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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
  Purpose
To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction

Condition Intervention Phase
Left Ventricle Function Drug: AZD1305 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 16
Study Start Date: August 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD1305
iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes
Placebo Comparator: 2 Drug: Placebo
iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00748982


Locations
Sweden
Research Site
Goteborg, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Helen Lund, MD AstraZeneca R&D Mölndal, Sweden
Principal Investigator: Marianne Hartford, MD AstraZeneca, Clinical Pharmacology Unit at Sahlgrenska University Hospital, Sweden
  More Information

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
Last Verified: June 2011

Keywords provided by AstraZeneca:
AZD1305
anti-arrhythmics
safety

Additional relevant MeSH terms:
Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases


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