Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction

This study is currently recruiting participants.

Verified by AstraZeneca, December 2008

First Received: September 5, 2008 Last Updated: December 10, 2008 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00748982

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety Study
Official Title:	A Single-Centre, Single-Blind, Randomised, Placebo-Controlled Phase IIa Study to Investigate the Effect of AZD1305 Given as an Intravenous Infusion on Left Ventricular Performance in Patients With Left Ventricular Dysfunction

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Pharmacodynamic variables including QT interval and echocardiographic variables [ Time Frame: During all dosing visits ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetic variables [ Time Frame: During all dosing visits ] [ Designated as safety issue: No ]
Adverse events, ECG, safety laboratory, vital signs, physical examination [ Time Frame: During the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	16
Study Start Date:	August 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AZD1305 iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes
2: Placebo Comparator	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

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748982

Contacts

Contact: AstraZeneca Clinical Study Information

800-236-9933

Locations

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:	AstraZeneca ( Helen Lunde, MD, Medical Science Director, Emerging Arrhythmia and Lipids )
Study ID Numbers:	D3190C00013, 2008-001254-41
Study First Received:	September 5, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00748982 History of Changes
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

AZD1305
anti-arrhythmics
safety

Study placed in the following topic categories:

Ventricular Dysfunction
Heart Diseases
Ventricular Dysfunction, Left
Anti-Arrhythmia Agents

Additional relevant MeSH terms:

Ventricular Dysfunction
Heart Diseases
Ventricular Dysfunction, Left
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009