Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction

NCT ID: NCT00748982

Last Updated: 2011-06-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-07-31

Brief Summary

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

Detailed Description

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Conditions

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Left Ventricle Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

AZD1305

Intervention Type DRUG

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

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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AZD1305

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Helen Lund, MD

Role: STUDY_DIRECTOR

AstraZeneca R&D, Mölndal, Sweden

Marianne Hartford, MD

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca, Clinical Pharmacology Unit at Sahlgrenska University Hospital, Sweden

Locations

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Research Site

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2008-001254-41

Identifier Type: -

Identifier Source: secondary_id

D3190C00013

Identifier Type: -

Identifier Source: org_study_id

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