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Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00748982
First received: September 5, 2008
Last updated: June 22, 2011
Last verified: June 2011
History of Changes

September 5, 2008
June 22, 2011
August 2008
July 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction.
Pharmacodynamic variables including QT interval and echocardiographic variables [ Time Frame: During all dosing visits ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00748982 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min. ] [ Designated as safety issue: Yes ]
    To evaluate the pharmacokinetics of AZD1305, given as an iv infusion, in patients with left ventricular dysfunction
  • QTcF Interval [ Time Frame: Up to 24 hours following start of IV dosing. ] [ Designated as safety issue: Yes ]
    Maximum QTcF observed for each patient. QTcF is the QT interval corrected for the RR interval using the Fridericia formula
  • Pharmacokinetic variables [ Time Frame: During all dosing visits ] [ Designated as safety issue: No ]
  • Adverse events, ECG, safety laboratory, vital signs, physical examination [ Time Frame: During the study ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction
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

To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Left Ventricle Function
  • Drug: AZD1305
    iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes
  • Drug: Placebo
    iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes
  • Experimental: 1
    Intervention: Drug: AZD1305
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00748982
D3190C00013, 2008-001254-41
No
Helen Lunde, MD, Medical Science Director, Emerging Arrhythmia and Lipids, AstraZeneca
AstraZeneca
Not Provided
Study Director: Helen Lund, MD AstraZeneca R&D Mölndal, Sweden
Principal Investigator: Marianne Hartford, MD AstraZeneca, Clinical Pharmacology Unit at Sahlgrenska University Hospital, Sweden
AstraZeneca
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP