and omeprazole Receives: Drug: Aggrenox and omeprazole
Treatment C	Active comparator	Omeprazole alone Receives: Drug: Omeprazole alone
Treatment D	Experimental	Aggrenox and omeprazole Receives: Drug: Aggrenox and omeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma Dipyridamole Maximum Concentration (Cmax)
Maximum measured concentration of dipyridamole in plasma
Measured: 7 days
Plasma Dipyridamole Area Under Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12)
Area under the concentration time curve of the analyte in plasma from 0 to 12 hours at steady state
Measured: 7 days
Inhibition of Platelet Aggregation at 4 Hours Post Dose (IPA4)
IPA4 equals the platelet aggregation measured 4 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).
Measured: 7 days

Secondary outcomes (3)

Plasma Dipyridamole Minimum Concentration (Cmin)
Minimum measured concentration of dipyridamole in plasma
Measured: 7 days
Inhibition of Platelet Aggregation at 12 Hours Post Dose (IPA12)
IPA12 equals the platelet aggregation measured 12 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).
Measured: 7 days
Percentage Peak-to-trough Fluctuation (%PTF)
PTF = 100*((Cmax-Cmin)/Cavg) where Cavg=(AUC0-12)/12.
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Apr 2011

First posted24 Feb 2011 (estimated)
Study startMar 2011
Primary completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 1
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01303445
Sponsor's protocol ID: 9.197
Status last verified: Jul 2012
First submitted: 23 Feb 2011
Last updated: 24 Dec 2013
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Drug-drug Interaction Study of the Effect of Omeprazole 80 mg q.d. at Steady State on the Pharmacokinetics and Pharmacodynamics of Aggrenox® Every 12 Hours at Steady State in Healthy Male and Female Volunteers (an Open-label, Randomised, Crossover Study)
ClinicalTrials.gov ID: NCT01303445
Acronym / sponsor ID: 9.197
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Apr 2011 (actual)
First posted: 24 Feb 2011 (estimated)
Results: Posted 24 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Purpose:

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Treatment A	Active comparator	Drug: Aggrenox aloneAggrenox alone
Treatment B	Experimental	Drug: Aggrenox and omeprazoleAggrenox and omeprazole
Treatment C	Active comparator	Drug: Omeprazole aloneOmeprazole alone
Treatment D	Experimental	Drug: Aggrenox and omeprazoleAggrenox and omeprazole

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy males and females according to the following criteria:
Based upon a complete medical history, including the physical examination, vital signs (blood pressure(BP), pulse rate (PR)), 12-lead ECG, clinical laboratory tests
BMI >18.5 and BMI <32 kg/m2 (Body Mass Index)

Key exclusion criteria (19 listed)

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance in the opinion of the PI
Any evidence of a clinically relevant concomitant disease
Clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal, or hematologic (including a history of abnormal bruising) disorders in the opinion of the PI
Surgery of the gastrointestinal tract that might impair drug absorption
Clinically significant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological 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 aloneAggrenox 1 capsule twice daily for 7 days	Drug	Treatment A
Aggrenox and omeprazoleAggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days	Drug	Treatment B
Aggrenox and omeprazoleAggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days	Drug	Treatment D
Omeprazole aloneomeprazole 80 once daily for 7 days	Drug	Treatment C

Primary outcome

Plasma Dipyridamole Maximum Concentration (Cmax)
Time frame: 7 days
Maximum measured concentration of dipyridamole in plasma
Plasma Dipyridamole Area Under Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12)
Time frame: 7 days
Area under the concentration time curve of the analyte in plasma from 0 to 12 hours at steady state
Inhibition of Platelet Aggregation at 4 Hours Post Dose (IPA4)
Time frame: 7 days
IPA4 equals the platelet aggregation measured 4 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).

3 secondary outcomes

Plasma Dipyridamole Minimum Concentration (Cmin)
Time frame: 7 days
Inhibition of Platelet Aggregation at 12 Hours Post Dose (IPA12)
Time frame: 7 days
Percentage Peak-to-trough Fluctuation (%PTF)
Time frame: 7 days

Results and safety

Results posted to the registry on 24 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ABCD Sequence	30	29
CDAB Sequence	30	30

Primary outcome: Plasma Dipyridamole Maximum Concentration (Cmax)

Time frame: 7 days. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram/milliliter

Measure	Aggrenox Alone BID n = 55	Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone n = 54	Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone n = 54	Omeprazole Alone QD n = 0
Value	2750 (30.4)	2550 (27.5)	2550 (29.1)	–

Aggrenox Alone BID vs Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone: Percent Mean Ratio: 92.03 (90% CI 86.95 to 97.40)
Aggrenox Alone BID vs Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone: Percent Mean Ratio: 92.30 (90% CI 87.76 to 97.08)

Population analysed: The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.

Primary outcome: Plasma Dipyridamole Area Under Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12)

Time frame: 7 days. Geometric mean (Geometric Coefficient of Variation). Unit: (nanogram/milliliter)*hours

Measure	Aggrenox Alone BID n = 55	Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone n = 53	Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone n = 54	Omeprazole Alone QD n = 0
Value	17100 (33.7)	16700 (28.4)	16500 (31.1)	–

Aggrenox Alone BID vs Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone: Percent Mean Ratio: 96.38 (90% CI 90.96 to 102.13)
Aggrenox Alone BID vs Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone: Percent Mean Ratio: 97.03 (95% CI 93.26 to 100.95)

Primary outcome: Inhibition of Platelet Aggregation at 4 Hours Post Dose (IPA4)

Time frame: 7 days. Mean (Standard Deviation). Unit: percent of baseline platelet aggregation

Measure	Aggrenox Alone BID n = 55	Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone n = 54	Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone n = 54	Omeprazole Alone QD n = 0
Value	97.89 (2.74)	96.34 (4.21)	97.02 (2.69)	–

Aggrenox Alone BID vs Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone: Percent Mean Ratio: 99.02 (90% CI 98.32 to 99.72)
Aggrenox Alone BID vs Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone: Percent Mean Ratio: 98.42 (90% CI 97.66 to 99.18)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aggrenox Alone BID	0 of 56 (0%)	41 of 56 (73.2%)	Not reported
Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone	0 of 55 (0%)	15 of 55 (27.3%)	Not reported
Omeprazole Alone QD	0 of 57 (0%)	17 of 57 (29.8%)	Not reported
Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone	0 of 57 (0%)	48 of 57 (84.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Related InfoLink 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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

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 Aggrenox alone, Aggrenox and omeprazole and Omeprazole alone in people with Healthy, run by Boehringer Ingelheim 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 3 inclusion and 19 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 24 Dec 2013. 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?

Yes. Results are posted in the registry (first posted 24 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Plasma Dipyridamole Maximum Concentration (Cmax) (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01303445.

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 24 Dec 2013.