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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001254-41 |
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To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1305 | Drug | iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With at Least One Reported Adverse Event During Each Study Period and in Each Dose Group | To evaluate the tolerability and safety of AZD1305 given as an iv infusion to patients with left ventricular dysfunction. | From randomisation to last study visit (mean infusion time 1.6 hours) |
| Area Under Curve (AUC) ( µmol*h/L) of AZD1305 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen Lund, MD | AstraZeneca R&D, Mölndal, Sweden | Study Director |
| Marianne Hartford, MD | AstraZeneca, Clinical Pharmacology Unit at Sahlgrenska University Hospital, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gothenburg | 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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Left Ventricular Ejection Fraction (LVEF), Change From Baseline | To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction. | Posted | Jan 2011 | Mean | 95% Confidence Interval | Percent change | 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 |
|
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Each patient can experience multiple AEs
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| C550721 | tert-butyl (2-(7-(2-(4-cyano-2-fluorophenoxy)ethyl)-9-oxa-3,7-diazabicyclo(3.3.1)non3-yl)ethyl)carbamate |
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| Placebo | Drug | iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes |
|
To evaluate the pharmacokinetics of AZD1305, given as an iv infusion, 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. |
| QTcF Interval | Maximum QTcF observed for each patient. QTcF is the QT interval corrected for the RR interval using the Fridericia formula | Up to 24 hours following start of IV dosing. |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | 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 |
|
|
| Secondary | Number of Subjects With at Least One Reported Adverse Event During Each Study Period and in Each Dose Group | To evaluate the tolerability and safety of AZD1305 given as an iv infusion to patients with left ventricular dysfunction. | Posted | Jan 2011 | Number | Participants | From randomisation to last study visit (mean infusion time 1.6 hours) |
|
|
|
| Secondary | Area Under Curve (AUC) ( µmol*h/L) of AZD1305 | To evaluate the pharmacokinetics of AZD1305, given as an iv infusion, in patients with left ventricular dysfunction | Posted | Jan 2011 | Mean | Full Range | µmol*h/L | From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min. |
|
|
|
| Secondary | QTcF Interval | Maximum QTcF observed for each patient. QTcF is the QT interval corrected for the RR interval using the Fridericia formula | Posted | Jan 2011 | Mean | 95% Confidence Interval | ms | Up to 24 hours following start of IV dosing. |
|
|
|
| 0 |
| 0 |
| 1 |
| 12 |
| EG001 | 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 | 0 | 0 | 1 | 4 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
The PI was employed at AstraZeneca and had therefore to follow AZ policy.