Atrial FibrillationPhase 4NCT01896297

Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function

A Phase 4 study testing Pradaxa, dabigatran etexilate in people with Atrial Fibrillation, run by Boehringer Ingelheim at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this study is to assess dabigatran pharmacokinetics in NVAF subjects with severe renal impairment defined as creatinine clearance between 15 and 30 mL/min calculated by Cockcroft-Gault formula. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: Pradaxa, dabigatran etexilate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 26 sitesUnited States
Study dates: Jul 2013to Oct 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects diagnosed with non-valvular atrial fibrillation with an indication for the anticoagulation therapy,
Subjects with severe renal function impairment defined as creatinine clearance between 15 and 30 mL/min by Cockcroft-Gault formula,
Male and female patients, age =18 years at entry

Who cannot join

Contraindications to Pradaxa (history of a serious hypersensitivity reaction to Pradaxa, active pathological bleeding, patients with mechanical prosthetic heart valve),
Creatinine clearance <15ml/min or patients with End Stage Renal Disease on dialysis,
Creatinine clearance >30 ml/min,
Pre-menopausal women (last menstruation less than one year prior to informed consent) who are nursing or pregnant, or are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include abstinence, tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, double barrier method and vasectomised partner,
Patients who are participating in another drug study,
Patients who have participated in another drug study within 6 weeks,
Patients considered unreliable by the investigator concerning the requirements for participating in the study, including a follow-up interview,
Any condition the investigator believes would not allow safe participation in the study,

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

1160.173.001 Boehringer Ingelheim Investigational Site
Altoona, Pennsylvania
1160.173.005 Boehringer Ingelheim Investigational Site
Columbus, Georgia
1160.173.011 Boehringer Ingelheim Investigational Site
Fort Worth, Texas
1160.173.023 Boehringer Ingelheim Investigational Site
Fremont, California
1160.173.002 Boehringer Ingelheim Investigational Site
Hot Springs, Arkansas
1160.173.020 Boehringer Ingelheim Investigational Site
Jacksonville, Florida
1160.173.036 Boehringer Ingelheim Investigational Site
Jacksonville, Florida
1160.173.037 Boehringer Ingelheim Investigational Site
Lancaster, South Carolina
1160.173.012 Boehringer Ingelheim Investigational Site
Largo, Florida
1160.173.006 Boehringer Ingelheim Investigational Site
Live Oak, Texas
1160.173.030 Boehringer Ingelheim Investigational Site
Memphis, Tennessee
1160.173.032 Boehringer Ingelheim Investigational Site
Moreno Valley, California
1160.173.027 Boehringer Ingelheim Investigational Site
Neptune City, New Jersey
1160.173.021 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
1160.173.034 Boehringer Ingelheim Investigational Site
Oceanside, California
1160.173.008 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
1160.173.025 Boehringer Ingelheim Investigational Site
Salinas, California
1160.173.033 Boehringer Ingelheim Investigational Site
San Pedro, California
1160.173.018 Boehringer Ingelheim Investigational Site
Springfield, Missouri
1160.173.019 Boehringer Ingelheim Investigational Site
St Louis, Missouri
1160.173.026 Boehringer Ingelheim Investigational Site
St Louis, Missouri
1160.173.013 Boehringer Ingelheim Investigational Site
Tampa, Florida
1160.173.010 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia
1160.173.035 Boehringer Ingelheim Investigational Site
Waukesha, Wisconsin
1160.173.024 Boehringer Ingelheim Investigational Site
Wilmington, Delaware
1160.173.014 Boehringer Ingelheim Investigational Site
Wilmington, North Carolina

Other trials in United States

About this study

Official title: A Prospective, Open Label Study to Evaluate the Pharmacokinetics of Dabigatran in Non-valvular Atrial Fibrillation (NVAF) Patients With Severely Impaired Renal Function on Dabigatran Etexilate 75 mg BID Therapy

The dabigatran etexilate dose of 75 mg BID was approved by the FDA for NVAF patients with severe renal impairment (CrCl 15-30 mL/min) , based on pharmacokinetic modeling and simulation.

Conditions: Atrial Fibrillation
Being tested: Pradaxa, dabigatran etexilate
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pradaxa, dabigatran etexilateDrug
75mg BID by oral

Study groups in NCT01896297
Study group	Role	What they receive
dabigatran etexilate	Other	75mg BID by oral Receives: Drug: Pradaxa, dabigatran etexilate

What is being measured

The primary outcome is the main question the study is designed to answer.

Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose
Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) taken at approximately 12 hours after the last dose (trough).
Measured: Immediately before the last drug administration, on day 8
Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose
Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose (C2,ss)
Measured: 2 hours after the last drug administration, on day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Oct 2015

First posted11 Jul 2013 (estimated)
Study startJul 2013
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01896297
Sponsor's protocol ID: 1160.173
Status last verified: Sep 2016
First submitted: 8 Jul 2013
Last updated: 30 Nov 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Martin JL, Esmaeili H, Manuel RC, Petrini M, Wiebe S, Maas H. Pharmacokinetics/Pharmacodynamics of Dabigatran 75 mg Twice Daily in Patients With Nonvalvular Atrial Fibrillation and Severely Impaired Renal Function. J Cardiovasc Pharmacol Ther. 2018 Sep;23(5):399-406. doi: 10.1177/1074248418769167. Epub 2018 Apr 25.
PubMed 29695165

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Open Label Study to Evaluate the Pharmacokinetics of Dabigatran in Non-valvular Atrial Fibrillation (NVAF) Patients With Severely Impaired Renal Function on Dabigatran Etexilate 75 mg BID Therapy
ClinicalTrials.gov ID: NCT01896297
Acronym / sponsor ID: 1160.173
Conditions: Atrial Fibrillation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 11 Jul 2013 (estimated)
Results: Posted 30 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The dabigatran etexilate dose of 75 mg BID was approved by the FDA for NVAF patients with severe renal impairment (CrCl 15-30 mL/min) , based on pharmacokinetic modeling and simulation.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
dabigatran etexilate	Other	Drug: Pradaxa, dabigatran etexilate75mg BID by oral

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subjects diagnosed with non-valvular atrial fibrillation with an indication for the anticoagulation therapy,
Subjects with severe renal function impairment defined as creatinine clearance between 15 and 30 mL/min by Cockcroft-Gault formula,
Male and female patients, age =18 years at entry

Key exclusion criteria (8 listed)

Contraindications to Pradaxa (history of a serious hypersensitivity reaction to Pradaxa, active pathological bleeding, patients with mechanical prosthetic heart valve),
Creatinine clearance <15ml/min or patients with End Stage Renal Disease on dialysis,
Creatinine clearance >30 ml/min,
Pre-menopausal women (last menstruation less than one year prior to informed consent) who are nursing or pregnant, or are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include abstinence, tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, double barrier method and vasectomised partner,
Patients who are participating in another drug study,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pradaxa, dabigatran etexilate75mg BID by oral	Drug	dabigatran etexilate

Primary outcome

Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose
Time frame: Immediately before the last drug administration, on day 8
Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) taken at approximately 12 hours after the last dose (trough).
Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose
Time frame: 2 hours after the last drug administration, on day 8
Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose (C2,ss)

Results and safety

Results posted to the registry on 30 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dabigatran Etexilate	60	59

Primary outcome: Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose

Time frame: Immediately before the last drug administration, on day 8. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Dabigatran Etexilate n = 51
Value	155 (76.9)

Population analysed: Pharmacokinetic (PK) set (PKS) which included all patients in the treated set with analyzable data in at least one observation for at least one primary endpoint without important protocol violations relevant to the evaluation of PK. Analysis includes patients with available data.

Primary outcome: Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose

Time frame: 2 hours after the last drug administration, on day 8. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Dabigatran Etexilate n = 59
Value	202 (70.6)

Population analysed: PKS. Analysis includes patients with available data.

Adverse events

Time frame: From first drug administration until 3 days after last drug administration, up to 18 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran Etexilate	2 of 60 (3.3%)	0 of 60 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29695165Martin JL, Esmaeili H, Manuel RC, Petrini M, Wiebe S, Maas H. Pharmacokinetics/Pharmacodynamics of Dabigatran 75 mg Twice Daily in Patients With Nonvalvular Atrial Fibrillation and Severely Impaired Renal Function. J Cardiovasc Pharmacol Ther. 2018 Sep;23(5):399-406. doi: 10.1177/1074248418769167. Epub 2018 Apr 25.
Related InfoLink provided by the sponsor.

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pradaxa, dabigatran etexilate in people with Atrial Fibrillation, run by Boehringer Ingelheim at 26 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose (time frame: Immediately before the last drug administration, on day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01896297, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2016.