Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction

Left Ventricle Function Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00748982
• Other study ID #: D3190C00013
• Secondary ID: 2008-001254-41
• Status: Completed
• Phase: Phase 2
• First received: September 5, 2008
• Last updated: June 22, 2011
• Start date: August 2008
• Est. completion date: July 2009

Study information

• Verified date: June 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Left Ventricle Function
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

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
iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes

Locations

Country	Name	City	State
Sweden	Research Site	Goteborg

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricular Ejection Fraction (LVEF), Change From Baseline	To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction.	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	Yes
Secondary	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.	From randomisation to last study visit (mean infusion time 1.6 hours)	Yes
Secondary	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	From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min.	Yes
Secondary	QTcF Interval	Maximum QTcF observed for each patient. QTcF is the QT interval corrected for the RR interval using the Fridericia formula	Up to 24 hours following start of IV dosing.	Yes