Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01303445 · ClinicalTrials.gov registry record · Phase 1
Drug-drug Interaction Study of Aggrenox and Omeprazole in Normal Volunteers
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT01303445: Completed Phase 1 study, sponsored by Boehringer Ingelheim.
NCT01303445 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01303445, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study 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 hours at steady state.
Primary Outcome
Maximum measured concentration of dipyridamole in plasma
Interventions
- DRUG Aggrenox alone
- DRUG Aggrenox and omeprazole
- DRUG Omeprazole alone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-03 |
| Phase | Phase 1 |
What the finished NCT01303445 record still lists
NCT01303445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Aggrenox alone is the first listed.
NCT01303445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01303445 about?
NCT01303445 is a clinical study titled "Drug-drug Interaction Study of Aggrenox and Omeprazole in Normal Volunteers". 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 admin...
What is the current status of trial NCT01303445?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2011-03.
What interventions are being tested in trial NCT01303445?
The interventions under investigation include: Aggrenox alone (DRUG), Aggrenox and omeprazole (DRUG), Omeprazole alone (DRUG).
Who is sponsoring clinical trial NCT01303445?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01303445's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia