ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00748982
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : June 13, 2011
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Left Ventricle Function
Interventions Drug: AZD1305
Drug: Placebo
Enrollment 16
Recruitment Details The study enrolled 33 patients and randomised 16 patients between August 2008 and July 2009 at a Clinical Pharmacology Unit located at a University Hospital in Sweden.
Pre-assignment Details Screening for eligibility and no significant changes in the medication for heart failure during the preceding 1 month before enrolment. In addition, patients for whom it was not possible to obtain high quality echocardiographic pictures were excluded from the study. The pre-entry visit was 30 days or less before the first dosing visit.
Arm/Group Title AZD1305 Dose 1 and Dose 2 Placebo Dose 1 and Dose 2
Hide Arm/Group Description AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg) Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
Period Title: Overall Study
Started 12 4
Completed 12 4
Not Completed 0 0
Arm/Group Title AZD1305 Dose 1 and Dose 2 Placebo Dose 1 and Dose 2 Total
Hide Arm/Group Description AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg) Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out Total of all reporting groups
Overall Number of Baseline Participants 12 4 16
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 4 participants 16 participants
5  (62) 3  (65) 4  (254)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 4 participants 16 participants
Female
0
   0.0%
1
  25.0%
1
   6.3%
Male
12
 100.0%
3
  75.0%
15
  93.8%
1.Primary Outcome
Title Left Ventricular Ejection Fraction (LVEF), Change From Baseline
Hide Description To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction.
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD1305 Dose 1 and Dose 2 Placebo Dose 1 and Dose 2
Hide Arm/Group Description:
AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
Overall Number of Participants Analyzed 11 4
Mean (95% Confidence Interval)
Unit of Measure: Percent change
2.00
(-0.60 to 4.60)
-3.25
(-6.53 to 0.03)
2.Secondary Outcome
Title Number of Subjects With at Least One Reported Adverse Event During Each Study Period and in Each Dose Group
Hide Description To evaluate the tolerability and safety of AZD1305 given as an iv infusion to patients with left ventricular dysfunction.
Time Frame From randomisation to last study visit (mean infusion time 1.6 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD1305 Dose 1 and Dose 2 Placebo Dose 1 and Dose 2
Hide Arm/Group Description:
AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
Overall Number of Participants Analyzed 12 4
Measure Type: Number
Unit of Measure: Participants
0 0
3.Secondary Outcome
Title Area Under Curve (AUC) ( µmol*h/L) of AZD1305
Hide Description To evaluate the pharmacokinetics of AZD1305, given as an iv infusion, in patients with left ventricular dysfunction
Time Frame From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD1305 Dose 1 and Dose 2 Placebo Dose 1 and Dose 2
Hide Arm/Group Description:
AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
Overall Number of Participants Analyzed 12 0
Mean (Full Range)
Unit of Measure: µmol*h/L
2.04
(1.41 to 2.88)
4.Secondary Outcome
Title QTcF Interval
Hide Description Maximum QTcF observed for each patient. QTcF is the QT interval corrected for the RR interval using the Fridericia formula
Time Frame Up to 24 hours following start of IV dosing.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD1305 Dose 1 and Dose 2 Placebo Dose 1 and Dose 2
Hide Arm/Group Description:
AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
Overall Number of Participants Analyzed 12 4
Mean (95% Confidence Interval)
Unit of Measure: ms
446
(409 to 512)
445
(437 to 459)
Time Frame [Not Specified]
Adverse Event Reporting Description Each patient can experience multiple AEs
 
Arm/Group Title AZD1305 Dose 1 and Dose 2 Placebo Dose 1 and Dose 2
Hide Arm/Group Description AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg) Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
All-Cause Mortality
AZD1305 Dose 1 and Dose 2 Placebo Dose 1 and Dose 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
AZD1305 Dose 1 and Dose 2 Placebo Dose 1 and Dose 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AZD1305 Dose 1 and Dose 2 Placebo Dose 1 and Dose 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/12 (8.33%)      1/4 (25.00%)    
Ear and labyrinth disorders     
Vertigo  1  1/12 (8.33%)  1 0/4 (0.00%)  0
Gastrointestinal disorders     
Abdominal Pain Upper  1  1/12 (8.33%)  1 0/4 (0.00%)  0
Diarrhoea  1  1/12 (8.33%)  1 0/4 (0.00%)  0
Flatulence  1  1/12 (8.33%)  1 0/4 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  1/12 (8.33%)  1 0/4 (0.00%)  0
Nervous system disorders     
Headache  1  1/12 (8.33%)  1 1/4 (25.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
Responsible Party: Helen Lunde, MD, Medical Science Director, Emerging Arrhythmia and Lipids, AstraZeneca
ClinicalTrials.gov Identifier: NCT00748982     History of Changes
Other Study ID Numbers: D3190C00013
2008-001254-41
First Submitted: September 5, 2008
First Posted: September 9, 2008
Results First Submitted: January 25, 2011
Results First Posted: June 13, 2011
Last Update Posted: June 27, 2011