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Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH

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ClinicalTrials.gov Identifier: NCT02251184
Recruitment Status : Completed
First Posted : September 29, 2014
Last Update Posted : September 29, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Aggrenox Drug: Dipyridamole Drug: Aspirin Drug: Lansoprazole Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : October 2000
Actual Primary Completion Date : November 2000

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aggrenox
extended release
Drug: Aggrenox
Drug: Lansoprazole
Active Comparator: dipyridamole+aspirin
immediate release
Drug: Dipyridamole
Drug: Aspirin
Drug: Lansoprazole



Primary Outcome Measures :
  1. area under the concentration time curve (AUC0-12) [ Time Frame: up to 12 hours ]

Secondary Outcome Measures :
  1. area under the concentration time curve 0-48 hours (AUC0-48) [ Time Frame: up to 48 hours ]
  2. area under the concentration time curve extrapolated to infinity (AUC0-inf) [ Time Frame: up to 3 days ]
  3. maximum observed plasma concentration (Cmax) [ Time Frame: up to 3 days ]
  4. time to maximum observed plasma concentration (Tmax) [ Time Frame: up to 3 days ]
  5. terminal half life (t1/2) [ Time Frame: up to 3 days ]
  6. number of subjects with adverse events [ Time Frame: up to 3 weeks ]
  7. number of subjects with clinically significant changes in laboratory findings [ Time Frame: up to 17 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02251184     History of Changes
Other Study ID Numbers: 9.146
First Posted: September 29, 2014    Key Record Dates
Last Update Posted: September 29, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
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Aspirin
Dipyridamole
Aspirin, Dipyridamole Drug Combination
Lansoprazole
Dexlansoprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Phosphodiesterase Inhibitors
Vasodilator Agents