Trial · NCT01585298
STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START)
NCT01585298, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2019-09-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START). Trials, record NCT01585298. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01585298
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START)
- NCT number
- NCT01585298
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 6,998 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Multiple Sclerosis
- Interventions
- FTY720
- First posted
- 2012-04-25
- Last updated
- 2019-09-23
- Results first posted
- 2019-09-23
- Limitations and caveats
- 292 centers were initiated but 278 centers randomized patients.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants With 2nd or 3rd Degree Atrioventricular (AV) Block | baseline, during 6 hour monitoring post first dose observation | AV Blocks/Heart block is an abnormal heart rhythm where the heart beats too slowly; the electrical signals that tell the heart to contract are partially intermittent (Type 2:1) or slowed (1st and 2nd degree) or blocked (3rd degree) between the upper chambers (atria) and the lower chambers (ventricles). In 2nd degree AV Blocks, electrical impulses are intermittent (type 2:1) or delayed w/ each subsequent heartbeat (Mobitz type I) until a beat fails to reach the ventricles entirely. This type of block often is physiologic and observed in a highly relaxed state \& during sleep. In 2nd degree AV Blocks type II, the atria electrical impulses are unable to reach the ventricles, a more serious condition. In 3rd degree AV Blocks (complete heart block), none of the electrical impulses reach either the atria or the ventricles. Patients can experience simultaneously both types of 2nd or 3rd degree AV Blocks without any symptoms. |
| Primary | Number of Patients With Heart Rate Below 45 Beats Per Minute (BPM) | baseline during 6 hour monitoring post dose | Number of patients with heart rate below 45 beats bpm in ECG during first dose observation |
| Secondary | Number of Participants With Prolonged QTc Interval (Friderica) | baseline post-dose | Number of patients with conduction abnormalities such as QT prolongation, first degree AV block during treatment initiation. The QT interval is a period between the activation and the regeneration of ventricular contraction. A prolonged QT interval can be a potential marker of cardiac arrhythmias. Two patients of the safety analysis set discontinued the study without having received treatment, but safety information was collected on these two patients. |
| Secondary | Number of Participants With Bradyarrhythmic Electrocardiogram (ECG) Events | up to day 7 | The number of participants with bradyarrhythmic electrocardiogram (ECG) events was assessed. Bradyarrhythmic ECG events are defined as QTc Fridericia time \> 450 ms for males and \> 470 ms for females. |
| Secondary | Number of Patients With Cardiac Adverse Events | 7 days | The number of participants with the occurrence of subsequent cardiac adverse events (AEs) and serious cardiac AEs during study was assessed. Cardiac events were defined as the following Medical Dictionary for Regulatory Activities (MedDRA) preferred terms: angina pectoris, chest discomfort, dizziness, dyspnoea, dyspnoea exertional, fatigue, palpitations, syncope, vertigo, vertigo positional and vision blurred. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants With 2nd or 3rd Degree Atrioventricular (AV) Block | baseline, during 6 hour monitoring post first dose observation | Safety set: The safety set consisted of all enrolled participants for whom safety information was collected. Two patients of the safety analysis set discontinued the study without having received treatment, but safety information was collected on these two patients. | Participants | NUMBER |
| PRIMARY | Number of Patients With Heart Rate Below 45 Beats Per Minute (BPM) | baseline during 6 hour monitoring post dose | Safety set: The safety set consisted of all enrolled participants for whom safety information was collected. Two patients of the safety analysis set discontinued the study without having received treatment, but safety information was collected on these two patients. | Participants | NUMBER |
| SECONDARY | Number of Participants With Prolonged QTc Interval (Friderica) | baseline post-dose | The safety set, which consisted of all enrolled participants for whom safety information was collected, was considered for the analysis. Only participants, who had baseline post-dose QTc interval data, were analyzed.~Of the 6998 patients, 6844 patients had complete baseline post-dose QTc interval data. | Participants | NUMBER |
| SECONDARY | Number of Participants With Bradyarrhythmic Electrocardiogram (ECG) Events | up to day 7 | Safety set: The safety set consisted of all enrolled participants for whom safety information was collected. Two patients of the safety analysis set discontinued the study without having received treatment, but safety information was collected on these two patients. | Participants | NUMBER |
| SECONDARY | Number of Patients With Cardiac Adverse Events | 7 days | Safety set: The safety set consisted of all enrolled participants for whom safety information was collected. Two patients of the safety analysis set discontinued the study without having received treatment, but safety information was collected on these two patients. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants With 2nd or 3rd Degree Atrioventricular (AV) Block | Fingolimod | Any AV block ll degree or higher | 120 | Participants | |
| Participants With 2nd or 3rd Degree Atrioventricular (AV) Block | Fingolimod | AV block ll degree: Mobitz type I degree | 117 | Participants | |
| Participants With 2nd or 3rd Degree Atrioventricular (AV) Block | Fingolimod | AV block II degree: Mobitz type II degree | 0 | Participants | |
| Participants With 2nd or 3rd Degree Atrioventricular (AV) Block | Fingolimod | AV block II degree: 2:1 | 43 | Participants | |
| Participants With 2nd or 3rd Degree Atrioventricular (AV) Block | Fingolimod | AV block III degree | 1 | Participants | |
| Number of Patients With Heart Rate Below 45 Beats Per Minute (BPM) | Fingolimod | 63 | Participants | ||
| Number of Participants With Prolonged QTc Interval (Friderica) | Fingolimod | Female, QTcFridericia Interval > 470 ms | 7 | Participants | |
| Number of Participants With Prolonged QTc Interval (Friderica) | Fingolimod | Male, QTcF Interval > 450 ms | 6 | Participants | |
| Number of Participants With Bradyarrhythmic Electrocardiogram (ECG) Events | Fingolimod | 26 | Participants | ||
| Number of Patients With Cardiac Adverse Events | Fingolimod | Cardiac events | 489 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fingolimod | 6,998 | |
| Overall Study | COMPLETED | Fingolimod | 6,961 | |
| Overall Study | NOT COMPLETED | Fingolimod | 37 |
Source ClinicalTrials.gov
Adverse events514
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 | Anaemia | Blood and lymphatic system disorders | Fingolimod | 4 | 6,998 | |
| other | Eosinopenia | Blood and lymphatic system disorders | Fingolimod | 7 | 6,998 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Fingolimod | 12 | 6,998 | |
| other | Granulocytosis | Blood and lymphatic system disorders | Fingolimod | 1 | 6,998 | |
| other | Haemoglobinaemia | Blood and lymphatic system disorders | Fingolimod | 1 | 6,998 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Fingolimod | 11 | 6,998 | |
| other | Leukopenia | Blood and lymphatic system disorders | Fingolimod | 68 | 6,998 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Fingolimod | 5 | 6,998 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Fingolimod | 119 | 6,998 | |
| other | Microcytic anaemia | Blood and lymphatic system disorders | Fingolimod | 1 | 6,998 |
1 to 10 of 514Source ClinicalTrials.gov
See all 514 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fingolimod | ||
| Total, other adverse events | Fingolimod | 2,179 | 6,998 |
| Total, serious adverse events | Fingolimod | 160 | 6,998 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28100182 | 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/NCT01585298
GET https://conductscience.org/api/trials/v1/NCT01585298/events?page=2