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Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00748982
First Posted: September 9, 2008
Last Update Posted: June 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
September 5, 2008
September 9, 2008
January 25, 2011
June 13, 2011
June 27, 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 ]
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 ]
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) ]
    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. ]
    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. ]
    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 ]
  • Adverse events, ECG, safety laboratory, vital signs, physical examination [ Time Frame: During the study ]
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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT00748982
D3190C00013
2008-001254-41
No
Not Provided
Not Provided
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