NCT02251184

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_4 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2000

Completed
13.9 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2014

Completed
Last Updated

September 29, 2014

Status Verified

September 1, 2014

Enrollment Period

1 month

First QC Date

September 25, 2014

Last Update Submit

September 25, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • area under the concentration time curve (AUC0-12)

    up to 12 hours

Secondary Outcomes (7)

  • area under the concentration time curve 0-48 hours (AUC0-48)

    up to 48 hours

  • area under the concentration time curve extrapolated to infinity (AUC0-inf)

    up to 3 days

  • maximum observed plasma concentration (Cmax)

    up to 3 days

  • time to maximum observed plasma concentration (Tmax)

    up to 3 days

  • terminal half life (t1/2)

    up to 3 days

  • +2 more secondary outcomes

Study Arms (2)

Aggrenox

EXPERIMENTAL

extended release

Drug: AggrenoxDrug: Lansoprazole

dipyridamole+aspirin

ACTIVE COMPARATOR

immediate release

Drug: DipyridamoleDrug: AspirinDrug: Lansoprazole

Interventions

AggrenoxDRUG
Aggrenox
DipyridamoleDRUG
dipyridamole+aspirin
AspirinDRUG
dipyridamole+aspirin
LansoprazoleDRUG
Aggrenoxdipyridamole+aspirin

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Aspirin, Dipyridamole Drug CombinationDipyridamoleAspirinLansoprazole

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsPyridinesBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2014

First Posted

September 29, 2014

Study Start

October 1, 2000

Primary Completion

November 1, 2000

Last Updated

September 29, 2014

Record last verified: 2014-09