Page last updated: 2024-10-16
carbamates and Torsade de Pointes
carbamates has been researched along with Torsade de Pointes in 2 studies
Research Excerpts
| Excerpt | Relevance | Reference |
|---|
| "Two patients experienced torsade de pointes (TdP): one patient without symptoms in dose group 3, and one patient requiring DC defibrillation in dose group 4." | 2.76 | Pharmacological cardioversion of atrial fibrillation--a double-blind, randomized, placebo-controlled, multicentre, dose-escalation study of AZD1305 given intravenously. ( Alings, M; Berggren, A; Bondarov, P; Edvardsson, N; Egstrup, K; Figatowski, W; Frison, L; Gaciong, Z; Hranai, M; Johansson, S; Király, C; Rónaszéki, A; Sereg, M, 2011) |
| "Toxicological effects of repeat dosing were assessed in naïve monkeys." | 1.38 | Investigation of mechanism of drug-induced cardiac injury and torsades de pointes in cynomolgus monkeys. ( Albassam, M; Frantz, C; Gralinski, MR; Guo, L; Kolaja, KL; Ly, J; Misner, DL; Senese, PB, 2012) |
Research
Studies (2)
| Timeframe | Studies, this research(%) | All Research% |
|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 2 (100.00) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
Authors
| Authors | Studies |
|---|
| Rónaszéki, A | 1 |
| Alings, M | 1 |
| Egstrup, K | 1 |
| Gaciong, Z | 1 |
| Hranai, M | 1 |
| Király, C | 1 |
| Sereg, M | 1 |
| Figatowski, W | 1 |
| Bondarov, P | 1 |
| Johansson, S | 1 |
| Frison, L | 1 |
| Edvardsson, N | 1 |
| Berggren, A | 1 |
| Misner, DL | 1 |
| Frantz, C | 1 |
| Guo, L | 1 |
| Gralinski, MR | 1 |
| Senese, PB | 1 |
| Ly, J | 1 |
| Albassam, M | 1 |
| Kolaja, KL | 1 |
Clinical Trials (1)
Trial Overview
| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| A Double-blind, Randomised, Placebo-controlled, Multicentre, Dose-escalating Study of AZD1305 Given Intravenously for Cardioversion of Atrial Fibrillation[NCT00915356] | Phase 2 | 228 participants (Actual) | Interventional | 2009-05-31 | Completed |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial Outcomes
Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 10 Hours to 7 Days
(NCT00915356)
Timeframe: Conversion from AF to SR within 90 minutes from start of infusion
| Intervention | Participants (Number) |
|---|
| AZD1305 Dose Group 1 | 0 |
| AZD1305 Dose Group 2 | 2 |
| AZD1305 Dose Group 3 | 5 |
| AZD1305 Dose Group 4 | 1 |
| Placebo | 0 |
Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 31 Days - 3 Months
Subgroup analysis for patients with duration of current AF episode 31 days - 3 months. Number of patients converting from AF to SR. (NCT00915356)
Timeframe: Conversion from AF to SR within 90 minutes from start of infusion
| Intervention | Participants (Number) |
|---|
| AZD1305 Dose Group 1 | 2 |
| AZD1305 Dose Group 2 | 2 |
| AZD1305 Dose Group 3 | 6 |
| AZD1305 Dose Group 4 | 3 |
| Placebo | 0 |
Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 8 Days - 30 Days.
Subgroup analysis for patients with duration of current AF episode 8 days - 30 days. Number of patients converting from AF to SR. (NCT00915356)
Timeframe: Conversion from AF to SR within 90 minutes from start of infusion
| Intervention | Participants (Number) |
|---|
| AZD1305 Dose Group 1 | 0 |
| AZD1305 Dose Group 2 | 4 |
| AZD1305 Dose Group 3 | 6 |
| AZD1305 Dose Group 4 | 2 |
| Placebo | 0 |
Conversion of Atrial Fibrillation (AF) and Maintenance of Sinus Rhytm (SR)
Conversion of AF to SR with maintenance of SR maintained for at least 1 minute (NCT00915356)
Timeframe: Within 90 minutes from start of infusion
| Intervention | Percentage of patients converted to SR (Number) |
|---|
| AZD1305 Dose Group 1 | 7.7 |
| AZD1305 Dose Group 2 | 17.8 |
| AZD1305 Dose Group 3 | 37.8 |
| AZD1305 Dose Group 4 | 50.0 |
| Placebo | 0.0 |
Dose-response Relationship for QTcF Interval of AZD1305
QTcF-QT interval corrected for the RR interval (the time elapsing between two consecutive R waves in the electrocardiogram (ECG)) using the Fridericia formula.For each of 3 consecutive beats (5 consecutive beats if AF) a manual measurement, preferably in lead V2, of QTend intervals was done.The mean QT values of the 3 consecutive beats (5 consecutive beats if AF) were, together with RR intervals, date & time of the ECG, entered into the eCase Report Form (eCRF).The selected beats had to be marked with calipers and noted together with measured values and calculations on the print-out and signed (NCT00915356)
Timeframe: At any time post randomisation until end of Holter recording (18-24 hours post start of drug infusion).
| Intervention | ms (Mean) |
|---|
| AZD1305 Dose Group 1 | 461 |
| AZD1305 Dose Group 2 | 486 |
| AZD1305 Dose Group 3 | 490 |
| AZD1305 Dose Group 4 | 482 |
| Placebo | 440 |
Heart Rhythm. Number of Participants With Early Relapse Into AF.
Early relapse into AF within 5 minutes from obtaining the defined criterion for conversion to SR (i.e.1 minute in SR). Patients never converted are not included in the analysis. (NCT00915356)
Timeframe: Within 5 minutes following investigational product (IP) induced conversion, or direct current (DC) cardioversion, of AF to SR
| Intervention | Participants (Number) |
|---|
| AZD1305 Dose Group 1 | 1 |
| AZD1305 Dose Group 2 | 1 |
| AZD1305 Dose Group 3 | 2 |
| AZD1305 Dose Group 4 | 0 |
| Placebo | 1 |
Heart Rhythm. Number of Patients Remaining in SR up to 13 to 18 Days Following Study Drug Infusion.
Number of patients in SR at day 13-18 (NCT00915356)
Timeframe: During 13 to 18 days following study drug infusion
| Intervention | Participants (Number) |
|---|
| AZD1305 Dose Group 1 | 14 |
| AZD1305 Dose Group 2 | 23 |
| AZD1305 Dose Group 3 | 25 |
| AZD1305 Dose Group 4 | 7 |
| Placebo | 22 |
Heart Rhythm. Number of Patients Remaining in SR up to 24 h Following Start of Study Drug Infusion
(NCT00915356)
Timeframe: During 24 hours following start of study drug infusion
| Intervention | Participants (Number) |
|---|
| AZD1305 Dose Group 1 | 23 |
| AZD1305 Dose Group 2 | 34 |
| AZD1305 Dose Group 3 | 36 |
| AZD1305 Dose Group 4 | 10 |
| Placebo | 33 |
Maximal Observed Plasma Concentration of AZD1305
Plasma concentration of AZD1305 (NCT00915356)
Timeframe: Up to 24 hours following start of study drug infusion
| Intervention | mol/L (Median) |
|---|
| AZD1305 Dose Group 1 | 0.521 |
| AZD1305 Dose Group 2 | 1.28 |
| AZD1305 Dose Group 3 | 1.39 |
| AZD1305 Dose Group 4 | 1.69 |
Percentage of Patients, Discharged Within 6 h (QTcF ≤500 ms) After Start of Infusion
Percentage, with 95% confidence interval, of patients with QTcF≤500 ms six hours following start of study drug infusion (NCT00915356)
Timeframe: Six hours following start of study drug infusion
| Intervention | Percent of participants (Number) |
|---|
| AZD1305 Dose Group 1 | 100.0 |
| AZD1305 Dose Group 2 | 95.5 |
| AZD1305 Dose Group 3 | 91.1 |
| AZD1305 Dose Group 4 | 100.0 |
| Placebo | 100.0 |
Wide QRS Tachycardias
Number of patients with wide QRS tachycardias, determined as significant arrhythmias by an Adjudication Committee (AC). The AC analysed and classified the occurrence of significant arrhythmias (other than AF or AFl) and pauses based on the 12-lead Holter reports. All pauses (≥3 sec) and all wide QRS complex tachycardias (≥3 beats, QRS ≥120 ms, and ≥120 bpm). (NCT00915356)
Timeframe: From start of study drug infusion until discharge from hospital on study day 2.
| Intervention | Participants (Number) |
|---|
| AZD1305 Dose Group 1 | 4 |
| AZD1305 Dose Group 2 | 15 |
| AZD1305 Dose Group 3 | 16 |
| AZD1305 Dose Group 4 | 2 |
| Placebo | 7 |
Trials
1 trial available for carbamates and Torsade de Pointes
| Article | Year |
|---|
Pharmacological cardioversion of atrial fibrillation--a double-blind, randomized, placebo-controlled, multicentre, dose-escalation study of AZD1305 given intravenously.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2011, Volume: 13, Issue:8
Topics: Adult; Aged; Anti-Arrhythmia Agents; Atrial Fibrillation; Azabicyclo Compounds; Carbamates; Dose-Res | 2011 |
Other Studies
1 other study available for carbamates and Torsade de Pointes