Trial · NCT02308748
Ability of Late Sodium or Calcium Current Block to Balance the ECG Effects of Potassium Current Block
NCT02308748, Phase 1, Completed, Food and Drug Administration (FDA); results first posted 2016-06-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ability of Late Sodium or Calcium Current Block to Balance the ECG Effects of Potassium Current Block. Trials, record NCT02308748. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02308748
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ability of Late Sodium or Calcium Current Block to Balance the ECG Effects of Potassium Current Block
- NCT number
- NCT02308748
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 22 participants, actual
- Lead sponsor
- Food and Drug Administration (FDA)
- Conditions
- Drug-induced QT Prolongation, Pharmacokinetics, Pharmacodynamics
- Interventions
- Dofetilide, Mexiletine, Lidocaine, Moxifloxacin, Diltiazem, Placebo
- First posted
- 2014-12-04
- Last updated
- 2016-06-08
- Results first posted
- 2016-06-08
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Placebo Corrected Change From Baseline QTc and J-Tpeakc Intervals on the ECG Measured in Milliseconds When Dofetilide is Administered With Mexiletine or Lidocaine Compared to When Dofetilide is Administered Alone at Evening Dose on Treatment Day | 5 weeks | After 3rd dose of mexiletine or lidocaine (evening dose) on treatment day when combined with dofetilide to evening dose on dofetilide alone day. |
| Secondary | Change in Placebo Corrected Change From Baseline QTc Interval on the ECG Measured in Milliseconds When Moxifloxacin is Administered With Diltiazem at the Evening Dose Compared to When Moxifloxacin is Administered Alone at Afternoon Dose on Treatment Day. | 5 weeks | Evening dose (moxifloxacin+diltiazem) versus afternoon dose (diltiazem alone). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Placebo Corrected Change From Baseline QTc and J-Tpeakc Intervals on the ECG Measured in Milliseconds When Dofetilide is Administered With Mexiletine or Lidocaine Compared to When Dofetilide is Administered Alone at Evening Dose on Treatment Day | 5 weeks | All study participants that completed placebo and dofetilide alone as well as dofetilide + mexiletine and/or dofetilide + lidocaine | ms | MEAN |
| SECONDARY | Change in Placebo Corrected Change From Baseline QTc Interval on the ECG Measured in Milliseconds When Moxifloxacin is Administered With Diltiazem at the Evening Dose Compared to When Moxifloxacin is Administered Alone at Afternoon Dose on Treatment Day. | 5 weeks | All study participants that completed placebo, moxifloxacin and moxifloxacin + diltiazem | ms | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Change in Placebo Corrected Change From Baseline QTc and J-Tpeakc Intervals on the ECG Measured in Milliseconds When Dofetilide is Administered With Mexiletine or Lidocaine Compared to When Dofetilide is Administered Alone at Evening Dose on Treatment Day | Dofetilide Alone | Placebo corrected change from baseline in QTc | 37.9 | 95% Confidence Interval 32.6 to 43.1 | ms |
Change in Placebo Corrected Change From Baseline QTc and J-Tpeakc Intervals on the ECG Measured in Milliseconds When Dofetilide is Administered With Mexiletine or Lidocaine Compared to When Dofetilide is Administered Alone at Evening Dose on Treatment Day | Dofetilide + Mexiletine | Placebo corrected change from baseline in QTc | 20.4 | 95% Confidence Interval 15.1 to 25.6 | ms |
Change in Placebo Corrected Change From Baseline QTc and J-Tpeakc Intervals on the ECG Measured in Milliseconds When Dofetilide is Administered With Mexiletine or Lidocaine Compared to When Dofetilide is Administered Alone at Evening Dose on Treatment Day | Dofetilide + Lidocaine | Placebo corrected change from baseline in QTc | 18 | 95% Confidence Interval 12.7 to 23.3 | ms |
Change in Placebo Corrected Change From Baseline QTc and J-Tpeakc Intervals on the ECG Measured in Milliseconds When Dofetilide is Administered With Mexiletine or Lidocaine Compared to When Dofetilide is Administered Alone at Evening Dose on Treatment Day | Dofetilide Alone | Placebo corrected change from baseline in J-Tpeakc | 24.0 | 95% Confidence Interval 19.2 to 28.9 | ms |
Change in Placebo Corrected Change From Baseline QTc and J-Tpeakc Intervals on the ECG Measured in Milliseconds When Dofetilide is Administered With Mexiletine or Lidocaine Compared to When Dofetilide is Administered Alone at Evening Dose on Treatment Day | Dofetilide + Mexiletine | Placebo corrected change from baseline in J-Tpeakc | 0.8 | 95% Confidence Interval -4.0 to 5.6 | ms |
Change in Placebo Corrected Change From Baseline QTc and J-Tpeakc Intervals on the ECG Measured in Milliseconds When Dofetilide is Administered With Mexiletine or Lidocaine Compared to When Dofetilide is Administered Alone at Evening Dose on Treatment Day | Dofetilide + Lidocaine | Placebo corrected change from baseline in J-Tpeakc | 3.5 | 95% Confidence Interval -1.4 to 8.4 | ms |
Change in Placebo Corrected Change From Baseline QTc Interval on the ECG Measured in Milliseconds When Moxifloxacin is Administered With Diltiazem at the Evening Dose Compared to When Moxifloxacin is Administered Alone at Afternoon Dose on Treatment Day. | Moxifloxacin Alone | 29.9 | 95% Confidence Interval 24.6 to 35.2 | ms | |
Change in Placebo Corrected Change From Baseline QTc Interval on the ECG Measured in Milliseconds When Moxifloxacin is Administered With Diltiazem at the Evening Dose Compared to When Moxifloxacin is Administered Alone at Afternoon Dose on Treatment Day. | Moxifloxacin + Diltiazem | 31.3 | 95% Confidence Interval 26.0 to 36.6 | ms |
Source ClinicalTrials.gov
Participant flow150
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | A-D-E-C-B | 2 | |
| Period 1 | STARTED | B-C-E-D-A | 2 | |
| Period 1 | STARTED | C-D-B-A-E | 2 | |
| Period 1 | STARTED | D-C-A-B-E | 2 | |
| Period 1 | STARTED | E-A-B-D-C | 2 | |
| Period 1 | STARTED | D-A-C-E-B | 3 | |
| Period 1 | STARTED | E-B-A-C-D | 2 | |
| Period 1 | STARTED | A-E-D-B-C | 2 | |
| Period 1 | STARTED | B-E-C-A-D | 2 | |
| Period 1 | STARTED | C-B-D-E-A | 3 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 participant flowAdverse events15
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizzines | Nervous system disorders | Dofetilide | 1 | 20 | 1 |
| other | Dizzines | Nervous system disorders | Dofetilide + Lidocaine | 1 | 19 | 1 |
| other | Dizzines | Nervous system disorders | Dofetilide + Mexiletine | 6 | 21 | 6 |
| other | Dizzines | Nervous system disorders | Moxifloxacin + Diltiazem | 2 | 20 | 2 |
| other | Dizzines | Nervous system disorders | Placebo | 1 | 20 | 1 |
| other | Nausea | Gastrointestinal disorders | Dofetilide | 1 | 20 | 1 |
| other | Nausea | Gastrointestinal disorders | Dofetilide + Lidocaine | 0 | 19 | |
| other | Nausea | Gastrointestinal disorders | Dofetilide + Mexiletine | 4 | 21 | 4 |
| other | Nausea | Gastrointestinal disorders | Moxifloxacin + Diltiazem | 3 | 20 | 3 |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 20 | 2 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dofetilide | ||
| Total, all-cause mortality | Dofetilide + Lidocaine | ||
| Total, all-cause mortality | Dofetilide + Mexiletine | ||
| Total, all-cause mortality | Moxifloxacin + Diltiazem | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Dofetilide | 3 | 20 |
| Total, other adverse events | Dofetilide + Lidocaine | 1 | 19 |
| Total, other adverse events | Dofetilide + Mexiletine | 11 | 21 |
| Total, other adverse events | Moxifloxacin + Diltiazem | 6 | 20 |
| Total, other adverse events | Placebo | 3 | 20 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT02308748
GET https://conductscience.org/api/trials/v1/NCT02308748/flow?page=2