Trial · NCT02564718
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1 | 30 minutes to 1.5 hours post-dose; 2 to 4 hours post-dose (bid dosing) and 30 minutes to 3 hours post-dose; 7 to 8 hours post-dose on Day 1 (tid dosing) | Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated. |
| Primary | Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 3 | 2 to 8 hours post-dose (bid dosing) and 30 minutes to 3 hours post-dose; 7 to 8 hours post-dose on Day 3 (tid dosing) | Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated. |
| Primary | Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 8 | 10 to 16 hours post-dose on Day 8 (bid dosing) | Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated. |
| Primary | Change From Baseline in Prothrombin Time at Day 1 | 10-16 hours post-dose on Day 8 (baseline), 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing) | Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade. |
| Primary | Change From Baseline in Prothrombin Time at Day 3 | 10-16 hours post-dose on Day 8 (baseline), 2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing) | Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade. |
| Primary | Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 1 | 10-16 hours post-dose on Day 8 (baseline), 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing) | The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway and is sensitive for deficiencies of factors I, II, V, VIII, IX, X, XI and XII. |
| Primary | Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 3 | 10-16 hours post-dose on Day 8 (baseline), 2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing) | The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway and is sensitive for deficiencies of factors I, II, V, VIII, IX, X, XI and XII. |
| Primary | Anti-factor Xa Activity (Anti-Xa) Values at Day 1 | 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing) | The individual anti-Factor Xa activity was determined ex-vivo using a photometric method. |
| Primary | Anti-factor Xa Activity (Anti-Xa) Values at Day 3 | 2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing) | The individual anti-Factor Xa activity was determined ex-vivo using a photometric method. |
| Primary | Anti-factor Xa Activity (Anti-Xa) Values at Day 8 | 10-16 hours post-dose on Day 8 (both bid and tid dosing) | The individual anti-Factor Xa activity was determined ex-vivo using a photometric method. |
| Secondary | Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events | From start of study drug administration until 30-day post study treatment period | Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and •associated with a fall in hemoglobin of 2 gram/deciliter (g/dL) or more, •leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or •occurring in a critical site, example: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or •contributing to death. Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with: •medical intervention, or •unscheduled contact (visit or telephone call) with a physician, or •cessation (temporary) of study treatment, or •discomfort for the child such as pain |
| Secondary | Number of Participants With Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging | From start of study drug administration until 30-day post study treatment period | Symptomatic recurrence of thromboembolism and asymptomatic deterioration was documented using the appropriate imaging test and confirmed by CIAC which was unaware of treatment assignment. Asymptomatic deterioration in thrombotic burden on repeat imaging, as assessed by the CIAC. Adjudication results were the basis for the final analyses. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02564718/registered