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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
Up to 36 patients will be randomized in order to ensure 10 patients per treatment are evaluable.Ticagrelor will be supplied as 45 mg, 60mg, and 90mg tablets. Following an 8 hour fast on single dose on Day 1 and Day 7; on multiple doses from Day 3 to Day 6. Prior to the first dose of study drug there will be a screening period of maximum of 19 days. Patients will report to the clinical pharmacology unit (CPU) on Day -2 and will remain confined there until completion of study procedures on Day 7, the patients will be discharged on Day 8. In addition, patients will return to the CPU for a follow up visit 2 to 5 days after the last dose. Each patients participation, including the screening period, will take approximately 33 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor 45mg | Experimental | 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. |
|
| Ticagrelor 60mg | Experimental | 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. |
|
| Ticagrelor 90mg | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor) | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| IPA on Day 1 | 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). Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA). | Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1 |
| IPA on Day 7 | 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). Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA). | Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in PRU on Day 1 | Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA. | Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1 |
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Inclusion Criteria:
Provision of signed and dated written informed consent prior to any study specific procedures.
Female or male Chinese (as defined by Chinese Regulatory) patients aged 18 years or older with suitable veins for cannulations or repeated venipunctures.
Documented stable coronary heart disease (CHD) fulfilling all of the following, and taking 75-100 mg ASA daily treatment:
Diagnosed stable angina pectoris per the guidance of Chinese Society of Cardiology published in 2007, patients with angina severity classified as I and II of Canadian Cardiovascular Society grading of angina pectoris.
Female patients without pregnant potential
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haiyan Li, PhD | The 3rd Hospital of Peking University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | China |
22 participants did not meet includion/exclusion criteria. 2 participants withdrawed from study due to subject decision.1 participant withdrawed due to other reason. 36 participants were randomized and received study medication.
The first patient was recruited on February 27th 2014 and the last patient's informed consent was obtained on Oct 24th 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | IPA on Day 1 | 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). Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA). | All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug). | Posted | Mean | Standard Deviation | % IPA | Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinea pedis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rong Fu | Pharmaceutical Product Development, LLC. | 86-021-80135112 | rong.fu@ppdi.com |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Pharmacokinetics Parameters of Ticagrelor on Day 7(1) | Pharmacokinetics parameters of Ticagrelor on Day 7---Cmax | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7 |
| Safety---Vital Signs Over Time---Blood Pressure | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Vital signs (seated blood pressure [BP]) | Baseline, Day 1 to Day 7 and 2 to 5 days after last dose |
| Percent Change From Baseline in PRU on Day 7 | Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA. | Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7 |
| TIPA(Max)---Day 1 | The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA. | Day 1 |
| TIPA(Max)---Day 7 | The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA. | Day 7 |
| AUEC(Final Extent) on Day 1 | The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA. | IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1 |
| AUEC(Final Extent) on Day 7 | The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA. | IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7 |
| Pharmacokinetics Parameters of Ticagrelor on Day 1(3) | The pharmacokinetics parameter of ticagrelor on Day 1---tmax and t1/2 | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1 |
| Pharmacokinetics Parameters of Ticagrelor on Day 1(2) | The pharmacokinetics parameters of Ticagrelor on Day 1---AUC(0-inf), AUC(0-12h) and AUC(0-t). | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1 |
| Pharmacokinetics Parameters of Ticagrelor on Day 7(2) | The pharmacokinetics parameters of ticagrelor on Day 7---tmax | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7 |
| Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(1) | Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---Cmax | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1 |
| Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(3) | Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1: tmax and t1/2 | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1 |
| Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(1) | Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Cmax | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7 |
| Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(4) | Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 7---tmax | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7 |
| Pharmacokinetics Parameters of Metabolite : Parent on Day 1--Cmax | To determine Cmax ratio for the metabolite to that of the parent compound on Day 1 | Day 1 |
| Pharmacokinetics Parameters of Metabolite : Parent on Day 7---Cmax | To determine Cmax ratio of metabolite to that of the parent compound on Day 7 | Day 7 |
| Safety---Physical Examination, Summary of Abnormalities | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Physical examination | 2 to 5 days after last dose |
| Safety---Hematology Laboratory Variables Over Time---hematocrit | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---hematocrit | 2 to 5 days after last dose |
| Safety---All Allowed Concomitant Medications During Study Treatment | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Concomitant medications | All allowed concomitant medications during study treatment(up to 2-5 days after last dose), includes medications that began prior to randomization but were ongoing after randomization. |
| Safety---Causally Related Adverse Events by System Organ Class and Preferred Term | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Assessment of adverse events | Includes adverse events with an onset date on or after the date of first dose and up to and including the last study visit (up to 2-5 days after last dose). |
| Pharmacokinetics Parameters of Ticagrelor on Day 1(1) | The pharmacokinetics parameters of Ticagrelor on Day 1---Cmax | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1 |
| Pharmacokinetics Parameters of Ticagrelor on Day 7(3) | Pharmacokinetics parameters of Ticagrelor on Day 7---AUC(0-12h) | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7 |
| Pharmacokinetics Parameters of Ticagrelor on Day 7(4) | Pharmacokinetics parameters of Ticagrelor on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h)) | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7 |
| Safety---Vital Signs Over Time---Height | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Vital signs (Height) | Baseline |
| Safety---Vital Signs Over Time---Weight | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Vital signs (Weight) | Baseline |
| Safety---Vital Signs Over Time---Pulse Rate | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Vital signs (Pulse Rate) | Baseline, Day 1 to Day 7 and 2 to 5 days after last dose |
| Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(2) | Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---AUC(0-12h), AUC(0-t) and AUC(0-inf) | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1 |
| Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(2) | Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---AUC(0-12h) | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7 |
| Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(3) | Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h)) | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7 |
| Safety---Hematology Laboratory Variables Over Time---Erythrocytes | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---Erythrocytes | 2 to 5 days after last dose |
| Safety---Hematology Laboratory Variables Over Time---Hemoglobin | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---Hemoglobin | 2 to 5 days after last dose |
| Safety---Hematology Laboratory Variables Over Time---Leukocytes | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---Leukocytes | 2 to 5 days after last dose |
| Safety---Hematology Laboratory Variables Over Time---Platelets | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---Platelets | 2 to 5 days after last dose |
| Safety---Clinical Chemistry Variables Over Time---Glucose | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Glucose | 2 to 5 days after last dose |
| Safety---Clinical Chemistry Variables Over Time---Alanine Aminotransferase | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Alanine Aminotransferase | 2 to 5 days after last dose |
| Safety---Clinical Chemistry Variables Over Time---Aspartate Aminotransferase | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Aspartate Aminotransferase | 2 to 5 days after last dose |
| Safety---Clinical Chemistry Variables Over Time---Alkaline Phosphatase | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Alkaline Phosphatase | 2 to 5 days after last dose |
| Safety---Clinical Chemistry Variables Over Time---Creatinine | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Creatinine | 2 to 5 days after last dose |
| Safety---Clinical Chemistry Variables Over Time---Total Bilirubin | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Total Bilirubin | 2 to 5 days after last dose |
| Safety---Clinical Chemistry Variables Over Time---Sodium | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Sodium | 2 to 5 days after last dose |
| Safety---Clinical Chemistry Variables Over Time---Potassium | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Potassium | 2 to 5 days after last dose |
| Safety---Clinical Chemistry Variables Over Time---Chloride | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Chloride | 2 to 5 days after last dose |
| Safety---Clinical Chemistry Variables Over Time---Phosphate | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Phosphate | 2 to 5 days after last dose |
| Safety---Clinical Chemistry Variables Over Time---Albumin | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Albumin | 2 to 5 days after last dose |
| Safety---Clinical Chemistry Variables Over Time---Protein | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Protein | 2 to 5 days after last dose |
| Safety---Clinical Chemistry Variables Over Time---Blood Urea Nitrogen | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Blood Urea Nitrogen | 2 to 5 days after last dose |
| Safety---Clinical Chemistry Variables Over Time---Bicarbonate | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Bicarbonate | 2 to 5 days after last dose |
| Pharmacokinetics Parameters of Metabolite : Parent on Day 1--AUC(0-inf) | To determine AUC(0-inf) ratio for the metabolite to that of the parent compound on Day 1 | Day 1 |
| Pharmacokinetics Parameters of Metabolite : Parent on Day 7---AUC(0-12h) | To determine AUC(0-12h) ratio of metabolite to that of the parent compound on Day 7. | Day 7 |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| OG001 | 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. |
| OG002 | 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. |
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| Secondary | Percent Change From Baseline in PRU on Day 1 | Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA. | All randomized patients who received at least one dose of investigational product with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (e.g., non-compliance with study drug) will be included in the PD analysis set. | Posted | Mean | Standard Deviation | % change from baseline | Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1 |
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| Secondary | Pharmacokinetics Parameters of Ticagrelor on Day 7(1) | Pharmacokinetics parameters of Ticagrelor on Day 7---Cmax | All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7 |
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| Secondary | Safety---Vital Signs Over Time---Blood Pressure | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Vital signs (seated blood pressure [BP]) | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | mmHg | Baseline, Day 1 to Day 7 and 2 to 5 days after last dose |
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| Primary | IPA on Day 7 | 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). Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA). | All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug). | Posted | Mean | Standard Deviation | % IPA | Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7 |
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| Secondary | Percent Change From Baseline in PRU on Day 7 | Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA. | All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug). | Posted | Mean | Standard Deviation | % change from baseline | Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7 |
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| Secondary | TIPA(Max)---Day 1 | The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA. | All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug). | Posted | Median | Inter-Quartile Range | hour | Day 1 |
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| Secondary | TIPA(Max)---Day 7 | The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA. | All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug). | Posted | Median | Inter-Quartile Range | hour | Day 7 |
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| Secondary | AUEC(Final Extent) on Day 1 | The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA. | All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug). | Posted | Mean | Standard Deviation | %*h | IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1 |
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| Secondary | AUEC(Final Extent) on Day 7 | The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA. | All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug). | Posted | Mean | Standard Deviation | %*h | IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7 |
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| Secondary | Pharmacokinetics Parameters of Ticagrelor on Day 1(3) | The pharmacokinetics parameter of ticagrelor on Day 1---tmax and t1/2 | All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set. | Posted | Median | Full Range | hour | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1 |
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| Secondary | Pharmacokinetics Parameters of Ticagrelor on Day 1(2) | The pharmacokinetics parameters of Ticagrelor on Day 1---AUC(0-inf), AUC(0-12h) and AUC(0-t). | All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1 |
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| Secondary | Pharmacokinetics Parameters of Ticagrelor on Day 7(2) | The pharmacokinetics parameters of ticagrelor on Day 7---tmax | All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set. | Posted | Median | Full Range | hour | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7 |
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| Secondary | Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(1) | Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---Cmax | All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1 |
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| Secondary | Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(3) | Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1: tmax and t1/2 | All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set. | Posted | Median | Full Range | hour | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1 |
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| Secondary | Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(1) | Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Cmax | All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7 |
|
|
|
| Secondary | Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(4) | Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 7---tmax | All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set. | Posted | Median | Full Range | hour | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7 |
|
|
|
| Secondary | Pharmacokinetics Parameters of Metabolite : Parent on Day 1--Cmax | To determine Cmax ratio for the metabolite to that of the parent compound on Day 1 | All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set. | Posted | Mean | Standard Deviation | ratio | Day 1 |
|
|
|
| Secondary | Pharmacokinetics Parameters of Metabolite : Parent on Day 7---Cmax | To determine Cmax ratio of metabolite to that of the parent compound on Day 7 | All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set. | Posted | Mean | Standard Deviation | ratio | Day 7 |
|
|
|
| Secondary | Safety---Physical Examination, Summary of Abnormalities | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Physical examination | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Number | Participants | 2 to 5 days after last dose |
|
|
|
| Secondary | Safety---Hematology Laboratory Variables Over Time---hematocrit | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---hematocrit | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | ratio | 2 to 5 days after last dose |
|
|
|
| Secondary | Safety---All Allowed Concomitant Medications During Study Treatment | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Concomitant medications | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Number | Participants | All allowed concomitant medications during study treatment(up to 2-5 days after last dose), includes medications that began prior to randomization but were ongoing after randomization. |
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|
|
| Secondary | Safety---Causally Related Adverse Events by System Organ Class and Preferred Term | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Assessment of adverse events | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Number | Participants | Includes adverse events with an onset date on or after the date of first dose and up to and including the last study visit (up to 2-5 days after last dose). |
|
|
|
| Secondary | Pharmacokinetics Parameters of Ticagrelor on Day 1(1) | The pharmacokinetics parameters of Ticagrelor on Day 1---Cmax | All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1 |
|
|
|
| Secondary | Pharmacokinetics Parameters of Ticagrelor on Day 7(3) | Pharmacokinetics parameters of Ticagrelor on Day 7---AUC(0-12h) | All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7 |
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|
|
| Secondary | Pharmacokinetics Parameters of Ticagrelor on Day 7(4) | Pharmacokinetics parameters of Ticagrelor on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h)) | All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7 |
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|
|
| Secondary | Safety---Vital Signs Over Time---Height | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Vital signs (Height) | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | cm | Baseline |
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|
|
| Secondary | Safety---Vital Signs Over Time---Weight | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Vital signs (Weight) | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | kg | Baseline |
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|
|
| Secondary | Safety---Vital Signs Over Time---Pulse Rate | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Vital signs (Pulse Rate) | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | BEATS/MIN | Baseline, Day 1 to Day 7 and 2 to 5 days after last dose |
|
|
|
| Secondary | Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(2) | Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---AUC(0-12h), AUC(0-t) and AUC(0-inf) | All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1 |
|
|
|
| Secondary | Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(2) | Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---AUC(0-12h) | All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7 |
|
|
|
| Secondary | Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(3) | Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h)) | All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7 |
|
|
|
| Secondary | Safety---Hematology Laboratory Variables Over Time---Erythrocytes | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---Erythrocytes | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | 10^12/L | 2 to 5 days after last dose |
|
|
|
| Secondary | Safety---Hematology Laboratory Variables Over Time---Hemoglobin | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---Hemoglobin | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | g/L | 2 to 5 days after last dose |
|
|
|
| Secondary | Safety---Hematology Laboratory Variables Over Time---Leukocytes | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---Leukocytes | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | 10^9/L | 2 to 5 days after last dose |
|
|
|
| Secondary | Safety---Hematology Laboratory Variables Over Time---Platelets | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Haematology---Platelets | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | 10^9/L | 2 to 5 days after last dose |
|
|
|
| Secondary | Safety---Clinical Chemistry Variables Over Time---Glucose | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Glucose | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | mmol/L | 2 to 5 days after last dose |
|
|
|
| Secondary | Safety---Clinical Chemistry Variables Over Time---Alanine Aminotransferase | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Alanine Aminotransferase | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | ukat/L | 2 to 5 days after last dose |
|
|
|
| Secondary | Safety---Clinical Chemistry Variables Over Time---Aspartate Aminotransferase | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Aspartate Aminotransferase | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | ukat/L | 2 to 5 days after last dose |
|
|
|
| Secondary | Safety---Clinical Chemistry Variables Over Time---Alkaline Phosphatase | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Alkaline Phosphatase | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | ukat/L | 2 to 5 days after last dose |
|
|
|
| Secondary | Safety---Clinical Chemistry Variables Over Time---Creatinine | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Creatinine | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | umol/L | 2 to 5 days after last dose |
|
|
|
| Secondary | Safety---Clinical Chemistry Variables Over Time---Total Bilirubin | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Total Bilirubin | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | umol/L | 2 to 5 days after last dose |
|
|
|
| Secondary | Safety---Clinical Chemistry Variables Over Time---Sodium | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Sodium | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | mmol/L | 2 to 5 days after last dose |
|
|
|
| Secondary | Safety---Clinical Chemistry Variables Over Time---Potassium | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Potassium | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | mmol/L | 2 to 5 days after last dose |
|
|
|
| Secondary | Safety---Clinical Chemistry Variables Over Time---Chloride | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Chloride | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | mmol/L | 2 to 5 days after last dose |
|
|
|
| Secondary | Safety---Clinical Chemistry Variables Over Time---Phosphate | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Phosphate | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | mmol/L | 2 to 5 days after last dose |
|
|
|
| Secondary | Safety---Clinical Chemistry Variables Over Time---Albumin | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Albumin | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | g/L | 2 to 5 days after last dose |
|
|
|
| Secondary | Safety---Clinical Chemistry Variables Over Time---Protein | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Protein | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | g/L | 2 to 5 days after last dose |
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|
|
| Secondary | Safety---Clinical Chemistry Variables Over Time---Blood Urea Nitrogen | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Blood Urea Nitrogen | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | mmol/L | 2 to 5 days after last dose |
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|
|
| Secondary | Safety---Clinical Chemistry Variables Over Time---Bicarbonate | The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA. Safety will be assessed by: • Clinical Chemistry---Bicarbonate | All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set. | Posted | Mean | Standard Deviation | mmol/L | 2 to 5 days after last dose |
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|
|
| Secondary | Pharmacokinetics Parameters of Metabolite : Parent on Day 1--AUC(0-inf) | To determine AUC(0-inf) ratio for the metabolite to that of the parent compound on Day 1 | All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set. | Posted | Mean | Standard Deviation | ratio | Day 1 |
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| Secondary | Pharmacokinetics Parameters of Metabolite : Parent on Day 7---AUC(0-12h) | To determine AUC(0-12h) ratio of metabolite to that of the parent compound on Day 7. | All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set. | Posted | Mean | Standard Deviation | ratio | Day 7 |
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|
|
| 0 |
| 12 |
| 4 |
| 12 |
| EG001 | 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. | 0 | 12 | 4 | 12 |
| EG002 | 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. | 0 | 12 | 5 | 12 |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Cardiac discomfort | Cardiac disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Occult blood positive | Investigations | MedDRA 17.1 | Non-systematic Assessment |
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| Electrocardiogram ST-T change | Investigations | MedDRA 17.1 | Non-systematic Assessment |
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| Frequent bowel movements | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
Institution and Principal Investigator may use the Study results (data generated at the site) and shall not publish or present any such results until the earlier of (i) the date of the first Study results publication and (ii) the end of the eighteen (18) month period following the completion, or early termination, of the Study at all participating sites.
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
|
| 2 hours after dose intake |
|
| 3 hours after dose intake |
|
| 6 hours after dose intake |
|
| 12 hours after dose intake |
|
| 24 hours after dose intake |
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| 36 hours after dose intake |
|
| 48hours after dose intake |
|
|
| Diastolic Blood Pressure-Day 2 |
|
| Diastolic Blood Pressure-Day 3 |
|
| Diastolic Blood Pressure-Day 4 |
|
| Diastolic Blood Pressure-Day 5 |
|
| Diastolic Blood Pressure-Day 6 |
|
| Diastolic Blood Pressure-Day 7 |
|
| Diastolic Blood Pressure-2-5 days after last Dose |
|
| Systolic Blood Pressure (mmHg)-Baseline |
|
| Systolic Blood Pressure-Day 1 |
|
| Systolic Blood Pressure-Day 2 |
|
| Systolic Blood Pressure-Day 3 |
|
| Systolic Blood Pressure-Day 4 |
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| Systolic Blood Pressure-Day 5 |
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| Systolic Blood Pressure-Day 6 |
|
| Systolic Blood Pressure-Day 7 |
|
| Systolic Blood Pressure-2-5 days after last Dose |
|
|
| 1 hour after dose intake |
|
| 2 hours after dose intake |
|
| 3 hours after dose intake |
|
| 6 hours after dose intake |
|
| 12 hours after dose intake |
|
|
| 2 hours after dose intake |
|
| 3 hours after dose intake |
|
| 6 hours after dose intake |
|
| 12 hours after dose intake |
|
| t½ |
|
|
| AUC(0-12h) |
|
| t½ |
|
|
| Cardiovascular |
|
| General appearance |
|
| Head and neck |
|
| Lymph nodes |
|
| Musculoskeletal / Extremities |
|
| Neurological |
|
| Respiratory |
|
| Skin |
|
| Thyroid |
|
|
| ATORVASTATIN |
|
| SIMVASTATIN |
|
| ROSUVASTATIN |
|
| Beta blocking agents, selective |
|
| METOPROLOL |
|
| BISOPROLOL |
|
| ACE inhibitors, plain |
|
| PERINDOPRIL |
|
| FOSINOPRIL |
|
| ENALAPRIL |
|
| BENAZEPRIL |
|
| IMIDAPRIL |
|
| Dihydropyridine derivatives |
|
| AMLODIPINE |
|
| NIFEDIPINE |
|
| Other cardiac preparations |
|
| TRIMETAZIDINE |
|
| TRIMETAZIDINE HYDROCHLORIDE |
|
| Biguanides |
|
| METFORMIN |
|
| METFORMIN HYDROCHLORIDE |
|
| Organic nitrates |
|
| ISOSORBIDE MONONITRATE |
|
| Angiotensin II antagonists, plain |
|
| IRBESARTAN |
|
| LOSARTAN |
|
| TELMISARTAN |
|
| Alpha glucosidase inhibitors |
|
| ACARBOSE |
|
| Insulins and analogues for injection, fast-acting |
|
| INSULIN |
|
| INSULIN HUMAN |
|
| Enzymes |
|
| KALLIDINOGENASE |
|
| Folic acid and derivatives |
|
| FOLIC ACID |
|
| Alpha and beta blocking agents |
|
| CARVEDILOL |
|
| Other therapeutic products |
|
| CHINESE TRADITIONAL MEDICINE NOS |
|
| HERBAL NOS |
|
| Preparations inhibiting uric acid production |
|
| ALLOPURINOL |
|
| Sulfonamides, urea derivatives |
|
| GLIMEPIRIDE |
|
| GLIQUIDONE |
|
| ANTIHYPERTENSIVES |
|
| ANTIHYPERTENSIVES |
|
| Aldose reductase inhibitors |
|
| EPALRESTAT |
|
| Angiotensin II antagonists and diuretics |
|
| HYDROCHLOROTHIAZIDE+ LOSARTAN |
|
| Antidepressants in combination with psycholeptics |
|
| FLUPENTIXOL+MELITRACEN |
|
| Benzodiazepine derivatives |
|
| ESTAZOLAM |
|
| Benzothiazepine derivatives |
|
| DILTIAZEM |
|
| Comb/complexes aluminium, calcium, magnesium comps |
|
| HYDROTALCITE |
|
| Fibrates |
|
| FENOFIBRATE |
|
| Insulins and analogues for inj,intermediate-acting |
|
| HUMULIN 70/30 |
|
| Insulins/analogues for inj,int/long-act+fast-actin |
|
| INSULIN ASPART |
|
| Nicotinic acid and derivatives |
|
| ACIPIMOX |
|
| Other antifungals for topical use |
|
| TERBINAFINE HYDROCHLORIDE |
|
| Other drugs for peptic ulcer and GORD |
|
| GEFARNATE |
|
| Other vasodilators used in cardiac diseases |
|
| NICORANDIL |
|
| Thiazolidinediones |
|
| ROSIGLITAZONE |
|
|
| Dyspnoea |
|
| Haemoptysis |
|
| Gastrointestinal disorders |
|
| Diarrhoea |
|
| Investigations |
|
| Occult blood positive |
|
|
| Pulse Rate (BEATS/MIN)- Day 2 |
|
| Pulse Rate (BEATS/MIN)- Day 3 |
|
| Pulse Rate (BEATS/MIN)- Day 4 |
|
| Pulse Rate (BEATS/MIN)- Day 5 |
|
| Pulse Rate (BEATS/MIN)- Day 6 |
|
| Pulse Rate (BEATS/MIN)- Day 7 |
|
| Pulse Rate(BEATS/MIN)- 2 to 5 days after last dose |
|
|
| AUC(0-12h) |
|