Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction

June 22, 2011 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Goteborg, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From randomisation to last study visit (mean infusion time 1.6 hours)
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
From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min.
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
Up to 24 hours following start of IV dosing.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

September 5, 2008

First Submitted That Met QC Criteria

September 5, 2008

First Posted (Estimate)

September 9, 2008

Study Record Updates

Last Update Posted (Estimate)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3190C00013
  • 2008-001254-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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