Ticagrelor China Pharmacokinetic/Pharmacodynamic study
Study identifier:D5130C00086
ClinicalTrials.gov identifier:NCT02064985
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An Open Label, Single Centre, Randomised, Phase IV, Pharmacokinetic, Pharmacodynamic, and Safety Study to Evaluate Single and Multiple Doses of 45, 60, and 90 mg of Ticagrelor in Chinese Patients with Stable Coronary Heart Disease
Medical condition
stable coronary heart disease (CHD)
Phase
Phase 4
Healthy volunteers
No
Study drug
Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor)
Sex
All
Actual Enrollment
61
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Feb 2014
Primary Completion Date: 01 Nov 2014
Study Completion Date: 01 Nov 2014
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jun 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ticagrelor 45mg A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7. | Drug: Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor) To determine the Inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily). Other Name: "Brilinta"(Ticagrelor) |
| Experimental: Ticagrelor 60mg A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7. | Drug: Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor) To determine the Inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily). Other Name: "Brilinta"(Ticagrelor) |
| Experimental: Ticagrelor 90mg A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7. | Drug: Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor) To determine the Inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily). Other Name: "Brilinta"(Ticagrelor) |
Contacts
Investigators
Principal Investigator
Haiyan Li
The 3rd Hospital of Peking University
