Trial · NCT00413634

The Pharmacokinetics of Anagrelide in Elderly and Young Patients With Essential Thrombocythaemia (ET)

NCT00413634, Phase 2, Completed, Shire; results first posted 2009-06-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Pharmacokinetics of Anagrelide in Elderly and Young Patients With Essential Thrombocythaemia (ET). Trials, record NCT00413634. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00413634

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Pharmacokinetics of Anagrelide in Elderly and Young Patients With Essential Thrombocythaemia (ET)
NCT number: NCT00413634
Status: Completed
Phases: Phase 2
Enrollment: 24 participants, actual
Lead sponsor: Shire
Conditions: Essential Thrombocythaemia
Interventions: anagrelide hydrochloride, anagrelide hydrochloride
First posted: 2006-12-20
Last updated: 2021-06-29
Other registries' IDs: eudract:2004-004058-20
Results first posted: 2009-06-02

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Plasma Concentration (Cmax) of Agrylin	over 1 day
Primary	Time of Maximum Plasma Concentration (Tmax) of Agrylin	over 1 day
Primary	Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin	over 1 day
Primary	Terminal Half-life (T 1/2) of Agrylin	over 1 day
Primary	Total Clearance (CL/F) of Agrylin	over 1 day
Primary	Volume of Distribution (Vz/F) of Agrylin	over 1 day
Primary	Cmax of Active Metabolite	over 1 day	An active metabolite has therapeutic activity similar to the parent compound and must be considered in therapeutic pharmacokinetics.
Primary	Tmax of Active Metabolite	over 1 day
Primary	AUC of Active Metabolite	over 1 day
Primary	T 1/2 of Active Metabolite	over 1 day

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Plasma Concentration (Cmax) of Agrylin	over 1 day	PK population (defined as all patients with post-dose drug concentration data)	ng/ml	GEOMETRIC_MEAN
SECONDARY	Platelet Count	over 1 day	Safety population (defined as all patients who received study treatment)	x 1,000,000,000/L	MEAN
SECONDARY	Heart Rate	over 1 day	Safety population	beats/min	MEAN
PRIMARY	Time of Maximum Plasma Concentration (Tmax) of Agrylin	over 1 day	PK population	hours	GEOMETRIC_MEAN
PRIMARY	Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin	over 1 day	PK population	ng.h/ml	GEOMETRIC_MEAN
PRIMARY	Terminal Half-life (T 1/2) of Agrylin	over 1 day	PK population	hours	GEOMETRIC_MEAN
PRIMARY	Total Clearance (CL/F) of Agrylin	over 1 day	PK population	L/h	GEOMETRIC_MEAN
PRIMARY	Volume of Distribution (Vz/F) of Agrylin	over 1 day	PK population	L	GEOMETRIC_MEAN
PRIMARY	Cmax of Active Metabolite	over 1 day	PK population	ng/ml	GEOMETRIC_MEAN
PRIMARY	Tmax of Active Metabolite	over 1 day	PK population	hours	GEOMETRIC_MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group84

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Maximum Plasma Concentration (Cmax) of Agrylin	Agrylin (Young)		2.66	Standard Deviation 0.99	ng/ml
Maximum Plasma Concentration (Cmax) of Agrylin	Agrylin (Elderly)		3.63	Standard Deviation 1.44	ng/ml
Platelet Count	Agrylin (Young)	Baseline	488.8	Standard Deviation 167.4	x 1,000,000,000/L
Platelet Count	Agrylin (Elderly)	Baseline	548.5	Standard Deviation 278.7	x 1,000,000,000/L
Platelet Count	Agrylin (Young)	2 hours post-dose	487.9	Standard Deviation 168.1	x 1,000,000,000/L
Platelet Count	Agrylin (Elderly)	2 hours post-dose	539.2	Standard Deviation 258.6	x 1,000,000,000/L
Platelet Count	Agrylin (Young)	12 hours post-dose	473.2	Standard Deviation 146.0	x 1,000,000,000/L
Platelet Count	Agrylin (Elderly)	12 hours post-dose	540.3	Standard Deviation 263.6	x 1,000,000,000/L
Heart Rate	Agrylin (Young)	Baseline	74.0	Standard Deviation 9.6	beats/min
Heart Rate	Agrylin (Elderly)	Baseline	70.3	Standard Deviation 8.4	beats/min

1 to 10 of 84Source ClinicalTrials.gov

See all 84 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Agrylin (Young)	12
Overall Study	STARTED	Agrylin (Elderly)	12
Overall Study	COMPLETED	Agrylin (Young)	12
Overall Study	COMPLETED	Agrylin (Elderly)	12
Overall Study	NOT COMPLETED	Agrylin (Young)	0
Overall Study	NOT COMPLETED	Agrylin (Elderly)	0

Source ClinicalTrials.gov

Adverse events8

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	Nasopharyngitis	Infections and infestations	Agrylin (Young)	1	12	1
other	Nasopharyngitis	Infections and infestations	Agrylin (Elderly)	0	12	0
other	Urinary tract infection	Infections and infestations	Agrylin (Young)	1	12	1
other	Urinary tract infection	Infections and infestations	Agrylin (Elderly)	0	12	0
other	Headache	Nervous system disorders	Agrylin (Young)	1	12	1
other	Headache	Nervous system disorders	Agrylin (Elderly)	0	12	0
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	Agrylin (Young)	1	12	1
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	Agrylin (Elderly)	0	12	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Agrylin (Young)
Total, all-cause mortality	Agrylin (Elderly)
Total, other adverse events	Agrylin (Young)	3	12
Total, other adverse events	Agrylin (Elderly)	0	12
Total, serious adverse events	Agrylin (Young)	0	12
Total, serious adverse events	Agrylin (Elderly)	0	12

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22943924	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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Agrylin (Young) vs Agrylin (Elderly): serious adverse events

Source 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00413634

GET https://conductscience.org/api/trials/v1/NCT00413634/results?page=2

API reference For AI assistants