Trial Outcomes & Findings for Explorative Study of AZD1305 in Atrial Fibrillation Patients (NCT NCT00643448)
NCT ID: NCT00643448
Last Updated: 2012-01-26
Results Overview
Maximum of all QTcF values obtained for any given patient from randomisation until the intended end of the study drug period, day 10.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
During treatment days 2-10
Results posted on
2012-01-26
Participant Flow
All patients will attend a pre-entry Visit 3-28 days before the planned randomisation. At this Visit, the Investigator ensures that a signed Informed Consent Form has been obtained before any study specific procedures are conducted. Patients who have given their consent to participate in the study will then undergo a full clinical assessment
Participant milestones
| Measure |
AZD1305 Group A
AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
|
AZD1305 Group B
AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
|
Placebo
Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
22
|
22
|
|
Overall Study
COMPLETED
|
17
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
6
|
Reasons for withdrawal
| Measure |
AZD1305 Group A
AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
|
AZD1305 Group B
AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
|
Placebo
Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
4
|
|
Overall Study
Adverse Event
|
2
|
2
|
2
|
|
Overall Study
QTcF>550 ms
|
0
|
3
|
0
|
Baseline Characteristics
Explorative Study of AZD1305 in Atrial Fibrillation Patients
Baseline characteristics by cohort
| Measure |
AZD1305 Group A
n=21 Participants
AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
|
AZD1305 Group B
n=22 Participants
AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
|
Placebo
n=22 Participants
Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
Age (years)
|
65 Years
STANDARD_DEVIATION 10 • n=5 Participants
|
64 Years
STANDARD_DEVIATION 10 • n=7 Participants
|
64 Years
STANDARD_DEVIATION 9 • n=5 Participants
|
64.5 Years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: During treatment days 2-10Maximum of all QTcF values obtained for any given patient from randomisation until the intended end of the study drug period, day 10.
Outcome measures
| Measure |
AZD1305 Group A and AZD1305 Group B
n=21 Participants
AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 AZD1305 Group B loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
|
Placebo
n=22 Participants
Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
|
Placebo
Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
|
|---|---|---|---|
|
Maximum QTcF
|
461 ms
Full Range 417 • Interval 417.0 to 536.0
|
427 ms
Full Range 383 • Interval 383.0 to 465.0
|
—
|
SECONDARY outcome
Timeframe: During treatment days 2-10Number of patients who had at least one AE according to the definition in the study protocol
Outcome measures
| Measure |
AZD1305 Group A and AZD1305 Group B
n=43 Participants
AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 AZD1305 Group B loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
|
Placebo
n=21 Participants
Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
|
Placebo
Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
|
|---|---|---|---|
|
Adverse Events (AE)
|
22 Participants
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: During treatment days 1-10Population PK model parameter estimates derived from plasma concentrations of AZD1305
Outcome measures
| Measure |
AZD1305 Group A and AZD1305 Group B
n=17 Participants
AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 AZD1305 Group B loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
|
Placebo
n=17 Participants
Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
|
Placebo
Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
|
|---|---|---|---|
|
Estimated Cmax (Maximum Plasma Concentration) (PK Modeling) at Steady-state
|
0.41 μmol/L
Full Range 0.17 • Interval 0.17 to 0.83
|
0.45 μmol/L
Full Range 0.24 • Interval 0.24 to 0.84
|
—
|
SECONDARY outcome
Timeframe: During treatment days 1-10Percentage of twice daily TTM recordings (individual compliance) transmitted and available for analysis
Outcome measures
| Measure |
AZD1305 Group A and AZD1305 Group B
n=21 Participants
AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 AZD1305 Group B loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
|
Placebo
n=22 Participants
Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
|
Placebo
n=22 Participants
Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
|
|---|---|---|---|
|
Compliance With Trans Telephonic Monitoring (TTM)
|
97.4 Percentage of recordings analysed
Full Range 80 • Interval 80.0 to 100.0
|
96.4 Percentage of recordings analysed
Full Range 68.2 • Interval 68.2 to 100.0
|
98.3 Percentage of recordings analysed
Full Range 72.7 • Interval 72.7 to 100.0
|
Adverse Events
AZD1305 Group A
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
AZD1305 Group B
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD1305 Group A
AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
|
AZD1305 Group B
AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
|
Placebo
Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
|
|---|---|---|---|
|
Cardiac disorders
Ventricular Bigeminy
|
0.00%
0/21
|
4.5%
1/22
|
0.00%
0/22
|
|
Cardiac disorders
Polymorphic Ventricular Tachycardia
|
0.00%
0/21
|
4.5%
1/22
|
0.00%
0/22
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/21
|
4.5%
1/22
|
0.00%
0/22
|
Other adverse events
| Measure |
AZD1305 Group A
AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
|
AZD1305 Group B
AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
|
Placebo
Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
|
|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
4.8%
1/21
|
0.00%
0/22
|
9.1%
2/22
|
|
Cardiac disorders
Bradycardia
|
4.8%
1/21
|
9.1%
2/22
|
4.5%
1/22
|
|
Cardiac disorders
Palpitation
|
9.5%
2/21
|
4.5%
1/22
|
13.6%
3/22
|
|
General disorders
Nausea
|
9.5%
2/21
|
4.5%
1/22
|
9.1%
2/22
|
|
General disorders
Application Site Reaction
|
9.5%
2/21
|
13.6%
3/22
|
0.00%
0/22
|
|
General disorders
Oedema Peripheral
|
9.5%
2/21
|
0.00%
0/22
|
0.00%
0/22
|
|
General disorders
Qt Interval Prolonged
|
0.00%
0/21
|
13.6%
3/22
|
0.00%
0/22
|
|
Nervous system disorders
Dizziness
|
9.5%
2/21
|
18.2%
4/22
|
0.00%
0/22
|
|
Nervous system disorders
Headache
|
19.0%
4/21
|
18.2%
4/22
|
9.1%
2/22
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60