AOP 03-007 - ANAHYDRET Study

A single blind, multi-centre, randomised multinational Phase III Study to compare the Efficacy and Tolerability of Anagrelide vs Hydroxyurea in Patients with Essential Thrombocythaemia.

Main

Overview
Contact 		Activity Sheet:

Screening day month

 

0

7

14

21

28

2

3

4

5

6

8

10

12

Fu4)

Informed Consent

X

Pregnancy Test 1)

X

X

X

X

X

X1)

X1)

X1)

X1)

X1)

Med. History,
Vital signs

X
X

compl. Physic. Exam.

X

X

CBC
differential BC
platelet count

X
X
X

X
X
X

X
X
X

X
X
X

X
X
X

X
X
X

X
X
X

X
X
X

X
X
X

X
X
X

X
X
X

X
X
X

X
X
X

X
X
X

X
X
X

compl. Blood chem.2)

X

X

Electrolytes3)

X

X

Normotest
PTT
Fibrinogen

X
X
X

X
X
X

ET tel. complications

X

X

X

X

X

X

X

X

Disease progress./AEs

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Compliance

X

X

X

X

X

X

Dose modification

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Concom. Medication

X

X

X

X

X

Quality of Life

X

X

X

Patient Diary

X

X

X

X

X

X

X

X

X

X

1) Pregnancy test has to be carried out monthly up to 12 months in women in childbearing age, patient has to be advised that adequate contraception is mandatory.
2) must include the following: BUN, Creatinin, Glucose, Albumine, Total bilirubin, Alkaline phospatase, AST, ALT, Total protein, Calcium, Phosphorus, LDH
3) must include the following: Sodium, Potassium, Chloride, Magnesium
4) Follow up: Assessment according to discretion of investigator (3 months intervals suggested)


See also:
Study Protocol
Appendix I