Back to resultsInvestigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction
Primary Purpose
Left Ventricle Function
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
AZD1305
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Left Ventricle Function focused on measuring AZD1305, anti-arrhythmics, safety
Eligibility Criteria
Inclusion Criteria:
- Male patients and postmenopausal women
- Mildly/moderately decreased heart function
- Regular heart rhythm
Exclusion Criteria:
- Potassium outside normal reference values
- Child bearing potential
- Severely decreased heart function
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Left Ventricular Ejection Fraction (LVEF), Change From Baseline
To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction.
Secondary Outcome Measures
Number of Subjects With at Least One Reported Adverse Event During Each Study Period and in Each Dose Group
To evaluate the tolerability and safety of AZD1305 given as an iv infusion to patients with left ventricular dysfunction.
Area Under Curve (AUC) ( µmol*h/L) of AZD1305
To evaluate the pharmacokinetics of AZD1305, given as an iv infusion, in patients with left ventricular dysfunction
QTcF Interval
Maximum QTcF observed for each patient. QTcF is the QT interval corrected for the RR interval using the Fridericia formula
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00748982
Brief Title
Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction
Official Title
A Single-centre, Single-blind, Randomised, Placebo-controlled Phase IIa Study to Investigate the Effect of AZD1305 Given as an Intravenous (iv) Infusion on Left Ventricular Performance in Patients With Left Ventricular Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricle Function
Keywords
AZD1305, anti-arrhythmics, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AZD1305
Intervention Description
iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes
Primary Outcome Measure Information:
Title
Left Ventricular Ejection Fraction (LVEF), Change From Baseline
Description
To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction.
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
Secondary Outcome Measure Information:
Title
Number of Subjects With at Least One Reported Adverse Event During Each Study Period and in Each Dose Group
Description
To evaluate the tolerability and safety of AZD1305 given as an iv infusion to patients with left ventricular dysfunction.
Time Frame
From randomisation to last study visit (mean infusion time 1.6 hours)
Title
Area Under Curve (AUC) ( µmol*h/L) of AZD1305
Description
To evaluate the pharmacokinetics of AZD1305, given as an iv infusion, in patients with left ventricular dysfunction
Time Frame
From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min.
Title
QTcF Interval
Description
Maximum QTcF observed for each patient. QTcF is the QT interval corrected for the RR interval using the Fridericia formula
Time Frame
Up to 24 hours following start of IV dosing.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male patients and postmenopausal women
Mildly/moderately decreased heart function
Regular heart rhythm
Exclusion Criteria:
Potassium outside normal reference values
Child bearing potential
Severely decreased heart function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Lund, MD
Organizational Affiliation
AstraZeneca R&D, Mölndal, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marianne Hartford, MD
Organizational Affiliation
AstraZeneca, Clinical Pharmacology Unit at Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Goteborg
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction
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