Clinical trials: Apixaban
Healthy Volunteers
Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules
The purpose of this study is to evaluate the absorption of apixaban (BMS-562247) into the bloodstream of healthy volunteers, when administered as sprinkle capsules compared to tablets.
- Trial name
- NCT03509883
- Testing
- Drug: Apixaban sprinkle capsules, Experimental: Apixaban tablets followed by apixaban sprinkle capsules
- Where
- United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
N/A - Healthy Subjects
Phase 1 Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects
The purpose of this study is to assess the effect of Atenolol 100 mg on the Pharmacokinetics (PK) of Apixaban and the effect of Apixaban 10 mg on the PK of Atenolol in Healthy subjects.
- Trial name
- NCT02262533
- Testing
- Apixaban, Atenolol
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Atrial Fibrillation
The Effectiveness of Patch-Based Screening for Pre-Symptomatic Atrial Fibrillation to Improve Patient Outcome
The goal of the screening trial is to determine whether early screening for atrial fibrillation improves outcomes, including lowering the chance of death, hospitalization for stroke, blood clots, heart failure, heart attack, and…
- Trial name
- VALIANT-AF-S (NCT06953778)
- Testing
- Zio XT® Patch
- Where
- United States
- Volunteers
- 24,060 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Ischemia, Anticoagulants
Clopidogrel Aspirin Therapy (CAT) Versus Apixiban Aspirin Therapy (AAT) After Lower Limb Revascularization
the Aim of the work is to compare the effect of CAT (Clopidogrel aspirin therapy) and AAT (Apixiban aspirin therapy) after lower extremity revascularization.
- Trial name
- CVAALR (NCT04168398)
- Testing
- Combination drug
- Where
- Egypt
- Volunteers
- 1,536 people, healthy volunteers welcome
- Sponsor
- Mansoura University
End Stage Renal Disease
Pharmacokinetics and Pharmacodynamics of Apixaban in Subjects on Hemodialysis
The purpose of this study is to assess the pharmacokinetics of a single oral dose of 5 mg Apixaban in subjects with normal renal function and subjects with end stage renal disease (ESRD) maintained with hemodialysis.
- Trial name
- NCT01340586
- Testing
- Apixaban
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Bleeding
A Healthy Volunteer PK/PD, Safety and Tolerability Study of Second Generation Andexanet Alfa
This is a randomized, double-blind, study in healthy volunteers dosed to steady state with fXa inhibitors, designed to (1) demonstrate PK/PD comparability between andexanet manufactured by the Generation 1 and Generation 2…
- Trial name
- NCT03083704
- Testing
- Andexanet alfa (Gen 1 Process 2), Apixaban 5 MG, Rivaroxaban 20 MG
- Where
- United States
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Acute Ischemic Stroke
A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects
This Phase 1 study is planned to establish the clinical safety and pharmacokinetics profile of multiple dose of LT3001 drug product and to investigate drug interactions of LT3001 with potential concomitant medications in healthy…
- Trial name
- NCT04809818
- Testing
- LT3001 drug product, Aspirin, Clopidogrel
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Lumosa Therapeutics Co., Ltd.
Bleeding
A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects
"This is a single-center, randomized, double-blind, and placebo-controlled trial designed to: 1) demonstrate the degree to which administered andexanet doses can reverse Factor Ten A (FXa)-inhibitor induced anticoagulation; and…
- Trial name
- NCT03310021
- Testing
- Andexanet alfa, Apixaban, Rivaroxaban
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Bleeding
A Study in Older Subjects to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Apixaban
The purpose of this stuy is to evaluate the ability of Andexanet Alfa to reverse the anticoagulation effect of Apixaban.
- Trial name
- NCT02207725
- Testing
- Andexanet
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Atrial Fibrillation, Acute Coronary Syndrome
Triple vs. Dual Therapy
Background: The acute coronary syndrome (ACS) is a complication of coronary artery disease (CAD) and associated with increased mortality.
- Trial name
- NCT02080858
- Testing
- Ticagrelor + Apixaban + ASA, Ticagrelor + Apixaban
- Where
- Austria
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
Anticoagulant Therapy
Pharmacokinetics and Point of Care Testing of Direct Oral Anticoagulants Subjects
DOACs are increasingly used since 8 years. Standard coagulation tests (Prothrombin time [PT] and activated partial thromboplastin time [aPTT]) from plasma samples show a high variation.
- Trial name
- PHAPOCU (NCT05491460)
- Testing
- Apixaban 5 MG Tab, Dabigatran 150 MG Tab, Edoxaban 60Mg Tab
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Doasense GmbH
Direct Oral Anticoagulants (DOACs), Oral Surgical Procedures
Oral Biopsy Bleeding in Patients on Direct Oral Anticoagulants (DOACs)
Direct oral anticoagulants (DOACs) are increasingly used, but evidence on bleeding risk during oral soft tissue biopsy is limited.
- Trial name
- DOACS_BX (NCT07520890)
- Where
- Italy
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Pisa
Health
Bioequivalence Study of Apixaban 5 mg Film-Coated Tablet
This was an open-label, randomized, single-dose, two-period, two-sequence, cross-over study under fasting condition which included 24 healthy adult male and female subjects.
- Trial name
- NCT06817811
- Testing
- Apixaban 5 mg Film-Coated Tablet (produced by PT Dexa Medica), Eliquis® 5 mg film-coated tablet (Bristol-Myers Squibb Company, Puerto Rico, packed and released by Bristol-Myers Squibb S.r.l., Italy, imported by PT Pfizer Indonesia)
- Where
- Indonesia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Coagulation Disorder
Study of Intravenous VMX-C001 in Healthy Subjects and in Combination With Selected Direct Oral Anticoagulants in Healthy Older Subjects
A single centre, double-blind, randomized, parallel group, placebo-controlled study in healthy subjects conducted in two parts: Part 1: Single ascending doses in healthy subjects aged 18 to 49 years to assess safety…
- Trial name
- NCT05152420
- Testing
- VMX-C001, Apixaban, Rivaroxaban
- Where
- Netherlands
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- VarmX B.V.
Thrombosis
Bioavailability Study Comparing Modified Release To Immediate Release Apixaban Tablets In Healthy Volunteers
To estimate the pharmacokinetics of apixaban when administered as three different modified release formulation tablets relative to that when apixaban is administered as an immediate release tablet
- Trial name
- NCT00914641
- Testing
- Apixaban IR, Apixaban MR1, Apixaban MR2
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
PK and PD Interaction Between Tegoprazan and NOACs After Multiple Oral Dosing in Healthy Volunteers
This study aims to evaluate the effects of combination therapy of tegoprazan and novel oral anticoagulants (NOACs) on the pharmacokinetic and pharmacodynamic properties of NOACs in healthy adults.
- Trial name
- NCT05723510
- Testing
- Tegoprazan 50mg, Edoxaban 60mg, Apixaban 5mg
- Where
- South Korea
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Anticoagulation
A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects
The purpose of this study is to assess the effect of two 4-Factor PCC formulations on Apixaban pharmacodynamics in healthy adult subjects.
- Trial name
- NCT02074358
- Testing
- Apixaban, Cofact (4-Factor PCC), Beriplex P/N (4-Factor PCC)
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Nephrotic Syndrome, Membranous Nephropathy
A Prospective Multi-dose Study of Apixaban in Subjects With Nephrotic Syndrome
This phase I study is a single arm, multi-dose study that will evaluate steady-state apixaban pharmacokinetics (PK) and pharmacodynamics (PD) in subjects with Nephrotic Syndrome (NS) vs healthy control subjects.
- Trial name
- NCT04278729
- Testing
- Apixaban 5 MG
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Platelet Function and Reactivity Tests
Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs
This study will identify the potential benefits of regulating platelet activation with sotagliflozin compared to other FDA-approved drugs known to limit platelet activation.
- Trial name
- NCT06933056
- Testing
- Sotagliflozin (SOTA) followed by 3 drugs in a random order, Aspirin followed by 3 drugs in a random order, Clopidogrel followed by 3 drugs in a random order
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Coagulation Disorder
Single Dose Trial of VMX-C001 in Healthy Subjects With and Without FXa Direct Oral Anticoagulant
A single centre, double-blind, randomized, placebo-controlled single dose study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VMX-C001, conducted in two parts: Part 1: Single dose of…
- Trial name
- NCT06372483
- Testing
- VMX-C001, Rivaroxaban 20 mg Oral Tablet, Apixaban 5 mg Oral Tablet
- Where
- Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- VarmX B.V.