Trial · NCT00989001
A Phase 3b Study of Vernakalant Injection in Patients With Recent Onset Symptomatic Atrial Fibrillation (AF)(MK-6621-045)
NCT00989001, Phase 3, Terminated, Advanz Pharma
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 3b Study of Vernakalant Injection in Patients With Recent Onset Symptomatic Atrial Fibrillation (AF)(MK-6621-045). Trials, record NCT00989001. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00989001
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3b Study of Vernakalant Injection in Patients With Recent Onset Symptomatic Atrial Fibrillation (AF)(MK-6621-045)
- NCT number
- NCT00989001
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 217 participants, actual
- Lead sponsor
- Advanz Pharma
- Conditions
- Atrial Fibrillation
- Interventions
- Vernakalant, Placebo
- First posted
- 2009-10-02
- Last updated
- 2014-03-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants who Experience Hypotension, Ventricular Arrhythmias and/or Death | Occurring within the first two hours after start of study treatment | Hypotension defined as: systolic blood pressure (SBP) \<90 mmHg and treated with pressors; SBP \<90 mmHg and treated with albumin, dextran or hydroxyethyl starch; or SBP \<90 mmHg and seizures. Ventricular arrhythmias defined as: Sustained ventricular tachycardia with a heart rate of \>120 beats per minute. Sustained tachycardia defined as lasting \>30 seconds; Torsade de Pointes with a duration of \>10 seconds; Ventricular fibrillation of any duration. |
| Primary | Number of Participant with Successful Conversion to Sinus rhythm (SR) | Occurring within 90 minutes of first exposure to study treatment | Successful conversion defined as return to sinus rhythm for at least 1 minute documented by Holter electrocardiogram (ECG) or by two consecutive 12-lead ECGs recorded \> 1 minute apart within 90 minutes of first exposure to study treatment |
| Secondary | Time from First Exposure to Study Treatment to Conversion of AF to SR | Occurring within 90 minutes after study treatment | |
| Secondary | Number of Participants who Report No Symptoms | Occurring 90 minutes after first exposure to study treatment | Participant was considered a success (no symptoms) if they did not have any of the following symptoms at 90 minutes: palpitations, dyspnea, dizziness, chest pain or fatigue |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27233239 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00989001
GET https://conductscience.org/api/trials/v1/NCT00989001/registered