NCT00748982

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 5, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
2 years until next milestone

Results Posted

Study results publicly available

June 13, 2011

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

11 months

First QC Date

September 5, 2008

Results QC Date

January 25, 2011

Last Update Submit

June 22, 2011

Conditions

Left Ventricle Function

Keywords

AZD1305anti-arrhythmicssafety

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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)

  • 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.

  • QTcF Interval

    Up to 24 hours following start of IV dosing.

Study Arms (2)

1

EXPERIMENTAL
Drug: AZD1305

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD1305DRUG

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

1
PlaceboDRUG

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

2

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Gothenburg, Sweden

Location

MeSH Terms

Interventions

tert-butyl (2-(7-(2-(4-cyano-2-fluorophenoxy)ethyl)-9-oxa-3,7-diazabicyclo(3.3.1)non3-yl)ethyl)carbamate

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Helen Lund, MD

    AstraZeneca R&D, Mölndal, Sweden

    STUDY DIRECTOR

  • Marianne Hartford, MD

    AstraZeneca, Clinical Pharmacology Unit at Sahlgrenska University Hospital, Sweden

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 5, 2008

First Posted

September 9, 2008

Study Start

August 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

June 27, 2011

Results First Posted

June 13, 2011

Record last verified: 2011-06

Locations

SE(1)