Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study

December 17, 2008 updated by: Advanz Pharma
To evaluate the safety, tolerability and efficacy of 3 doses of vernakalant (oral) (150 mg, 300 mg and 500 mg b.i.d.) administered for up to 90 days in subjects with sustained symptomatic atrial fibrillation (AF duration > 72 hours and < 6 months).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
735

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
        • Royal Adelaide Hospital
      • Hobart, Australia
        • Royal Hobart Hospital
      • Launceston, Australia
        • Launceston General Hospital
      • Woodville, Australia
        • Queen Elizabeth Hospital
      • Woolloongabba, Australia
        • Princess Alexandra Hospital
  • Belgium
      • Antwerp, Belgium
        • A. Z. Middelheim
      • Bonheiden, Belgium
        • Imelda Ziekenhuis
      • Leuven, Belgium
        • U. Z. Gasthuisberg
      • Roeselare, Belgium
        • Heilig Hart Ziekenhuis
  • Bulgaria
      • Haskovo, Bulgaria
        • MHAT - Haskovo
      • Pleven, Bulgaria
        • UMHAT 'Dr. Georgi Stranski'
      • Rousse, Bulgaria
        • MHAT 'Rouse AD'
      • Sofia, Bulgaria
        • Military Medical Academy
      • Sofia, Bulgaria
        • IV MHAT
      • Sofia, Bulgaria
        • MHAT 'Tzaritza Yoanna'
      • Sofia, Bulgaria
        • MI Central Clinical Base - Ministry of Interior
      • Varna, Bulgaria
        • MHAT 'Sveta Marina'
      • Varna, Bulgaria
        • MMA - Hospital Base for Active Treatment - Varna
  • Croatia
      • Zadar, Croatia
        • General Hospital Zadar
      • Zagreb, Croatia
        • Clinical Hospital Dubrava
      • Zagreb, Croatia
        • General Hospital Sveti Duh
      • Zagreb, Croatia
        • University Hospital " Merkur "
  • Czech Republic
      • Jindrichuv Hradec, Czech Republic
        • Nemocnice Jindrichuv Hradec, a.s.
      • Kromeriz, Czech Republic
        • Kromerizska Nemocnice, a.s.
      • Kutna Hora, Czech Republic
        • Nemocnice Kutna Hora s.r.o.
      • Plzen, Czech Republic
        • Fakultni Nemocnice Plzen
      • Praha, Czech Republic
        • Vojenska Nemocnice Praha
      • Praha, Czech Republic
        • Vseobecna fakultni nemocnice v Praze
      • Pribram, Czech Republic
        • Oblastní nemocnice Příbram, a.s.
      • Semily, Czech Republic
        • Nemocnice v Semilech
      • Slany, Czech Republic
        • Nemocnice Slany
      • Tabor, Czech Republic
        • Nemocnice Tabor, a.s.
      • Trebic, Czech Republic
        • Nemocnice Trebic, p.o.
  • Denmark
      • Copenhagen, Denmark
        • Bispebjerg Hospital
      • Frederiksberg, Denmark
        • Frederiksberg Hospital
      • Hellerup, Denmark
        • Gentofte Amtssygehus
      • Hjorring, Denmark
        • Sygehus Vendsyssel - Hjørring
      • Koge, Denmark
        • Region Sjælland Sygehus øst Køge
      • Kolding, Denmark
        • Kolding Sygehus
  • Estonia
      • Haabneeme, Estonia
        • Viimsi Hospital
      • Parnu, Estonia
        • Parnu Hospital
      • Tallinn, Estonia
        • North Estonia Regional Hospital
      • Tartu, Estonia
        • Tartu University Hospital
  • Germany
      • Bad Krozingen, Germany
        • Herzzentrum Bad Krozingen
      • Bad Nauheim, Germany
        • Kerckhoff-Klinik Forschungsgesellschaft mbH
      • Witten, Germany
        • Evangelisches Krankenhaus
  • Hungary
      • Ajka, Hungary
        • Magyar Imre Hospital
      • Baja, Hungary
        • Baja City Community Hospital
      • Budapest, Hungary
        • Nyiro Gyula Hospital
      • Budapest, Hungary
        • Péterfy Sándor Hospital
      • Budapest, Hungary
        • Szent Istvan Hospital
      • Gyongyos, Hungary
        • Bugat Pal Hospital
      • Gyor, Hungary
        • Petz Aladár County Teaching Hospital
      • Kecskemet, Hungary
        • Bacs-Kiskun County Hospital
      • Szekesfehervar, Hungary
        • Fejer Megyei Szent Gyorgy Korhaz
      • Szolnok, Hungary
        • Hetenyi Geza County Hospital
      • Zalaegerszeg, Hungary
        • Zala County Hospital
  • Lithuania
      • Kaunas, Lithuania
        • Kaunas Medical University Hospital
      • Klaipeda, Lithuania
        • Klaipeda Seamen's Hospital
      • Vilnius, Lithuania
        • Vilnius University Hospital Santariskiu Clinic
  • Netherlands
      • Amsterdam, Netherlands
        • VU Medisch Centrum
      • Delft, Netherlands
        • Reinier de Graaf Groep
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
      • Groningen, Netherlands
        • Martini Ziekenhuis
      • Maastricht, Netherlands
        • Academisch Ziekenhuis Maastricht
      • Nieuwegein, Netherlands
        • Stichting Sint Antonius Ziekenhuis
      • Zwolle, Netherlands
        • Isala Klinieken
  • New Zealand
      • Auckland, New Zealand
        • North Shore Hospital
      • Dunedin, New Zealand
        • Dunedin Hospital
      • Hamilton, New Zealand
        • Waikato Hospital
      • Nelson, New Zealand
        • Nelson Hospital
  • Poland
      • Bydgoszcz, Poland
        • SZZOZ Wielospecjalityczny Szpital Miejski im. Dr. E.Warminsk
      • Chrzanow, Poland
        • Szpital Powiatowy
      • Gdansk, Poland
        • Instytut Kardiologii AMG
      • Gdynia, Poland
        • Szpital Miejski w Gdyni
      • Lodz, Poland
        • Zaklad Farmakologii i Terapii Monitorowanej z Oddzialem Chor
      • Lublin, Poland
        • SP ZOZ Okregowy Szpital Kolejowy
      • Rzeszow, Poland
        • Szpital Wojewodzki Nr 2
      • Szczecin, Poland
        • Klinika Kardiologii PAM
      • Tarnow, Poland
        • Szpital Specjalistyczny
      • Warsaw, Poland
        • III Klinika Chorob Wewnetrznych i Kardiologii
      • Warsaw, Poland
        • Wojskowy Instytut Medyczny, CSK MON
      • Wroclaw, Poland
        • Osrodek Chorob Serca, 4Wojskowy Szpital Kliniczny z Poliklin
  • Portugal
      • Amadora, Portugal
        • Hospital Fernando da Fonseca
      • Lisbon, Portugal
        • Hospital de Santa Marta
      • Vila Nova de Gaia, Portugal
        • Centro Hospitalar Vila Nova de Gaia
  • Romania
      • Arad, Romania
        • Spitalul Clinic Judetean de Urgenta Arad
      • Brasov, Romania
        • Spitalul Clinic Judetean de Urgenta Brasov
      • Bucuresti, Romania
        • Institutul de Cardiologie C.C. Iliescu
      • Bucuresti, Romania
        • Spitalul Clinic Colentina
      • Bucuresti, Romania
        • Spitalul Clinic de Urgenta Sf. Pantelimon
      • Lasi, Romania
        • Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi
      • Oradea, Romania
        • Spitalul Clinic Judetean Oradea
      • Ploiesti, Romania
        • Spitalul Judetean de Urgenta Ploiesti
      • Targu Mures, Romania
        • Spitalul Clinic Judetean de Urgenta Targu Mures
      • Timisoara, Romania
        • Spitalul Clinic Municipal de Urgenta Timisoara
  • Russian Federation
      • Moscow, Russian Federation
        • FSI EMC of the President of RF, b.o. City Hospital #51
      • Moscow, Russian Federation
        • MedCentre of RF President, Central Clinical Hospital
      • Moscow, Russian Federation
        • Moscow City Hospital # 29
      • Moscow, Russian Federation
        • Moscow Medical Academy. City Hospital #20
      • Moscow, Russian Federation
        • Moscow SHI City Clinical Hospital #52
      • Moscow, Russian Federation
        • RMA of Postg. education b.o. Botkin City Clinical Hospital
      • Moscow, Russian Federation
        • Russian Cardiology Research Centre
      • Moscow, Russian Federation
        • War Veteran's Hospital #3
      • St Petersburg, Russian Federation
        • Pokrovskaya City Hospital
      • St Petersburg, Russian Federation
        • St- Petersburg GUZ City Hospital #15
      • Yaroslavl, Russian Federation
        • Yaroslavl Regional Clinical Hospital
      • Yaroslavl, Russian Federation
        • Yaroslavl State Medical Academy b.o. Clinical Hospital #2
  • Serbia
      • Belgrade, Serbia
        • Clinical Center of Serbia
      • Belgrade, Serbia
        • Dedinje Cardiovascular Institute
      • Belgrade, Serbia
        • Institute of CV Diseases, Clinical Center of Serbia
      • Niska Banja, Serbia
        • Clinical Center for Cardiovascular Diseases
      • Sremska Kamenica, Serbia
        • Institute of Cardiovascular Diseases Sremska Kamenica
      • Zemun, Serbia
        • Clinical Center Bezanijska kosa
      • Zemun, Serbia
        • Clinical Center Zemun
  • Singapore
      • Singapore, Singapore
        • National Heart Center
  • Slovakia
      • Bratislava, Slovakia
        • FNsP Bratislava - Pracovisko Stare Mesto
      • Bratislava, Slovakia
        • Slovensky Ustav Srdcovocievnych Chorob
      • Kosice, Slovakia
        • Vychodoslovensky Ustav Srdcovocievnych Chorob
      • Nitra, Slovakia
        • Fakultna nemocnica Nitra
      • Nove Zamky, Slovakia
        • FNsP Nove Zamky
      • Presov, Slovakia
        • FNsP J. A. Reimana
  • South Africa
      • Kempton Park, South Africa
        • Clinresco Centres (Pty) Ltd
      • Somerset West, South Africa
        • Vergelegen Medi-Clinic
      • Worcester, South Africa
        • Clinical Project Research
  • Spain
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Granada, Spain
        • Hosp. Virgen de las Nieves
      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Clinica Universitaria Puerta de Hierro
      • Madrid, Spain
        • Hosp. Clinico San Carlos
      • Tarragona, Spain
        • Hospital Univ. Tarragona Joan XXIII
  • Sweden
      • Malmo, Sweden
        • Universitetssjukhuset Malmö
      • Orebro, Sweden
        • Universitetssjukhuset Orebro
      • Uppsala, Sweden
        • Akademiska Sjukhuset
  • Switzerland
      • Basel, Switzerland
        • Universitaetsspital Basel
      • Liestal, Switzerland
        • Kantonsspital Liestal
      • Lugano, Switzerland
        • Cardio Centro Ticino
      • St Gallen, Switzerland
        • Kantonsspital St. Gallen
  • Ukraine
      • Dnepropetrovsk, Ukraine
        • Reg.Diag.Center of Dnepr.
      • Donetsk, Ukraine
        • Cent.City Clin.Hosp.#3.Chair of Int.Dis.#2 of Donetsk SMU
      • Donetsk, Ukraine
        • Donetsk Regional Clinical Hospital
      • Kharkov, Ukraine
        • City Clinical Hospital #8
      • Kiev, Ukraine
        • City Clinical Hospital #1
      • Kiev, Ukraine
        • Kiev City Clinical Hospital No 5, Coronary Care Unit
      • Kiev, Ukraine
        • Kiev Clinical Emergency Care Hospital
      • Kiev, Ukraine
        • M.D.Strazhesko Institut of Cardiology
      • Kiev, Ukraine
        • N.D. Strazhesko Institute of Cardiology
      • Lugansk, Ukraine
        • Lugansk First Clinical Multiprofile Hospital #1, Cardiology
      • Lviv, Ukraine
        • Lviv Reg St Clinical Treat-and-Diagn Cardio. Centre
      • Odessa, Ukraine
        • City Clinical Hospital #9
      • Zaporizhzhya, Ukraine
        • Hospital Therapy Dept #1of Zaporozhye SMU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Comprehend and sign a written informed consent form, (per local and national regulations, as applicable)
  • Be 18 to 85 years of age
  • Women must not be pregnant, be non-nursing and if pre-menopausal, must be using an effective form of birth control from time of screening until 3 months after the last dose of medication. Methods of birth control considered to be effective may include hormonal contraception (the pill), an intrauterine device (IUD), condoms in combination with a spermicidal cream, total abstinence or sterilisation. Men should be advised not to conceive a child and are advised to use an effective form of birth control from admission until 3 months after the last dose of study medication
  • Have symptomatic AF that has been sustained for greater than 72 hours and less than 6 months duration and is clinically indicated for cardioversion;
  • Have adequate anticoagulant therapy for cardioversion in accordance with standard of practice as recommended by ACC/AHA/ESC guidelines (Fuster V. et al, 2006);
  • Be haemodynamically stable (100 mmHg < systolic blood pressure < 190 mmHg) at screening and on Day 1 before dosing (while taking rate control drugs, if required). After resting supine for 3 minutes, blood pressures should be measured 3 times in 5 minutes with at least 1 minute between assessments;
  • Have a body weight between 45 and 113 kg (99 and 250 lbs).

Exclusion Criteria:

  • Have known prolonged QT syndrome or QTcB interval of >0.500 sec as measured at screening on a 12 lead ECG; familial long QT syndrome; previous Torsades de Pointes; ventricular fibrillation; or sustained ventricular tachycardia (VT).
  • Have a QRS >0.140 sec;
  • Documented previous episodes of second or third-degree atrioventricular block;
  • Have clinically significant persistent bradycardia with ventricular rate below 50 beats/min, sick-sinus syndrome or pacemaker;
  • Have clinically significant moderate or severe aortic valvular stenosis (gradient >25 mmHg), hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis;
  • Have Class III or Class IV congestive heart failure at screening or admission, or have been hospitalized for heart failure in the previous 6 months;
  • Have a myocardial infarction (MI), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study; h) Have serious pulmonary, hepatic, metabolic, renal (serum creatinine > 2.0 mg/dl), gastrointestinal, central nervous system (CNS) or psychiatric disease, end-stage disease states, or any other disease that could interfere with the conduct or validity of the study or compromise subject safety;
  • Have known concurrent temporary secondary causes of AF such as alcohol intoxication, pulmonary embolism, hyperthyroidism, pneumonia, hypoxemia (oxygen saturation < 90% on room air), acute pericarditis, or myocarditis;
  • Potassium (K+) <3.5 mmol/L or >5.5 mmol/L or magnesium (Mg2+) below the lower limit of normal (Mg2+< 0.65 mmol/L in subjects 65 years or younger and <0.80 mmol/L in subjects 66 years or older). (Both K+ and Mg2+ should be corrected prior to dosing);
  • Have clinical evidence of digoxin toxicity;
  • Have received an oral Class I or Class III antiarrhythmic agent (including sotalol) within 3 days of randomisation or oral amiodarone within 4 weeks, or have received intravenous Class I or Class III antiarrhythmic agent or i.v. amiodarone within 24 hours prior to start of dosing;
  • Have any other surgical or medical condition that, in the judgment of the clinical Investigator might warrant exclusion or be contraindicated for safety reasons;
  • Be concurrently participating in another drug study or have received an investigational drug within 30 days prior to screening;
  • Be unable to communicate well with the Investigator and to comply with the requirements of the entire study;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: 1
Placebo (b.i.d.)
Drug: Placebo
Experimental: 2
Vernakalant (oral), 150 mg (b.i.d.)
Drug: Vernakalant (oral)
Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
Other Names:
  • RSD1235-SR
Experimental: 3
Vernakalant (oral), 300 mg (b.i.d.)
Drug: Vernakalant (oral)
Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
Other Names:
  • RSD1235-SR
Experimental: 4
Vernakalant (oral), 500 mg (b.i.d.)
Drug: Vernakalant (oral)
Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
Other Names:
  • RSD1235-SR

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Time to first documented recurrence of symptomatic sustained AF.
Time Frame: Time to first documented recurrence of symptomatic sustained AF within Day 90 of dosing
Time to first documented recurrence of symptomatic sustained AF within Day 90 of dosing
Safety assessments- Vital signs, safety laboratory assays, ECG parameters, physical examinations, and frequency of adverse events
Time Frame: Safety assessments within Day 120 of dosing
Safety assessments within Day 120 of dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to first documented recurrence of symptomatic or asymptomatic sustained AF
Time Frame: Time to first documented recurrence of symptomatic or asymptomatic sustained AF within 90 days of dosing
Time to first documented recurrence of symptomatic or asymptomatic sustained AF within 90 days of dosing
Time to first documented recurrence of symptomatic AF
Time Frame: Time to first documented recurrence of symptomatic AF within 90 days of dosing
Time to first documented recurrence of symptomatic AF within 90 days of dosing
Time to first documented recurrence of symptomatic or asymptomatic AF
Time Frame: Time to first documented recurrence of symptomatic or asymptomatic AF within 90 days of dosing
Time to first documented recurrence of symptomatic or asymptomatic AF within 90 days of dosing
Proportion of subjects in sinus rhythm on Day 90.
Time Frame: Proportion of subjects in sinus rhythm on Day 90 of dosing
Proportion of subjects in sinus rhythm on Day 90 of dosing
Improvement in AF symptoms as assessed by an AF symptom checklist.
Time Frame: Improvement in AF symptoms as assessed by an AF symptom checklist within Day 90 of dosing
Improvement in AF symptoms as assessed by an AF symptom checklist within Day 90 of dosing
Improvement in QOL as measured by SF-36
Time Frame: Improvement in QOL as measured by SF-36 within Day 90 of dosing
Improvement in QOL as measured by SF-36 within Day 90 of dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Advanz Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gregory Beatch, PhD, Advanz Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1235-SR-202-AF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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