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Trial record 7 of 227 for:    "essential thrombocythemia"

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

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ClinicalTrials.gov Identifier: NCT00413634
Recruitment Status : Completed
First Posted : December 20, 2006
Results First Posted : June 2, 2009
Last Update Posted : June 12, 2014
Sponsor:
Information provided by:
Shire

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Essential Thrombocythaemia
Intervention: Drug: anagrelide hydrochloride

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
Agrylin (Young) Anagrelide hydrochloride in ages 18-50 years
Agrylin (Elderly) Anagrelide hydrochloride in ages 65 and older

Participant Flow:   Overall Study
    Agrylin (Young)   Agrylin (Elderly)
STARTED   12   12 
COMPLETED   12   12 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Agrylin (Young) Anagrelide hydrochloride in ages 18-50 years
Agrylin (Elderly) Anagrelide hydrochloride in ages 65 and older
Total Total of all reporting groups

Baseline Measures
   Agrylin (Young)   Agrylin (Elderly)   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   24 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   12   0   12 
>=65 years   0   12   12 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.2  (8.4)   69.2  (3.0)   54.2  (16.5) 
Gender 
[Units: Participants]
     
Female   9   8   17 
Male   3   4   7 
Region of Enrollment 
[Units: Participants]
     
Germany   5   10   15 
United Kingdom   2   1   3 
Spain   1   1   2 
Sweden   2   0   2 
Serbia   2   0   2 


  Outcome Measures

1.  Primary:   Maximum Plasma Concentration (Cmax) of Agrylin   [ Time Frame: over 1 day ]

2.  Primary:   Time of Maximum Plasma Concentration (Tmax) of Agrylin   [ Time Frame: over 1 day ]

3.  Primary:   Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin   [ Time Frame: over 1 day ]

4.  Primary:   Terminal Half-life (T 1/2) of Agrylin   [ Time Frame: over 1 day ]

5.  Primary:   Total Clearance (CL/F) of Agrylin   [ Time Frame: over 1 day ]

6.  Primary:   Volume of Distribution (Vz/F) of Agrylin   [ Time Frame: over 1 day ]

7.  Primary:   Cmax of Active Metabolite   [ Time Frame: over 1 day ]

8.  Primary:   Tmax of Active Metabolite   [ Time Frame: over 1 day ]

9.  Primary:   AUC of Active Metabolite   [ Time Frame: over 1 day ]

10.  Primary:   T 1/2 of Active Metabolite   [ Time Frame: over 1 day ]

11.  Primary:   CL/F of Active Metabolite   [ Time Frame: over 1 day ]

12.  Primary:   Vz/F of Active Metabolite   [ Time Frame: over 1 day ]

13.  Secondary:   Platelet Count   [ Time Frame: over 1 day ]

14.  Secondary:   Heart Rate   [ Time Frame: over 1 day ]

15.  Secondary:   Systolic Blood Pressure   [ Time Frame: over 1 day ]

16.  Secondary:   Diastolic Blood Pressure   [ Time Frame: over 1 day ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Timothy Whitaker, M.D.
Organization: Shire
e-mail: twhitaker@shire.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Timothy Whitaker, M.D., Shire
ClinicalTrials.gov Identifier: NCT00413634     History of Changes
Other Study ID Numbers: SPD422-203
2004-004058-20 ( EudraCT Number )
First Submitted: December 19, 2006
First Posted: December 20, 2006
Results First Submitted: March 5, 2009
Results First Posted: June 2, 2009
Last Update Posted: June 12, 2014