Trial Outcomes & Findings for Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction (NCT NCT00748982)
NCT ID: NCT00748982
Last Updated: 2011-06-27
Results Overview
To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
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
Results posted on
2011-06-27
Participant Flow
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.
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.
Participant milestones
| Measure |
AZD1305 Dose 1 and Dose 2
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)
|
Placebo Dose 1 and Dose 2
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 Study
STARTED
|
12
|
4
|
|
Overall Study
COMPLETED
|
12
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction
Baseline characteristics by cohort
| Measure |
AZD1305 Dose 1 and Dose 2
n=12 Participants
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)
|
Placebo Dose 1 and Dose 2
n=4 Participants
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
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
5 Years
STANDARD_DEVIATION 62 • n=5 Participants
|
3 Years
STANDARD_DEVIATION 65 • n=7 Participants
|
4 Years
STANDARD_DEVIATION 254 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 outTo explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction.
Outcome measures
| Measure |
AZD1305 Dose 1 and Dose 2
n=11 Participants
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)
|
Placebo Dose 1 and Dose 2
n=4 Participants
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
|
|---|---|---|
|
Left Ventricular Ejection Fraction (LVEF), Change From Baseline
|
2.00 Percent change
95% Confidence Interval -0.60 • Interval -0.6 to 4.6
|
-3.25 Percent change
95% Confidence Interval -6.53 • Interval -6.53 to 0.03
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
AZD1305 Dose 1 and Dose 2
n=12 Participants
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)
|
Placebo Dose 1 and Dose 2
n=4 Participants
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
|
|---|---|---|
|
Number of Subjects With at Least One Reported Adverse Event During Each Study Period and in Each Dose Group
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
AZD1305 Dose 1 and Dose 2
n=12 Participants
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)
|
Placebo Dose 1 and Dose 2
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
|
|---|---|---|
|
Area Under Curve (AUC) ( µmol*h/L) of AZD1305
|
2.04 µmol*h/L
Interval 1.41 to 2.88
|
—
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
AZD1305 Dose 1 and Dose 2
n=12 Participants
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)
|
Placebo Dose 1 and Dose 2
n=4 Participants
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
|
|---|---|---|
|
QTcF Interval
|
446 ms
95% Confidence Interval 409 • Interval 409.0 to 512.0
|
445 ms
95% Confidence Interval 437 • Interval 437.0 to 459.0
|
Adverse Events
AZD1305 Dose 1 and Dose 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Dose 1 and Dose 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AZD1305 Dose 1 and Dose 2
n=12 participants at risk
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)
|
Placebo Dose 1 and Dose 2
n=4 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
8.3%
1/12 • Number of events 1
Each patient can experience multiple AEs
|
0.00%
0/4
Each patient can experience multiple AEs
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Number of events 1
Each patient can experience multiple AEs
|
0.00%
0/4
Each patient can experience multiple AEs
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
1/12 • Number of events 1
Each patient can experience multiple AEs
|
0.00%
0/4
Each patient can experience multiple AEs
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1
Each patient can experience multiple AEs
|
25.0%
1/4 • Number of events 1
Each patient can experience multiple AEs
|
|
Ear and labyrinth disorders
Vertigo
|
8.3%
1/12 • Number of events 1
Each patient can experience multiple AEs
|
0.00%
0/4
Each patient can experience multiple AEs
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
1/12 • Number of events 1
Each patient can experience multiple AEs
|
0.00%
0/4
Each patient can experience multiple AEs
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI was employed at AstraZeneca and had therefore to follow AZ policy.
- Publication restrictions are in place
Restriction type: OTHER