Clinical Trial Details
| Trial ID: | L0784 |
| Source ID: | NCT02022748 |
| Associated Drug: | Ticagrelor |
| Title: | Pharmacokinetics, Pharmacodynamics, and Safety Study of Ticagrelor in Hemodialysis Patients and Healthy Subjects |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02022748/results |
| Conditions: | Kidney Failure, Chronic |
| Interventions: | DRUG: ticagrelor|DRUG: ticagrelor|DRUG: ticagrelor |
| Outcome Measures: | Primary: Pharmacokinetic Parameter Cmax of Ticagrelor, 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose|Pharmacokinetic Parameter Cmax of AR-C124910XX, 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose|Pharmacokinetic Parameter AUC0-∞ (Area Under the Plasma Concentration-time Curve From Time Zero to Infinity) of Ticagrelor, 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose|Pharmacokinetic Parameter AUC0-∞ of AR-C124910XX, 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose | Secondary: Pharmacokinetic Parameter t1/2 of Ticagrelor, 3 days|Pharmacokinetic Parameter t1/2 of AR-C124910XX, 3 days |
| Sponsor/Collaborators: | Sponsor: AstraZeneca |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 27 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2013-12-29 |
| Completion Date: | 2016-05-09 |
| Results First Posted: | 2017-09-29 |
| Last Update Posted: | 2018-01-17 |
| Locations: | Research Site, Lakewood, Colorado, 80228, United States|Research Site, Minneapolis, Minnesota, 55404, United States |
| URL: | https://clinicaltrials.gov/show/NCT02022748 |
