Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00684307
Other study ID # D1250C00008
Secondary ID
Status Completed
Phase Phase 2
First received May 22, 2008
Last updated March 20, 2012
Start date February 2007
Est. completion date June 2008

Study information

Verified date March 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food SafetyDenmark: Danish Medicines AgencyHungary: National Institute of PharmacyIreland: Irish Medicines BoardNorway: Norwegian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian FederationSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to provide dose-guiding information by assessing the safety and tolerability of 4 different dosing regimens of an extended-release (ER) formulation of AZD0837 compared with well-controlled, dose-adjusted Vitamin-K antagonists (VKA) (aiming for an international normalized ratio (INR) 2.0 to 3.0) in patients with non-valvular atrial fibrillation (AF) with one or more additional risk factors for stroke.


Recruitment information / eligibility

Status Completed
Enrollment 1084
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Nonvalvular AF (NVAF) verified by at least two ECGs in the last year separated by at least one week.

- Previous cerebral ischemic attack (stroke or TIA, >30 days prior to randomization)

- Previous systemic embolism.

- Symptomatic congestive heart failure (CHF)

- Impaired left ventricular systolic function

- Diabetes mellitus

- Hypertension requiring anti-hypertensive treatment.

Exclusion Criteria:

- AF secondary to reversible disorders, eg hyperthyroidism, drugs and pulmonary embolism

- Known contraindication to VKA treatment

- Presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than AF requiring chronic anticoagulation treatment

- Conditions associated with increased risk of major bleeding for example: history of intracranial bleeding, history of bleeding gastrointestinal disorder or major surgical procedure or trauma two weeks prior to randomization

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
AZD0837
ER tablet, PO, once daily for a period of 3-9 months.
Vitamin-K antagonist at INR 2-3
Tablet, PO for a period of 3-9 months.
AZD0837
ER tablet, PO, twice daily for a period of 3-9 months

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Outcome

Type Measure Description Time frame Safety issue
Primary Bleeding Events Number of patients with a bleeding event while on study drug. Patients with multiple events are counted once 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit) Yes
Primary Creatinine Change in Creatinine values from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline) 12 weeks according to protocol.(baseline to week 12 visit) Yes
Primary Alanine Aminotransferase (ALAT) Number of patients while on study drug with ALAT>=3 times upper limit of normal.l 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit) Yes
Primary Bilirubin Number of patients while on study drug with Bilirubin>=2 times upper limit of normal 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit) Yes
Secondary D-Dimer Change in D-Dimer values from enrolment to week 12 visit for VKA naïve patients while on study drug (week 12 visit-enrolment) 14 weeks according to protocol.(enrolment to week 12 visit) Yes
Secondary Activated Partial Thromboplastin Time (APTT) Change in Activated partial thromboplastin time (APTT) from baseline to week 12 visit for VKA naïve patients while on study drug (week 12 visit-baseline) 12 weeks according to protocol.(baseline to week 12 visit) Yes
Secondary Ecarin Clotting Time (ECT) Change in Ecarin clotting time (ECT) from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline) 12 weeks according to protocol.(baseline to week 12 visit) Yes
Secondary Plasma Concentration of AZD0837 (Prodrug) Assessment made on the week 12 visit 12 weeks after baseline according to protocol No
Secondary Plasma Concentration of AR-H067637XX (Active Metabolite) Assessment made on the week 12 visit 12 weeks after baseline according to protocol No
Secondary Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TT Oral clearance of AR-H067637XX in subgroup of patients with genotype TT for gene polymorphism ABCB1 C3435T 36 weeks according to protocol No
Secondary Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TC Oral clearance of AR-H067637XX in subgroup of patients with genotype TC for gene polymorphism ABCB1 C3435T 36 weeks according to protocol No
Secondary Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype CC Oral clearance of AR-H067637XX in subgroup of patients with genotype CC for gene polymorphism ABCB1 C3435T 36 weeks according to protocol No
See also
  Status Clinical Trial Phase
Recruiting NCT04586972 - Safety and Efficacy of Apixaban in Very Old Geriatric Subjects (> 80 Years) With Atrial FIbrillation in a Prospective reAl World Study;
Completed NCT02007655 - Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation
Completed NCT02674594 - Evaluation of Hospital Readmissions Among Hospitalized Non-valvular Atrial Fibrillation (NVAF) Patients in the US N/A
Recruiting NCT04494347 - Watchman for Patients With Atrial Fibrillation Undergoing Transcatheter Mitral Valve Repair (WATCH-TMVR) N/A
Not yet recruiting NCT04942873 - The Adherence to Oral Anticoagulant in Chinese Patients With NVAF
Recruiting NCT05731882 - First in Man Study of Left Atrial Appendage Pulsed Field Ablation Occluder N/A
Completed NCT01885598 - Eliquis Regulatory Post Marketing Surveillance N/A
Completed NCT02919982 - Benchmarking an Oral Anticoagulant Treatment Rate in Patients With Nonvalvular Atrial Fibrillation
Recruiting NCT04073316 - AntiCoagulants and COGnition Phase 4
Completed NCT03374540 - Rivaroxaban vs Warfarin for SPAF in Multi-morbid Patients
Recruiting NCT05715658 - Pharmacokinetic Study to Evaluate Dabigatran Etexilate in Elderly Subjects N/A