Trial · NCT01214915
Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia
NCT01214915, Phase 3, Completed, Shire; results first posted 2013-09-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia. Trials, record NCT01214915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01214915
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia
- NCT number
- NCT01214915
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 53 participants, actual
- Lead sponsor
- Shire
- Conditions
- Essential Thrombocythemia (ET)
- Interventions
- Anagrelide Hydrochloride
- First posted
- 2010-10-05
- Last updated
- 2021-06-09
- Results first posted
- 2013-09-25
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects Who Responded in Platelet Count | 12 months | A response was defined as platelet counts to \<600x10\^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment. |
| Secondary | Percentage of Subjects With at Least 50% Reduction in Platelet Count | 12 months | Subjects who achieved at least 50% reduction in platelet count from their baseline level across consecutive visits for at least 4 weeks and following 3 months of treatment. |
| Secondary | Percentage of Subjects With Normalization in Platelet Count | 12 months | Normalization was defined as platelet counts ≤400x10\^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment. |
| Secondary | Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was ≥600x10^9/L | 12 months | A response was defined as platelet counts to \<600x10\^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment. |
| Secondary | Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was <600x10^9/L | 12 months | A response was defined as platelet counts to \<600x10\^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment. |
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 | Percentage of Subjects Who Responded in Platelet Count | 12 months | Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects With at Least 50% Reduction in Platelet Count | 12 months | Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects With Normalization in Platelet Count | 12 months | Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was ≥600x10^9/L | 12 months | Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was <600x10^9/L | 12 months | Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment. | percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects Who Responded in Platelet Count | Anagrelide Hydrochloride | 67.9 | 95% Confidence Interval 53.7 to 80.1 | percentage of subjects | |
| Percentage of Subjects With at Least 50% Reduction in Platelet Count | Anagrelide Hydrochloride | 50.9 | 95% Confidence Interval 36.8 to 64.9 | percentage of subjects | |
| Percentage of Subjects With Normalization in Platelet Count | Anagrelide Hydrochloride | 45.3 | 95% Confidence Interval 31.6 to 59.6 | percentage of subjects | |
| Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was ≥600x10^9/L | Anagrelide Hydrochloride | 68.1 | 95% Confidence Interval 52.9 to 80.9 | percentage of subjects | |
| Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was <600x10^9/L | Anagrelide Hydrochloride | 66.7 | 95% Confidence Interval 22.3 to 95.7 | percentage of subjects |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anagrelide Hydrochloride | 53 | |
| Overall Study | COMPLETED | Anagrelide Hydrochloride | 42 | |
| Overall Study | NOT COMPLETED | Anagrelide Hydrochloride | 11 |
Source ClinicalTrials.gov
Adverse events68
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 Hydrochloride | 25 | 53 | 27 |
| other | EOSINOPHILIA | Blood and lymphatic system disorders | Anagrelide Hydrochloride | 3 | 53 | 3 |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | Anagrelide Hydrochloride | 4 | 53 | 4 |
| other | PALPITATIONS | Cardiac disorders | Anagrelide Hydrochloride | 20 | 53 | 23 |
| other | VERTIGO | Ear and labyrinth disorders | Anagrelide Hydrochloride | 4 | 53 | 6 |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | Anagrelide Hydrochloride | 4 | 53 | 5 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Anagrelide Hydrochloride | 5 | 53 | 6 |
| other | CONSTIPATION | Gastrointestinal disorders | Anagrelide Hydrochloride | 3 | 53 | 3 |
| other | DENTAL CARIES | Gastrointestinal disorders | Anagrelide Hydrochloride | 3 | 53 | 3 |
| other | DIARRHOEA | Gastrointestinal disorders | Anagrelide Hydrochloride | 17 | 53 | 20 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anagrelide Hydrochloride | ||
| Total, other adverse events | Anagrelide Hydrochloride | 53 | 53 |
| Total, serious adverse events | Anagrelide Hydrochloride | 15 | 53 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25160063 | RESULT |
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/NCT01214915
GET https://conductscience.org/api/trials/v1/NCT01214915/events?page=2