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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

The purpose of the study is to determine the drug characteristics of Ticagrelor, and to determine if 4 weeks treatment will reduce the blood clotting.

An asian study to assess the properties and profile of ticagrelor in Patients with Stable Coronary Artery Disease

Research Site

A Randomised, Double-Blind, Parallel Group, Asian, Multicenter Study, to Assess Pharmacokinetic and Pharmacodynamic Profile of 2 Doses of Ticagrelor on Top of Low Dose Acetyl Salicylic Acid (ASA) Therapy on Platelet Aggregation in Japanese and Asian Patients with Stable Coronary Artery Disease

Final extent IPA from pre-dose baseline was calculated using the following formula for Adenosine Diphosphate (ADP)-induced platelet aggregation:
Percentage Inhibition = 100% x (PAs - PA) / (PAs) 
Platelet Aggregation (PA) was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit.

Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:
Percentage Inhibition = 100% x (PAs - PA) / (PAs)
PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit.

Age Continuous

Gender, Male/Female

Ethnicity, Customized

Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan

Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients

IPA final extent at 4 hours post dose on Week 4 in Japanese patients

IPA final extent at 8 hours post dose on Week 4 in Japanese patients

IPA final extent at 12 hours post dose on Week 4 in Japanese patients

IPA final extent at 24 hours post dose on Week 4 in Japanese patients

Only Japanese participants who had IPA data at Week 4 were considered in this analysis

AZD6140 (Cmax) at Week 4

Area under the plasma concentration curve of AZD6140 from time zero to dosing interval

In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.

AZD6140 (AUC0-tau) at Week 4

Time to reach peak or maximum concentration of AZD6140 following AZD6140 administration

AZD6140 (tmax) at Week 4

Maximum plasma concentration of AZD6140 drug metabolite AR-C124910XX

AR-C124910XX (Cmax) at Week 4

Area under the plasma concentration curve of AZD6140 drug metabolite AR-C124910XX from time zero to dosing interval

AR-C124910XX (AUC0-tau) at Week 4

Time to reach peak or maximum concentration of AZD6140 drug metabolite AR-C124910XX following AZD6140 administration

Arms	Assigned Interventions
Experimental: AZD6140 45 mg bd	Drug: ticagrelor Drug oral treatment
Experimental: AZD6140 90 mg bd	Drug: ticagrelor Drug oral treatment
Active Comparator: Clopidogrel 75 mg od	Drug: clopidogrel Drug oral treatment

An asian study to assess the properties and profile of ticagrelor in Patients with Stable Coronary Artery Disease

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=374&filename=CSR-D5130C00065.pdf

CSR-D5130C00065.pdf

D5130C00065_CSP_redacted_17_Oct_2013

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator