Clinical trials: Dabigatran
Healthy
A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants
The purpose of this study is to evaluate the effect of steady-state concentrations of odalasvir (ODV), as a single agent or in combination with simeprevir (SMV), on the single-dose pharmacokinetics of dabigatran etexilate in…
- Trial name
- NCT02945020
- Testing
- Dabigatran etexilate mesylate, Odalasvir (ODV), Simeprevir (SMV)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Atrial Fibrillation or Atrial Flutter, Thrombosis of Left Atrial Appendage
Resolution of Left Atrial-Appendage Thrombus - Effects of Dabigatran in Patients With AF
The primary objective of this study is to assess whether Dabigatran leads to a faster complete left atrial appendage (LAA) thrombus resolution as compared to Phenprocoumon.
- Trial name
- RE-LATED_AF (NCT02256683)
- Testing
- Dabigatran etexilate, Phenprocoumon
- Where
- 14 sites in Germany
- Volunteers
- 64 people
- Sponsor
- Johannes Gutenberg University Mainz
Atrial Fibrillation
Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran
The purpose of this study is to evaluate the antiinflammatory effects of rivaroxaban compared with dabigatran in patients with atrial fibrillation.
- Trial name
- RIVAL-AF (NCT02331602)
- Testing
- Rivaroxaban, Dabigatran
- Where
- 16 sites in Japan
- Volunteers
- 200 people
- Sponsor
- Yokohama City University Medical Center
Renal Insufficiency, Chronic
Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Dabigatran Etexilate in Patients With Stable Severe Renal Disease.
The study to be conducted is a prospective, open label trial. It is designed to evaluate the pharmacokinetic/pharmacodynamic and coagulation parameters and safety of dabigatran etexilate in patients with chronic kidney disease.
- Trial name
- NCT01711853
- Testing
- Dabigatran Etexilate
- Where
- Netherlands
- Volunteers
- 19 people
- Sponsor
- Boehringer Ingelheim
Osteoarthritis of the Knee, Coagulopathy
Trial to See if Topical Pennsaid for Knee Pain Affects Coagulation Values in Patients Who Are Also Taking Anticoagulants
The purpose of this study is to see if using a topical nonsteroidal antiinflammatory drug (Pennsaid) to treat osteoarthritis knee pain will affect coagulation values in patients who are also taking anticoagulant or antithrombotic…
- Trial name
- ATCCTCP-1 (NCT01511939)
- Testing
- Pennsaid
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Nathan Wei, MD, FACP, FACR:
Atrial Fibrillation
Polish Atrial Fibrillation (POL-AF) Registry
Evaluation of clinical characteristics and pharmacotherapy of hospitalized Polish patients with atrial fibrillation (AF).
- Trial name
- POL-AF (NCT04419012)
- Testing
- observation
- Where
- Poland
- Volunteers
- 4,000 people
- Sponsor
- Jan Kochanowski University
Mild Cognitive Impairment, Mild Alzheimer's Disease
A Novel Therapeutic Target for Alzheimer's Disease in Men and Women 50-85 Years of Age.
A randomized-control, double-blind, multi-center, delayed-start, pilot trial evaluating the disease modifying effects of a 150mg once-a-day dose vs.
- Trial name
- NCT03752294
- Testing
- Dabigatran
- Sponsor
- University of Rhode Island
Atrial Fibrillation
Dabigatran Etexilate for Stroke Prevention in Patients With Atrial Fibrillation and Mild to Moderate Renal Impairment
Non-interventional, observational study of physicians' use of Dabigatran etexilate for stroke prevention in patients with atrial fibrillation and mild to moderate renal impairment
- Trial name
- NCT01721837
- Where
- 1,616 sites in Germany
- Volunteers
- 4,340 people
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence of Two Different Capsule Types of Dabigatran
The objective of this Phase I trial is to demonstrate the bioequivalence of two capsules of dabigatran etexilate made from two different drug product batches.
- Trial name
- NCT01290757
- Testing
- Dabigatran etexilate
- Where
- Germany
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
Cognitive Impairment Related to Atrial Fibrillation Prevention Trial
Cognitive and functional decline observed in atrial fibrillation (AF) patients are related to thrombotic and/or cardioembolic events.
- Trial name
- GIRAF (NCT01994265)
- Testing
- Warfarin, Dabigatran
- Where
- 2 sites in Brazil
- Volunteers
- 200 people
- Sponsor
- University of Sao Paulo
Renal Insufficiency
Pharmacokinetics of Midazolam, Dabigatran, Pitavastatin, Atorvastatin, and Rosuvastatin in Participants With Renal Insufficiency in the Presence and Absence of Rifampin (MK-0000-386)
The purpose of this open-label, 2-period, fixed-sequence study is to characterize the plasma pharmacokinetic profiles of midazolam, dabigatran, pitavastatin, atorvastatin, and rosuvastatin following a single oral dose…
- Trial name
- NCT03311841
- Testing
- Midazolam oral solution, Dabigatran and pitavastatin oral solution, Atorvastatin and rosuvastatin oral solution
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Coronary Artery Disease, Myocardial Ischemia
Dual Therapy With Dabigatran/Ticagrelor Versus Dual Therapy With Dabigatran/Clopidogrel in ACS Patients With Indication for NOAC Undergoing PCI
A real world registry to compare dual therapy with Dabigatran/Ticagrelor to dual therapie with Dabigatran/Clopidogrel in patients with an indication for NOAC undergoing PCI in the setting of ACS.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Myocardial Infarction, Atrial Fibrillation
- Trial name
- RE-DUAL PCI (NCT04688723)
- Testing
- Dabigatran + Ticagrelor, Dabigatran + clopidogrel
- Where
- Netherlands
- Volunteers
- 1,000 people
- Sponsor
- Zuyderland Medisch Centrum
Healthy Volunteers
Study to Assess the Effect of Co-Administration of AZD9833 on the Pharmacokinetics of Midazolam, of Omeprazole, of Celecoxib and of Dabigatran Etexilate in Healthy Postmenopausal Female Volunteers
This study will be a fixed sequence drug-drug interaction study in healthy postmenopausal females, conducted at multiple study sites
- Trial name
- NCT05438303
- Testing
- AZD9833, Midazolam, Omeprazole
- Where
- 2 sites in United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Effect of Dabigatran in Laboratory Coagulation Parameters
Effect of Dabigatran on Coagulation parameters-an ex Vivo Study
Dabigatran represent a new class of promising anticoagulation agents. As an oral direct thrombin inhibitor it has been effective in preventing venous thromboembolism in patients undergoing elective orthopaedic surgery.
- Trial name
- NCT01112202
- Where
- Germany
- Volunteers
- 70 people
- Sponsor
- Johann Wolfgang Goethe University Hospital
Deep Venous Thrombosis, Pulmonary Embolism
The DARE Warfarin CER Study
Approximately half a million Americans annually experience venous thromboembolic disease, including deep venous thrombosis (DVT) and pulmonary embolism (PE).
- Trial name
- NCT03271450
- Testing
- Dabigatran: extended treatment (e.g at least 90 days), Dabigatran: extended treatment (e.g at least 180 days), Dabigatran: extended treatment (e.g at least 270 days)
- Where
- United States
- Volunteers
- 416,000 people
- Sponsor
- Brigham and Women's Hospital
Staphylococcus Aureus Endocarditis, Staphylococcus Aureus Septicemia
Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia
This is an open-label randomized controlled trial which will enroll patients with S. aureus bacteremia who are already taking oral anticoagulant medications (apixaban, edoxaban, or rivaroxaban) for an approved indication (stroke…
- Conditions
- Staphylococcus Aureus Endocarditis, Staphylococcus Aureus Septicemia, Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Bloodstream Infection
- Trial name
- DABI-SNAP (NCT06650501)
- Testing
- Dabigatran, Apixaban, edoxaban
- Where
- 3 sites in Canada
- Volunteers
- 300 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Coronary Disease
Effects of Low Molecular Weight Heparin Versus Dabigatran on Platelet Aggregation in Patients With Stable Coronary Artery Disease
Anticoagulation with heparin is indicated in several situations, such as acute coronary disease (in combination with antiplatelet therapy) for the prevention and treatment of venous thromboembolism and situations with high risk…
- Trial name
- NCT02389582
- Testing
- Dabigatran, Enoxaparin
- Where
- Brazil
- Volunteers
- 29 people
- Sponsor
- University of Sao Paulo General Hospital
Healthy Volunteer, Dabigatran
Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting Conditions
The bioequivalence of Dabigatran Etexilate Capsules 150 mg to Boehringer Ingelheim's Pradaxa® will be assessed by a statistical comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves of…
- Conditions
- Healthy Volunteer, Dabigatran, Bioequivalence Study
- Trial name
- NCT06441916
- Testing
- Dabigatran Etexilate Capsules 150 mg
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- International Bio service
Healthy
Safety, Pharmacokinetics and Pharmacodynamics After Multiple Oral Doses of BIBR 1048 MS Capsule in Healthy Japanese Male Subjects
To investigate safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS following oral administration of multiple doses (150 mg b.i.d., 7 days)
- Trial name
- NCT02171000
- Testing
- BIBR 1048 MS
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Venous Thromboembolism
RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism
RE-COVERY is a large, multi-national, multi-center observational study based on new data collection. The study will enroll and characterize patients within 30 days of being diagnosed with an acute DVT and/or PE.
- Trial name
- NCT02596230
- Where
- 222 sites in United States, Argentina and 35 more
- Volunteers
- 7,797 people
- Sponsor
- Boehringer Ingelheim