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Cardiac Electrophysiological Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00616629
First received: February 5, 2008
Last updated: August 17, 2011
Last verified: August 2011
History of Changes
Results First Received: January 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Atrial Flutter
Intervention: Drug: AZD1305

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 68 patients were enrolled into the study. The study randomised 55 patients and 50 of those patients received study drug. All patients who received study drug completed the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
AZD1305 Dose Group 1 Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
AZD1305 Dose Group 2 Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
AZD1305 Dose Group 3 Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
AZD1305 Dose Group 4 Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
Placebo Corresponding placebo

Participant Flow:   Overall Study
    AZD1305 Dose Group 1     AZD1305 Dose Group 2     AZD1305 Dose Group 3     AZD1305 Dose Group 4     Placebo  
STARTED     13 [1]   14 [1]   14 [2]   2     12  
COMPLETED     11     12     13     2     12  
NOT COMPLETED     2     2     1     0     0  
Protocol Violation                 1                 2                 1                 0                 0  
AV-block                 1                 0                 0                 0                 0  
[1] Two patients never received study drug
[2] One patient never received study drug



  Baseline Characteristics
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Reporting Groups
  Description
AZD1305 Dose Group 1 Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
AZD1305 Dose Group 2 Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
AZD1305 Dose Group 3 Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
AZD1305 Dose Group 4 Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
Placebo Corresponding placebo
Total Total of all reporting groups

Baseline Measures
    AZD1305 Dose Group 1     AZD1305 Dose Group 2     AZD1305 Dose Group 3     AZD1305 Dose Group 4     Placebo     Total  
Number of Participants  
[units: participants]
 		  11     12     13     2     12     50  
Age  
[units: Years]
Mean ± Standard Deviation 		           
Age (years)     60  ± 14     62  ± 6     60  ± 8     50  ± 23     62  ± 6     56  ± 14.5  
Gender  
[units: Participants]
 		           
Female     2     2     2     0     0     6  
Male     9     10     11     2     12     44  



  Outcome Measures
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1.  Primary:   LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation))   [ Time Frame: 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 ]
  Show Outcome Measure 1

2.  Secondary:   RAERP (Right Atrial Effective Refractory Period)   [ Time Frame: 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 ]
  Show Outcome Measure 2

3.  Secondary:   VERP (Ventricular Effective Refractory Period)) and Other Electrophysiological and Electrocardiographic Variables; RR, P Wave Duration, PR, QRS, QTend, QTcF, QTtop, QTend - QTtop)   [ Time Frame: 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 ]
  Show Outcome Measure 3

4.  Secondary:   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)   [ Time Frame: 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. ECG measurements, including QTcF, are available from several additiona ]
  Show Outcome Measure 4

5.  Secondary:   Cmax Observed for AZD1305   [ Time Frame: During and after infusion ]
  Show Outcome Measure 5

6.  Secondary:   AUC Total of AZD1305 (Umol*h/L)   [ Time Frame: Based on PK samples during and after infusion ]
  Show Outcome Measure 6

7.  Secondary:   Number of Patients Who Had at Least One AE   [ Time Frame: During active treatment period ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca AZD1305 Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00616629     History of Changes
Other Study ID Numbers: D3190C00005, 2007-0003455-36 (EudraCT No)
Study First Received: February 5, 2008
Results First Received: January 24, 2011
Last Updated: August 17, 2011
Health Authority: Sweden: Medical Products Agency
Norway: Norwegian Medicines Agency
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency