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Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction

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ClinicalTrials.gov Identifier: NCT00748982
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : June 13, 2011
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
AstraZeneca

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Left Ventricle Function
Interventions: Drug: AZD1305
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study enrolled 33 patients and randomised 16 patients between August 2008 and July 2009 at a Clinical Pharmacology Unit located at a University Hospital in Sweden.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening for eligibility and no significant changes in the medication for heart failure during the preceding 1 month before enrolment. In addition, patients for whom it was not possible to obtain high quality echocardiographic pictures were excluded from the study. The pre-entry visit was 30 days or less before the first dosing visit.

Reporting Groups
  Description
AZD1305 Dose 1 and Dose 2 AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
Placebo Dose 1 and Dose 2 Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out

Participant Flow:   Overall Study
    AZD1305 Dose 1 and Dose 2   Placebo Dose 1 and Dose 2
STARTED   12   4 
COMPLETED   12   4 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
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.
No text entered.

Reporting Groups
  Description
AZD1305 Dose 1 and Dose 2 AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
Placebo Dose 1 and Dose 2 Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
Total Total of all reporting groups

Baseline Measures
   AZD1305 Dose 1 and Dose 2   Placebo Dose 1 and Dose 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   4   16 
Age 
[Units: Years]
Mean (Standard Deviation)
 5  (62)   3  (65)   4  (254) 
Gender 
[Units: Participants]
     
Female   0   1   1 
Male   12   3   15 


  Outcome Measures

1.  Primary:   Left Ventricular Ejection Fraction (LVEF), Change From Baseline   [ Time Frame: 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 ]

2.  Secondary:   Number of Subjects With at Least One Reported Adverse Event During Each Study Period and in Each Dose Group   [ Time Frame: From randomisation to last study visit (mean infusion time 1.6 hours) ]

3.  Secondary:   Area Under Curve (AUC) ( µmol*h/L) of AZD1305   [ Time Frame: From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min. ]

4.  Secondary:   QTcF Interval   [ Time Frame: Up to 24 hours following start of IV dosing. ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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



Responsible Party: Helen Lunde, MD, Medical Science Director, Emerging Arrhythmia and Lipids, AstraZeneca
ClinicalTrials.gov Identifier: NCT00748982     History of Changes
Other Study ID Numbers: D3190C00013
2008-001254-41
First Submitted: September 5, 2008
First Posted: September 9, 2008
Results First Submitted: January 25, 2011
Results First Posted: June 13, 2011
Last Update Posted: June 27, 2011