Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00748982
First received: September 5, 2008
Last updated: June 22, 2011
Last verified: June 2011
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Results First Received: January 25, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment |
| Condition: |
Left Ventricle Function |
| Interventions: |
Drug: AZD1305 Drug: Placebo |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| 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
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| 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. |
Reporting Groups
| Description | |
|---|---|
| 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 |
Participant Flow: Overall Study
| AZD1305 Dose 1 and Dose 2 | Placebo Dose 1 and Dose 2 | |
|---|---|---|
| STARTED | 12 | 4 |
| COMPLETED | 12 | 4 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| 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 |
| Total | Total of all reporting groups |
Baseline Measures
| AZD1305 Dose 1 and Dose 2 | Placebo Dose 1 and Dose 2 | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
12 | 4 | 16 |
|
Age
[units: Years] Mean ± Standard Deviation |
5 ± 62 | 3 ± 65 | 4 ± 254 |
|
Gender
[units: Participants] |
|||
| Female | 0 | 1 | 1 |
| Male | 12 | 3 | 15 |
Outcome Measures
| 1. Primary: | Left Ventricular Ejection Fraction (LVEF), Change From Baseline [ 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 ] |
| 2. Secondary: | Number of Subjects With at Least One Reported Adverse Event During Each Study Period and in Each Dose Group [ Time Frame: From randomisation to last study visit (mean infusion time 1.6 hours) ] |
| 3. Secondary: | Area Under Curve (AUC) ( µmol*h/L) of AZD1305 [ Time Frame: From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min. ] |
| 4. Secondary: | QTcF Interval [ Time Frame: Up to 24 hours following start of IV dosing. ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
No publications provided
| 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 |
| Study First Received: | September 5, 2008 |
| Results First Received: | January 25, 2011 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Sweden: Medical Products Agency |