Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction

Phase 2

Completed

• Conditions: Left Ventricle Function
• Interventions: Drug: AZD1305; Drug: Placebo

• Registration Number: NCT00748982
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-05
• Study First Submitted QC: 2008-09-05
• Study First Posted: 2008-09-09
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2011-01-25
• Results First Submitted QC: 2011-05-12
• Status Verified: 2011-06
• Results First Posted: 2011-06-13
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Male patients and postmenopausal women
• Mildly/moderately decreased heart function
• Regular heart rhythm

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Exclusion Criteria

• Potassium outside normal reference values
• Child bearing potential
• Severely decreased heart function

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD1305	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Left Ventricular Ejection Fraction (LVEF), Change From Baseline	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

Name	Time	Method
Number of Subjects With at Least One Reported Adverse Event During Each Study Period and in Each Dose Group	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	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	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

Trial Locations

Locations (1)

Research Site; 🇸🇪 Goteborg, Sweden