Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 60 of 602 for:    ASPIRIN AND clopidogrel

An Interaction Study to Evaluate the Effect of Esomeprazole/Acetylsalicylic Acid on the Metabolism and Effect of Clopidogrel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01210339
Recruitment Status : Completed
First Posted : September 28, 2010
Last Update Posted : October 7, 2011
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The primary purpose of this study is to assess whether esomeprazole 20 mg/Acetyl Salicylic Acid (ASA) 81 mg affect the metabolism of clopidogrel.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Clopidogrel Drug: Esomeprazole/ASA Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-label, Randomized, Single-center, 2-way Cross-over Interaction Study, Evaluating the Effect of Esomeprazole 20 mg/Acetylsalicylic Acid 81 mg on the Pharmacodynamics and the Pharmacokinetics of Clopidogrel on Days 1 and 9 in Healthy Volunteers
Study Start Date : November 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Treatment A (Clopidogrel 9 days), at least 14 days wash-out, Treatment B (Clopidogrel 4 days followed by Clopidogrel + Esomeprazole/ASA 5 days)
Drug: Clopidogrel
Clopidogrel

Drug: Esomeprazole/ASA
20 mg/81 mg once daily for five days (Day 5-9)
Other Name: Axanum

Experimental: 2
Treatment B (Clopidogrel 4 days followed by Clopidogrel + Esomeprazole/ASA 5 days), at least 14 days wash-out, Treatment A (Clopidogrel 9 days)
Drug: Clopidogrel
Clopidogrel

Drug: Esomeprazole/ASA
20 mg/81 mg once daily for five days (Day 5-9)
Other Name: Axanum




Primary Outcome Measures :
  1. The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacodynamics of clopidogrel by assessing maximal inhibition of platelet aggregation after 9 days of clopidogrel treatment relative to baseline [ Time Frame: Pharmacodynamic sampling will be done before treatment period 1. ]
  2. The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacodynamics of clopidogrel by assessing maximal inhibition of platelet aggregation after 9 days of clopidogrel treatment relative to baseline [ Time Frame: Pharmacodynamic sampling will be done after treatment period 1 ]
  3. The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacodynamics of clopidogrel by assessing maximal inhibition of platelet aggregation after 9 days of clopidogrel treatment relative to baseline [ Time Frame: Pharmacodynamic sampling will be done before treatment period 2. ]
  4. The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacodynamics of clopidogrel by assessing maximal inhibition of platelet aggregation after 9 days of clopidogrel treatment relative to baseline [ Time Frame: Pharmacodynamic sampling will be done after treatment period 2. ]

Secondary Outcome Measures :
  1. The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacokinetics of the active metabolite of clopidogrel by assessing Area Under Curve (AUC) and Cmax.after 9 days of clopidogrel treatment [ Time Frame: Pharmacokinetic sampling will be done at the end of treatment period 1 and 2 (Day 9). ]
  2. The safety and tolerability of clopidogrel alone and in combination with esomeprazole/ acetylsalicylic acid [ Time Frame: Safety will be monitored continuously. Adverse events will be collected from the first administration of Investigational Product (IP) throughout the study until the follow-up visit (on average) 7-10 days after last dose. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male (aged between 18 and 45 years inclusive) or female (aged between 18 and 55 years inclusive) healthy volunteers
  • Female healthy volunteers must be of non-childbearing potential or be of childbearing potential, be non-lactating and have a negative pregnancy test during the pre-entry visit and be using 1 clinically accepted method of contraception
  • Have a body mass index between 19 and 30 kg/m2 inclusive
  • No clinically significant abnormal findings at the physical examination as judged by the investigator

Exclusion Criteria:

  • Any clinically significant abnormalities in laboratory screening results as judged by investigator
  • Platelet count <150 x 10^9/L on Day -1 or any other conditions that would increase the risk of bleeding
  • Previous bone marrow transplant
  • Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210339


Locations
Layout table for location information
Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Layout table for investigator information
Study Director: Peter Nagy, MD AstraZeneca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01210339     History of Changes
Other Study ID Numbers: D961FC00010
First Posted: September 28, 2010    Key Record Dates
Last Update Posted: October 7, 2011
Last Verified: October 2011

Keywords provided by AstraZeneca:
phase 1
cross-over
drug-drug Interaction
esomeprazole
acetylsalicylic acid
clopidogrel
healthy volunteers
cardiovascular disease
patients with acid associated gastrointestinal symptoms

Additional relevant MeSH terms:
Layout table for MeSH terms
Clopidogrel
Aspirin
Esomeprazole
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cyclooxygenase Inhibitors
Antipyretics