Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2004-004058-20 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Age related differences in response to a drug could arise from variation in pharmacokinetic (PK) and/or pharmacodynamic (PD) profiles between age groups. Whilst the efficacy and safety profile of anagrelide is well established through a well-documented clinical trial programme in patients of all ages, no formal studies have been carried out to investigate whether the PK profile of anagrelide and its metabolites is altered with age.
This study is designed to allow comparisons to be made in terms of pharmacokinetics of anagrelide and its metabolites between elderly (≥ 65 years) and young (18-50 years) ET patients
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Younger Participants (18-50 years) | Experimental |
| |
| Elderly Participants (≥65 years) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anagrelide hydrochloride | Drug | Anagrelide hydrochloride 0.5 mg per capsule; participants will be stable on an anagrelide treatment regimen and will take capsules from their own prescription except on the PK day when the participant specific anagrelide dose will be administered from a controlled study specific supply. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Agrylin | over 1 day | |
| Time of Maximum Plasma Concentration (Tmax) of Agrylin | over 1 day | |
| Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin | over 1 day | |
| Terminal Half-life (T 1/2) of Agrylin | over 1 day | |
| Total Clearance (CL/F) of Agrylin | over 1 day | |
| Volume of Distribution (Vz/F) of Agrylin | over 1 day | |
| Cmax of Active Metabolite | An active metabolite has therapeutic activity similar to the parent compound and must be considered in therapeutic pharmacokinetics. | over 1 day |
| Tmax of Active Metabolite | over 1 day | |
| AUC of Active Metabolite | over 1 day | |
| T 1/2 of Active Metabolite | over 1 day | |
| CL/F of Active Metabolite |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet Count | Platelet counts in patients with ET receiving Agrylin | over 1 day |
| Heart Rate | Heart rates in patients with ET receiving Agrylin |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospitl Del Mar | Barcelona | Spain | ||||
| Quintiles Hermelinen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22943924 | Derived | Besses C, Zeller W, Alvarez-Larran A, Coll R, Troy S, Purkayastha J, Martin P, Freitag C. Pharmacokinetics and tolerability of anagrelide hydrochloride in young (18 - 50 years) and elderly (>/= 65 years) patients with essential thrombocythemia. Int J Clin Pharmacol Ther. 2012 Nov;50(11):787-96. doi: 10.5414/CP201711. |
| Label | URL |
|---|---|
| FDA-approved Label | View source |
Not provided
The study comprised four phases: Screening (patients take their normal regimen of anagrelide), a run-in period (patients divided their normal anagrelide daily dose equally into two daily doses), Pharmacokinetics (PK) sampling day (patients take normal morning dose), and follow-up (patients were contacted by phone 30 days after PK visit).
Patients were between 18-50 years (young) and 65 or older (elderly) with a diagnosis of essential thrombocythemia (ET) and receiving a stable dose of anagrelide <=5mg/day for at least 4 weeks.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Agrylin (Young) | Anagrelide hydrochloride in ages 18-50 years |
| FG001 | Agrylin (Elderly) | Anagrelide hydrochloride in ages 65 and older |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Agrylin (Young) | Anagrelide hydrochloride in ages 18-50 years |
| BG001 | Agrylin (Elderly) | Anagrelide hydrochloride in ages 65 and older |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Plasma Concentration (Cmax) of Agrylin | PK population (defined as all patients with post-dose drug concentration data) | Posted | Geometric Mean | Standard Deviation | ng/ml | over 1 day |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Agrylin (Young) | Anagrelide hydrochloride in ages 18-50 years |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
Not provided
| ID | Term |
|---|---|
| D013920 | Thrombocythemia, Essential |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D013922 | Thrombocytosis |
Not provided
Not provided
| ID | Term |
|---|---|
| C021139 | anagrelide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| anagrelide hydrochloride | Drug | Anagrelide hydrochloride 0.5 mg per capsule; participants will be stable on an anagrelide regimen and will take capsules from their own prescription except on the PK day when the participant specific anagrelide dose will be administered from a controlled study specific supply. |
|
| over 1 day |
| Vz/F of Active Metabolite | over 1 day |
| over 1 day |
| Systolic Blood Pressure | Systolic blood pressures in patients with ET receiving Agrylin | over 1 day |
| Diastolic Blood Pressure | Diastolic blood pressures in patients with ET receiving Agrylin | over 1 day |
| Luleå |
| Sweden |
| Uppsala Akademiska Sjukhus | Uppsala | 75185 | Sweden |
| Quintiles AB Phase I Unit | Uppsala | Sweden |
| Belfast City Hospital | Belfast | United Kingdom |
| FDA Recall Information | View source |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
|
| Secondary | Platelet Count | Platelet counts in patients with ET receiving Agrylin | Safety population (defined as all patients who received study treatment) | Posted | Mean | Standard Deviation | x 1,000,000,000/L | over 1 day |
|
|
|
| Secondary | Heart Rate | Heart rates in patients with ET receiving Agrylin | Safety population | Posted | Mean | Standard Deviation | beats/min | over 1 day |
|
|
|
| Primary | Time of Maximum Plasma Concentration (Tmax) of Agrylin | PK population | Posted | Geometric Mean | Standard Deviation | hours | over 1 day |
|
|
|
|
| Primary | Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin | PK population | Posted | Geometric Mean | Standard Deviation | ng.h/ml | over 1 day |
|
|
|
|
| Primary | Terminal Half-life (T 1/2) of Agrylin | PK population | Posted | Geometric Mean | Standard Deviation | hours | over 1 day |
|
|
|
|
| Primary | Total Clearance (CL/F) of Agrylin | PK population | Posted | Geometric Mean | Standard Deviation | L/h | over 1 day |
|
|
|
|
| Primary | Volume of Distribution (Vz/F) of Agrylin | PK population | Posted | Geometric Mean | Standard Deviation | L | over 1 day |
|
|
|
|
| Primary | Cmax of Active Metabolite | An active metabolite has therapeutic activity similar to the parent compound and must be considered in therapeutic pharmacokinetics. | PK population | Posted | Geometric Mean | Standard Deviation | ng/ml | over 1 day |
|
|
|
|
| Primary | Tmax of Active Metabolite | PK population | Posted | Geometric Mean | Standard Deviation | hours | over 1 day |
|
|
|
|
| Primary | AUC of Active Metabolite | PK population | Posted | Geometric Mean | Standard Deviation | ng.h/ml | over 1 day |
|
|
|
|
| Primary | T 1/2 of Active Metabolite | PK population | Posted | Geometric Mean | Standard Deviation | hours | over 1 day |
|
|
|
|
| Primary | CL/F of Active Metabolite | PK population | Posted | Geometric Mean | Standard Deviation | L/h | over 1 day |
|
|
|
|
| Primary | Vz/F of Active Metabolite | PK population | Posted | Geometric Mean | Standard Deviation | L | over 1 day |
|
|
|
|
| Secondary | Systolic Blood Pressure | Systolic blood pressures in patients with ET receiving Agrylin | Safety population | Posted | Mean | Standard Deviation | mmHg | over 1 day |
|
|
|
| Secondary | Diastolic Blood Pressure | Diastolic blood pressures in patients with ET receiving Agrylin | Safety population | Posted | Mean | Standard Deviation | mmHg | over 1 day |
|
|
|
| 0 |
| 12 |
| 3 |
| 12 |
| EG001 | Agrylin (Elderly) | Anagrelide hydrochloride in ages 65 and older | 0 | 12 | 0 | 12 |
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| D001791 | Blood Platelet Disorders |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006474 | Hemorrhagic Disorders |
| 12 hours post-dose |
|
| 1 hour post-dose |
|
| 1.5 hours post-dose |
|
| 2 hours post-dose |
|
| 4 hours post-dose |
|
| 6 hours post-dose |
|
| 8 hours post-dose |
|
| 12 hours post-dose |
|
| 1.0 hours post-dose |
|
| 1.5 hours post-dose |
|
| 2 hours post-dose |
|
| 4 hours post-dose |
|
| 6 hours post-dose |
|
| 8 hours post-dose |
|
| 12 hours post-dose |
|
| 1 hour post-dose |
|
| 1.5 hours post-dose |
|
| 2 hours post-dose |
|
| 4 hours post-dose |
|
| 6 hours post-dose |
|
| 8 hours post-dose |
|
| 12 hours post-dose |
|