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AZD1305

Phase 2

Atrial Fibrillation | Small molecule | Cardiovascular |AstraZeneca PLC|Trials Updated: Feb 1, 2012

AZD1305 development status

Highest phase Phase 2
Registered trials 13 across 1 sponsor since Feb 2008

AZD1305 target and mechanism

Molecular targetKCNH2, SCN5A, CACNA1C, CACNA1S, CACNA1D, CACNA1F
Target classBlocker
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials5
Total Enrollment382

FDA Designations

No designations recorded

AZD1305 clinical trials

AZD1305 · 5 trials · 3 indications

Phase 2 4Phase 1 1
NCT00915356Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305Atrial Fibrillation
COMPLETED228 Analytics
NCT00748982Investigate the Effect of AZD1305 on Patients With Left Ventricular DysfunctionLeft Ventricle Function
COMPLETED16 Analytics
NCT00643448Explorative Study of AZD1305 in Atrial Fibrillation PatientsAtrial Fibrillation
COMPLETED65 Analytics
NCT00616629Cardiac Electrophysiological StudyAtrial Flutter
COMPLETED55 Analytics
PHASE2COMPLETED
Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305
Atrial FibrillationUnlock trial analytics
PHASE2COMPLETED
Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction
Left Ventricle FunctionUnlock trial analytics
PHASE2COMPLETED
Explorative Study of AZD1305 in Atrial Fibrillation Patients
Atrial FibrillationUnlock trial analytics
PHASE2COMPLETED
Cardiac Electrophysiological Study
Atrial FlutterUnlock trial analytics

Study Endpoints

Primary Endpoints

Dose-response Relationship for QTcF Interval of AZD1305
At any time post randomisation until end of Holter recording (18-24 hours post start of drug infusion).

QTcF-QT interval corrected for the RR interval (the time elapsing between two consecutive R waves in the electrocardiogram (ECG)) using the Fridericia formula.For each of 3 consecutive beats (5 consecutive beats if AF) a manual measurement, preferably in lead V2, of QTend intervals was done.The mean QT values of the 3 consecutive beats (5 consecutive beats if AF) were, together with RR intervals, date \& time of the ECG, entered into the eCase Report Form (eCRF).The selected beats had to be marked with calipers and noted together with measured values and calculations on the print-out and signed

Conversion of Atrial Fibrillation (AF) and Maintenance of Sinus Rhytm (SR)
Within 90 minutes from start of infusion

Conversion of AF to SR with maintenance of SR maintained for at least 1 minute

Left Ventricular Ejection Fraction (LVEF), Change From Baseline
From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out

To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction.

Maximum QTcF
During treatment days 2-10

Maximum of all QTcF values obtained for any given patient from randomisation until the intended end of the study drug period, day 10.

LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation))
Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product

Absolute change, after - before infusion

Pharmacokinetic variables
During all dosing visits

Secondary Endpoints

Wide QRS Tachycardias
From start of study drug infusion until discharge from hospital on study day 2.
Heart Rhythm. Number of Participants With Early Relapse Into AF.
Within 5 minutes following investigational product (IP) induced conversion, or direct current (DC) cardioversion, of AF to SR
Heart Rhythm. Number of Patients Remaining in SR up to 24 h Following Start of Study Drug Infusion
During 24 hours following start of study drug infusion
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALAZD1305 iv infusion
2PLACEBO_COMPARATORPlacebo iv infusion
AZD1305 loading dose 250 mg + 125 mgEXPERIMENTALTablets
AZD1305 loading dose 500 mg + placeboEXPERIMENTALTablets
Placebo corresponding to AZD1305 loading dosePLACEBO_COMPARATORTablets
3ACTIVE_COMPARATORDigoxin

Interventions

NameTypeDescription
AZD1305DRUGIntravenous (iv) single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes
PlaceboDRUGiv single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes
DigoxinDRUGTablet, repeated administration
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Eligibility Criteria

Age Range20 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * Clinical indication for cardioversion of Atrial Fibrillation, ie a correction of irregular heart rhythm to normal heart rhythm * Current episode of Atrial Fibrillation (ie irregular heart rhythm) lasting up to 3 months at randomisation * Adequate anticoagulation according to i...

Countries:CzechiaDenmarkHungaryNetherlandsNorwayPolandSlovakiaSwedenRussiaFinland
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Competitive Landscape -Atrial Fibrillation 159 trials

Frequently asked questions about AZD1305

What is AZD1305 used for?

AZD1305 was studied for the treatment of atrial fibrillation and atrial flutter, and was also evaluated in patients with left ventricular dysfunction. It is an investigational small molecule that was developed as an intravenous cardioversion agent for restoring normal sinus rhythm in patients with these cardiac arrhythmias.

What does AZD1305 target?

AZD1305 targets multiple cardiac ion channels: KCNH2, SCN5A, CACNA1C, CACNA1S, CACNA1D, and CACNA1F. It acts as a blocker at these targets, which include potassium, sodium, and calcium channels involved in cardiac electrical activity. This multi-channel blocking profile was intended to stabilize cardiac rhythm.

Who is developing AZD1305?

AZD1305 was developed by AstraZeneca PLC, which trades on the NASDAQ under the ticker AZN. AstraZeneca sponsored the clinical trials of AZD1305, including studies in atrial fibrillation and left ventricular dysfunction.

What phase is AZD1305 in?

AZD1305 reached Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. All three completed trials were Phase 2 studies, and no active trials are currently listed.

What clinical trials is AZD1305 in?

AZD1305 has been studied in three completed clinical trials. These include NCT00915356, a Phase 2 trial of intravenous cardioversion in atrial fibrillation; NCT00748982, a Phase 2 trial in patients with left ventricular dysfunction; and NCT00643448, a Phase 2 explorative study in atrial fibrillation patients.

Is AZD1305 the same as other names?

AZD1305 is the only name used for this investigational compound in the clinical trial records. No alternative names or synonyms are referenced in the available data.