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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

The purpose of the study is to measure the effects of AZD1305 on cardiac electrophysiological properties and intracardiac pressures

Cardiac electrophysiological study

Research Site

A Multi-centre, Double-blind, Randomised, Placebo-controlled, Singledose, Phase II Study to Assess the Effects on Atrial and Ventricular Refractoriness and Haemodynamics of an Intravenous Infusion of AZD1305 in Patients Undergoing an Invasive Electrophysiological Procedure

Age Continuous

Gender, Male/Female

LAERP	(Left atrial effective refractory period (ie, the longest S1-S2 interval that fails to result in atrial depolarisation))

RAERP	 (Right atrial effective refractory period)

VERP (Ventricular Effective Refractory Period)) and other electrophysiological and electrocardiographic variables; RR, P wave duration, PR, QRS, QTend, QTcF, QTtop, QTend - QTtop)

QTcF (Interval from the beginning of the Q or R wave to the end of the T wave in the surface ECG, corrected for changes in RR interval using Fridericia’ formula =QT/RR1/3 interval in seconds)

A total of 13 scheduled PK samples for each patient during and after infusion

Cmax observed for AZD1305

AUC total of AZD1305 (umol*h/L)

Number of patients who had at least one AE

Overall Study

At the pre-entry visit, which took place within 14 days before the planned catheter ablation (Study Day), patients underwent a full clinical assessment including a physical examination, ECG recording, Bood pressure(BP)/heart rate measurement, routine laboratory tests, and transthoracic echocardiography (TTE, if not done within the prior 6 months).

Cardiac electrophysiological study

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=312&filename=CSR-D3190C00005.pdf

CSR-D3190C00005.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator