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
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: Yes ]
    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) ] [ 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


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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 5, 2008
Results First Received: January 25, 2011
Last Updated: June 22, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
AZD1305
anti-arrhythmics
safety

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

ClinicalTrials.gov processed this record on July 23, 2014