Trial · NCT05763953
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy: The percentage of patients converting to sinus rhythm (SR) in the first 15 minutes after administration of etripamil NS. | 15 minutes after administration of etripamil NS | A successful conversion is defined as conversion of PSVT to SR that is maintained for at least 30 seconds |
| Secondary | Efficacy: Time to termination of the PSVT episode and conversion to SR | 60 minutes after administration of etripamil NS | Time measured from time of dosing to time of conversion of PSVT to SR that is maintained for at least 30 seconds |
| Secondary | Efficacy: Percentage of patients requiring additional medical intervention treatment for the PSVT episode in the first 15 minutes after study drug administration. | 15 minutes after administration of etripamil NS | Medical intervention is defined as an administered drug or procedure to treat PSVT |
| Secondary | Safety: Frequency of AEs | Until 5 days after administration of etripamil NS | Adverse Events (AEs) defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related |
| Secondary | Safety: Local (administration site) tolerability | Until 5 days after administration of etripamil NS | Local tolerability defined as frequency of adverse events related to nasal spray site administration |
| Secondary | Safety: Post-dose changes in vital signs (Hearth rate (HR)) | Until 5 days after administration of etripamil NS | HR changes as measured by increase/decrease in beats per minute |
| Secondary | Safety: Post dose changes in vital sign (Blood Pressure (BP)) | Until 5 days after administration of etripamil NS | BP changes (systolic blood pressure (SBP) and diastolic blood pressure (DBP)) as measured in increase/decrease in mmHg |
| Other | Pharmacokinetic analysis of etripamil: Maximum plasma concentration (Cmax) | Within 1 hour after administration of etripamil NS | Maximum plasma concentration (Cmax) in ng/mL of etripamil assessed from PK analysis of plasma samples within 1 hour of dosing. |
| Other | Pharmacokinetic analysis of etripamil: Area under the concentration-time curve from dosing (time 0) to time t (AUC0-t). | Within 1 hour after administration of etripamil NS | Area under the concentration-time curve from dosing (time 0) to time t (AUC0-t) in min\*ng/mL of etripamil assessed from PK analysis of plasma samples within 1 hour of dosing. |
| Other | Pharmacokinetic analysis of etripamil: Area under the concentration-time curve from dosing (time 0) to time infinity (AUC0-inf). | Within 1 hour after administration of etripamil NS | Area under the concentration-time curve from dosing (time 0) to time infinity (AUC0-inf) in min\*ng/mL of etripamil assessed from PK analysis of plasma samples within 1 hour of dosing. |
| Other | Pharmacokinetic analysis of etripamil: Elimination rate constant (Kel) | Within 1 hour after administration of etripamil NS | Elimination rate constant (Kel) in 1/minutes of etripamil assessed from PK analysis of plasma samples within 1 hour of dosing. |
| Other | Pharmacokinetic analysis of etripamil: Time to achieve maximum plasma concentration (tmax) | Within 1 hour after administration of etripamil NS | Time to achieve maximum plasma concentration (tmax) in minutes of etripamil assessed from PK analysis of plasma samples within 1 hour of dosing. |
| Other | Pharmacokinetic analysis of etripamil: Half-life (t1/2) | Within 1 hour after administration of etripamil NS | Half-life (t1/2) in minutes of etripamil assessed from PK analysis of plasma samples within 1 hour of dosing. |
| Other | Pharmacokinetic analysis of MSP-2030 (inactive metabolite): Maximum plasma concentration (Cmax) | Within 1 hour after administration of etripamil NS | Maximum plasma concentration (Cmax) in ng/mL of MSP-2030 assessed from PK analysis of plasma samples within 1 hour of dosing. |
| Other | Pharmacokinetic analysis of MSP-2030 (inactive metabolite): Area under the concentration-time curve from dosing (time 0) to time t (AUC0-t). | Within 1 hour after administration of etripamil NS | Area under the concentration-time curve from dosing (time 0) to time t (AUC0-t) in min\*ng/mL of MSP-2030 assessed from PK analysis of plasma samples within 1 hour of dosing. |
| Other | Pharmacokinetic analysis of MSP-2030 (inactive metabolite): Area under the concentration-time curve from dosing (time 0) to time infinity (AUC0-inf). | Within 1 hour after administration of etripamil NS | Area under the concentration-time curve from dosing (time 0) to time infinity (AUC0-inf) in min\*ng/mL of MSP-2030 assessed from PK analysis of plasma samples within 1 hour of dosing. |
| Other | Pharmacokinetic analysis of MSP-2030 (inactive metabolite): Elimination rate constant (Kel). | Within 1 hour after administration of etripamil NS | Elimination rate constant (Kel) in 1/minutes of MSP-2030 assessed from PK analysis of plasma samples within 1 hour of dosing. |
| Other | Pharmacokinetic analysis of MSP-2030 (inactive metabolite): Time to achieve maximum plasma concentration (tmax). | Within 1 hour after administration of etripamil NS | Time to achieve maximum plasma concentration (tmax) in minutes of MSP-2030 assessed from PK analysis of plasma samples within 1 hour of dosing. |
| Other | Pharmacokinetic analysis of MSP-2030 (inactive metabolite): Half-life (t1/2) | Within 1 hour after administration of etripamil NS | Half-life (t1/2) in minutes of MSP-2030 assessed from PK analysis of plasma samples within 1 hour of dosing. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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