Trial · NCT01552928
Effect of Anagrelide Hydrochloride on Any Changes in Heart Function in Healthy Volunteers
NCT01552928, Phase 1, Completed, Shire; results first posted 2014-01-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of Anagrelide Hydrochloride on Any Changes in Heart Function in Healthy Volunteers. Trials, record NCT01552928. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01552928
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Anagrelide Hydrochloride on Any Changes in Heart Function in Healthy Volunteers
- NCT number
- NCT01552928
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 60 participants, actual
- Lead sponsor
- Shire
- Conditions
- Healthy
- Interventions
- Anagrelide 0.5 mg, Anagrelide 2.5 mg, Moxifloxacin, Placebo
- First posted
- 2012-03-13
- Last updated
- 2021-06-09
- Other registries' IDs
- eudract:2011-005288-26
- Results first posted
- 2014-01-10
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals From Time-Matched Analysis by Largest Time Point | Over 12 hours post-dose | QT interval corrected for heart rate using the subject-specific method (QTcNi) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points. |
| Primary | Mean Difference Changes From Baseline Versus Placebo in Heart Rate From Time-Matched Analysis by Largest Time Point | Over 12 hours post-dose | The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points. |
| Primary | Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals From Time-Matched Analysis by Largest Time Point | Over 12 hours post-dose | QT interval corrected for heart rate using Fridericia's method (QTcF) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points. |
| Primary | Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals From Time-Matched Analysis by Largest Time Point | Over 12 hours post-dose | QT interval corrected for heart rate using Bazett's method (QTcB) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points. |
| Primary | Mean Difference Changes From Baseline Versus Placebo in QT Intervals From Time-Matched Analysis by Largest Time Point | Over 12 hours post-dose | The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points. |
| Secondary | Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals at Subject-Specific Time of Maximum Plasma Concentration (Tmax) | Over 12 hours post-dose | QT interval corrected for heart rate using the subject-specific method (QTcNi) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. |
| Secondary | Mean Difference Changes From Baseline Versus Placebo in Heart Rate at Subject-Specific Tmax | Over 12 hours post-dose | |
| Secondary | Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals at Subject-Specific Tmax | Over 12 hours post-dose | QT interval corrected for heart rate using Fridericia's method (QTcF) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. |
| Secondary | Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals at Subject-Specific Tmax | Over 12 hours post-dose | QT interval corrected for heart rate using Bazett's method (QTcB) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. |
| Secondary | Mean Difference Changes From Baseline Versus Placebo in QT Intervals at Subject-Specific Tmax | Over 12 hours post-dose | The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals at Subject-Specific Time of Maximum Plasma Concentration (Tmax) | Over 12 hours post-dose | Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment. | msec | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Difference Changes From Baseline Versus Placebo in Heart Rate at Subject-Specific Tmax | Over 12 hours post-dose | Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment. | beats per minute | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals at Subject-Specific Tmax | Over 12 hours post-dose | Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment. | msec | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals at Subject-Specific Tmax | Over 12 hours post-dose | Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment. | msec | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Difference Changes From Baseline Versus Placebo in QT Intervals at Subject-Specific Tmax | Over 12 hours post-dose | Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment. | msec | LEAST_SQUARES_MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) of 0.5 mg Anagrelide in Males and Females | Over 12 hours post-dose | Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin. | ng/ml | GEOMETRIC_MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) of 2.5 mg Anagrelide in Males and Females | Over 12 hours post-dose | Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin. | ng/ml | GEOMETRIC_MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) of Metabolite of 0.5 mg Anagrelide (BCH24426) in Males and Females | Over 12 hours post-dose | Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin. | ng/ml | GEOMETRIC_MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) of Metabolite of 2.5 mg Anagrelide (BCH24426) in Males and Females | Over 12 hours post-dose | Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin. | ng/ml | GEOMETRIC_MEAN |
| PRIMARY | Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals From Time-Matched Analysis by Largest Time Point | Over 12 hours post-dose | Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment. | msec | LEAST_SQUARES_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals at Subject-Specific Time of Maximum Plasma Concentration (Tmax) | Anagrelide 0.5 mg | 4.4 | 90% Confidence Interval 2.0 to 6.8 | msec | |
| Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals at Subject-Specific Time of Maximum Plasma Concentration (Tmax) | Anagrelide 2.5 mg | 8.2 | 90% Confidence Interval 4.9 to 11.6 | msec | |
| Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals at Subject-Specific Time of Maximum Plasma Concentration (Tmax) | Moxifloxacin 400 mg | 11.3 | 90% Confidence Interval 9.0 to 13.7 | msec | |
| Mean Difference Changes From Baseline Versus Placebo in Heart Rate at Subject-Specific Tmax | Anagrelide 0.5 mg | 4.5 | 90% Confidence Interval 2.7 to 6.2 | beats per minute | |
| Mean Difference Changes From Baseline Versus Placebo in Heart Rate at Subject-Specific Tmax | Anagrelide 2.5 mg | 21.8 | 90% Confidence Interval 18.3 to 25.4 | beats per minute | |
| Mean Difference Changes From Baseline Versus Placebo in Heart Rate at Subject-Specific Tmax | Moxifloxacin 400 mg | 2.9 | 90% Confidence Interval 1.5 to 4.3 | beats per minute | |
| Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals at Subject-Specific Tmax | Anagrelide 0.5 mg | 3.7 | 90% Confidence Interval 1.3 to 6.1 | msec | |
| Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals at Subject-Specific Tmax | Anagrelide 2.5 mg | 4.5 | 90% Confidence Interval 0.8 to 8.1 | msec | |
| Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals at Subject-Specific Tmax | Moxifloxacin 400 mg | 10.8 | 90% Confidence Interval 8.5 to 13.1 | msec | |
| Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals at Subject-Specific Tmax | Anagrelide 0.5 mg | 8.5 | 90% Confidence Interval 4.9 to 12.0 | msec |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg | 14 | |
| Period 1 | STARTED | Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo | 15 | |
| Period 1 | STARTED | Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg | 15 | |
| Period 1 | STARTED | Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg | 16 | |
| Period 1 | COMPLETED | Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg | 14 | |
| Period 1 | COMPLETED | Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo | 15 | |
| Period 1 | COMPLETED | Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg | 15 | |
| Period 1 | COMPLETED | Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg | 16 | |
| Period 1 | NOT COMPLETED | Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg | 0 | |
| Period 1 | NOT COMPLETED | Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events28
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 | Tachycardia | Cardiac disorders | Anagrelide 0.5mg | 0 | 59 | 0 |
| other | Tachycardia | Cardiac disorders | Anagrelide 2.5mg | 3 | 60 | 3 |
| other | Tachycardia | Cardiac disorders | Moxifloxacin 400mg | 0 | 60 | 0 |
| other | Tachycardia | Cardiac disorders | Placebo | 0 | 60 | 0 |
| other | Constipation | Gastrointestinal disorders | Anagrelide 0.5mg | 3 | 59 | 3 |
| other | Constipation | Gastrointestinal disorders | Anagrelide 2.5mg | 1 | 60 | 1 |
| other | Constipation | Gastrointestinal disorders | Moxifloxacin 400mg | 0 | 60 | 0 |
| other | Constipation | Gastrointestinal disorders | Placebo | 0 | 60 | 0 |
| other | Nausea | Gastrointestinal disorders | Anagrelide 0.5mg | 2 | 59 | 2 |
| other | Nausea | Gastrointestinal disorders | Anagrelide 2.5mg | 17 | 60 | 17 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anagrelide 0.5mg | ||
| Total, all-cause mortality | Anagrelide 2.5mg | ||
| Total, all-cause mortality | Moxifloxacin 400mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Anagrelide 0.5mg | 13 | 59 |
| Total, other adverse events | Anagrelide 2.5mg | 49 | 60 |
| Total, other adverse events | Moxifloxacin 400mg | 2 | 60 |
| Total, other adverse events | Placebo | 0 | 60 |
| Total, serious adverse events | Anagrelide 0.5mg | 0 | 59 |
| Total, serious adverse events | Anagrelide 2.5mg | 0 | 60 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01552928
GET https://conductscience.org/api/trials/v1/NCT01552928/results?page=2