Phase 2 N=16 Randomized Single-blind Treatment

Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction

Left Ventricle Function

Bottom Line

View on ClinicalTrials.gov: NCT00748982 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Jun 2011

Primary outcome: Primary: Left Ventricular Ejection Fraction (LVEF), Change From Baseline — 2.00; -3.25 Percent change

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AZD1305 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Jul 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Left Ventricular Ejection Fraction (LVEF), Change From Baseline	2.00; -3.25	—
SECONDARY Number of Subjects With at Least One Reported Adverse Event During Each Study Period and in Each Dose Group	0; 0	—
SECONDARY Area Under Curve (AUC) ( µmol*h/L) of AZD1305	2.04	—
SECONDARY QTcF Interval	446; 445	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00748982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.