Trial · NCT01648205
Long-term Efficacy Study of Sodium Channel Blocker in LQT3 Patients
NCT01648205, Phase 2, Completed, University of Rochester; results first posted 2022-04-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Efficacy Study of Sodium Channel Blocker in LQT3 Patients. Trials, record NCT01648205. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01648205
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Efficacy Study of Sodium Channel Blocker in LQT3 Patients
- NCT number
- NCT01648205
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- University of Rochester
- Conditions
- Long QT Syndrome
- Interventions
- Placebo, Ranolazine
- First posted
- 2012-07-24
- Last updated
- 2022-04-07
- Results first posted
- 2022-04-07
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 QTc Duration at 2 Months | 1 month to 2 months | Change in QTc at 2 months on ranolazine vs. at 1 month on placebo. This was prespecified outcome. |
| Secondary | Change in QTc at 6 Months | 1 month to 6 months | Change in QTc at 6 months on ranolazine vs. at 1 month on placebo. This was prespecified outcome. |
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 QTc Duration at 2 Months | 1 month to 2 months | miliseconds | MEAN | |
| SECONDARY | Change in QTc at 6 Months | 1 month to 6 months | miliseconds | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in QTc Duration at 2 Months | Placebo | 503 | Standard Deviation 46 | miliseconds | |
| Change in QTc Duration at 2 Months | Ranolazine at 2 Months | 497 | Standard Deviation 47 | miliseconds | |
| Change in QTc at 6 Months | Placebo | 504 | Standard Deviation 53 | miliseconds | |
| Change in QTc at 6 Months | Ranolazine at 6 Months | 501 | Standard Deviation 49 | miliseconds |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo | STARTED | Placebo | 25 | |
| Placebo | COMPLETED | Placebo | 21 | |
| Placebo | NOT COMPLETED | Placebo | 4 | |
| Ranolazine | STARTED | Placebo | 23 | |
| Ranolazine | COMPLETED | Placebo | 18 | |
| Ranolazine | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events4
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 | Dizziness | Nervous system disorders | Ranolazine | 3 | 25 | 3 |
| other | Dizziness | Nervous system disorders | Placebo | 0 | 25 | 0 |
| serious | Ventricular Fibrillation | Cardiac disorders | Ranolazine | 2 | 25 | 2 |
| serious | Ventricular Fibrillation | Cardiac disorders | Placebo | 0 | 25 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ranolazine | 1 | 25 |
| Total, all-cause mortality | Placebo | 0 | 25 |
| Total, other adverse events | Ranolazine | 3 | 25 |
| Total, other adverse events | Placebo | 0 | 25 |
| Total, serious adverse events | Ranolazine | 2 | 25 |
| Total, serious adverse events | Placebo | 0 | 25 |
Source ClinicalTrials.gov
Papers5
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ranolazine vs Placebo: deaths from any cause | Trial comparisons |
| Ranolazine vs Placebo: serious adverse events | Trial comparisons |
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/NCT01648205
GET https://conductscience.org/api/trials/v1/NCT01648205/registered