Trial · NCT00202644
A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients
NCT00202644, Phase 4, Completed, Shire; results first posted 2018-01-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients. Trials, record NCT00202644. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00202644
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients
- NCT number
- NCT00202644
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 150 participants, actual
- Lead sponsor
- Shire
- Conditions
- Thrombocythemia, Hemorrhagic
- Interventions
- Anagrelide, Hydroxyurea
- First posted
- 2005-09-20
- Last updated
- 2021-06-02
- Other registries' IDs
- eudract:2004-004061-15
- Results first posted
- 2018-01-24
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time | Baseline and Month 1, 2, 3, 6, 9, 12, 18, 24, 30 and 36 | The LVEF was measured by echocardiography and considered a sufficiently sensitive measure to evaluate any changes in cardiac function. |
| Primary | Platelet Count at Month 6 | Month 6 | Platelet count was evaluated. |
| Secondary | Change From Baseline in Platelet Counts at Month 3 and 36 | Baseline and Month 3 and 36 | Platelet count was evaluated throughout the study. |
| Secondary | Percentage of Participants With Complete Response | Baseline up to Month 36 | A complete response was defined as a platelet count of less than (\<) 400x10\^9/Liter which was confirmed over 2 consecutive visits at least 28 days apart. |
| Secondary | Percentage of Participants With Partial Response | Baseline up to Month 36 | A partial response is defined as a platelet count of 400-600 x 10\^9/Liter and a reduction in platelet count of at least 200 x 10\^9/Liter from baseline which was confirmed over 2 consecutive visits at least 28 days apart. |
| Secondary | Time to Complete Response | Baseline up to Month 36 | Time in days from the date of the first dose of study medication to the date of the first visit at which response was classified. If a participant did not achieve response then they were censored at their last visit in the study (Month 36 or withdrawal). |
| Secondary | Time to Partial Response | Baseline up to Month 36 | Time in days from the date of the first dose of study medication to the date of the first visit at which response was classified. If a participant did not achieve response then they were censored at their last visit in the study (Month 36 or withdrawal). |
| Secondary | Number of Participants With Thrombotic and Haemorrhagic Events | From the signing of informed consent until the last study-related visit (Month 36) | Thrombohaemorrhagic events are a well-known complication of the underlying essential thrombocythemia (ET) and disease progression. Events such as arterial and venous thrombosis, serious haemorrhage (including gastrointestinal haemorrhage), and death from vascular causes have been reported in participants who received cytoreductive treatment. |
| Secondary | Change From Baseline in White Blood Cell Count Over Time | Baseline and Month 6, 12, 18, 24, 30 and 36 | White blood cell count was evaluated throughout the study. |
| Secondary | Change From Baseline in Red Blood Cell Count Over Time | Baseline and Month 6, 12, 18, 24, 30 and 36 | Red blood cell count was evaluated throughout the study. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time | Baseline and Month 1, 2, 3, 6, 9, 12, 18, 24, 30 and 36 | The Full Analysis Set (FAS) population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded. Here, n = Number of participants analysed for specified category at the specified time points in each arm respectively. | percentage of ejection fraction | MEAN |
| PRIMARY | Platelet Count at Month 6 | Month 6 | The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded. Here, N = Number of participants analysed in each arm for this outcome measure. | 10^9 platelets per liter | MEAN |
| SECONDARY | Change From Baseline in Platelet Counts at Month 3 and 36 | Baseline and Month 3 and 36 | The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded with last observation carried forward (LOCF). Here, n=number of participants analysed for specified category at specified time points in each arm respectively. | 10^9 platelets per liter | MEAN |
| SECONDARY | Percentage of Participants With Complete Response | Baseline up to Month 36 | The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded. | percenatge of participants | NUMBER |
| SECONDARY | Percentage of Participants With Partial Response | Baseline up to Month 36 | The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded. | percentage of participants | NUMBER |
| SECONDARY | Time to Complete Response | Baseline up to Month 36 | The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded. | days | MEDIAN |
| SECONDARY | Time to Partial Response | Baseline up to Month 36 | The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded. | days | MEDIAN |
| SECONDARY | Number of Participants With Thrombotic and Haemorrhagic Events | From the signing of informed consent until the last study-related visit (Month 36) | The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded. | participants | NUMBER |
| SECONDARY | Change From Baseline in White Blood Cell Count Over Time | Baseline and Month 6, 12, 18, 24, 30 and 36 | The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded. Here, n = Number of participants analysed for specified category at the specified time points in each arm respectively. | 10^9 cells per liter | MEAN |
| SECONDARY | Change From Baseline in Red Blood Cell Count Over Time | Baseline and Month 6, 12, 18, 24, 30 and 36 | The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded. Here, n = Number of participants analysed for specified category at the specified time points in each arm respectively. | 10^12 cells per liter | MEAN |
Source ClinicalTrials.gov
Results by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time | Anagrelide | Baseline | 66.4 | Standard Deviation 4.81 | percentage of ejection fraction |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time | Hydroxyurea | Baseline | 66.9 | Standard Deviation 4.59 | percentage of ejection fraction |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time | Anagrelide | Change from baseline at Month 1 | 0.5 | Standard Deviation 4.68 | percentage of ejection fraction |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time | Hydroxyurea | Change from baseline at Month 1 | -1.1 | Standard Deviation 4.73 | percentage of ejection fraction |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time | Anagrelide | Change from baseline at Month 2 | 1.2 | Standard Deviation 5.80 | percentage of ejection fraction |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time | Hydroxyurea | Change from baseline at Month 2 | 0 | Standard Deviation 5.03 | percentage of ejection fraction |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time | Anagrelide | Change from baseline at Month 3 | 0.1 | Standard Deviation 5.31 | percentage of ejection fraction |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time | Hydroxyurea | Change from baseline at Month 3 | -0.4 | Standard Deviation 3.94 | percentage of ejection fraction |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time | Anagrelide | Change from baseline at Month 6 | -0.5 | Standard Deviation 5.68 | percentage of ejection fraction |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time | Hydroxyurea | Change from baseline at Month 6 | -0.6 | Standard Deviation 3.95 | percentage of ejection fraction |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anagrelide | 76 | |
| Overall Study | STARTED | Hydroxyurea | 70 | |
| Overall Study | COMPLETED | Anagrelide | 41 | |
| Overall Study | COMPLETED | Hydroxyurea | 43 | |
| Overall Study | NOT COMPLETED | Anagrelide | 35 | |
| Overall Study | NOT COMPLETED | Hydroxyurea | 27 |
Source ClinicalTrials.gov
Adverse events110
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 | Anagrelide | 4 | 76 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Hydroxyurea | 8 | 70 | 9 |
| other | Leukopenia | Blood and lymphatic system disorders | Anagrelide | 1 | 76 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | Hydroxyurea | 7 | 70 | 7 |
| other | Neutropenia | Blood and lymphatic system disorders | Anagrelide | 0 | 76 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Hydroxyurea | 5 | 70 | 8 |
| other | Palpitations | Cardiac disorders | Anagrelide | 18 | 76 | 29 |
| other | Palpitations | Cardiac disorders | Hydroxyurea | 0 | 70 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Anagrelide | 5 | 76 | 5 |
| other | Vertigo | Ear and labyrinth disorders | Hydroxyurea | 0 | 70 | 0 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anagrelide | ||
| Total, all-cause mortality | Hydroxyurea | ||
| Total, other adverse events | Anagrelide | 46 | 76 |
| Total, other adverse events | Hydroxyurea | 27 | 70 |
| Total, serious adverse events | Anagrelide | 17 | 76 |
| Total, serious adverse events | Hydroxyurea | 13 | 70 |
Source ClinicalTrials.gov
Papers2
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 |
|---|---|
| Anagrelide vs Hydroxyurea: Number of Participants With Thrombotic and Haemorrhagic Events | Trial comparisons |
| Anagrelide vs Hydroxyurea: 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/NCT00202644
GET https://conductscience.org/api/trials/v1/NCT00202644/results?page=2