TRIALS PERFORMED

Building Bridges

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   

System

Indication

Phase

R*

Specification

No. of centres**

No. of patients**

Countries involved***

****

CARD

Cardiac dysrhythmia

IV

 

 

08

100

CR, (G)

C

CARD

Heart failure

IV

 

 

05

60

CR, (G)

C

CARD

MI acute, fibrinolysis

III

R

18 PCI sites

90

ET [LoE]

CR, HU (WW)

C

ENDO

Acromegaly

III

R

 

02

20

CR, (EU)

C

ENDO

Acromegaly

III

R

 

03

20

CR, (EU)

ļ

ENDO

Small gestation age

IV

 

limited to site set-up

11

00

CR,  SK, (EU)

C

GAST

Colitis ulcerosa

III

 

 

10

60

CR, SK, (G)

C

GYN

In-vitro Fertilisation

IIa

R

donor stimulation

01

20

CR (EU)

C

GYN

In-vitro Fertilisation

II

R

uterine contractions

02

35

CR, (EU)

C

GYN

In-vitro Fertilisation

II

R

uterine contractions

02

30

CR, (EU)

ļ

GYN

Hormonal Replacement 1

III

R

prior to guideline

20

200

CR, (G)

C

GYN

Hormonal Replacement 2

III

R

CPMP/EWP/021/97

20

150

CR, (G)

C

GYN

Hormonal Replacement 3

III

R

CPMP/EWP/021/97

15

150

CR, (G)

C

GYN

Hormonal Replacement 4

III

R

CPMP/EWP/021/97

20

160

CR, (G)

C

GYN

Hormonal Replacement 5

IV

R

CPMP/EWP/021/97

40

280

CR, PL, (G)

C

GYN

Hormonal Replacement 6

IV

R

CPMP/EWP/021/97

45

400

CR, PL

C

GYN

Mastalgia

III

R

phyto-pharm. IMP

01

100

CR

C

GYN

Osteoporosis treatment

III

 

 

01

50

SK, (G)

C

GYN

Postmenopausal syndrome

III

R

phyto-pharm. IMP

20

160

CR

C

GYN

Premenstrual syndrome

III

R

phyto-pharm. IMP

20

300

CR

C

INT

Anemia

III

 

pre-dialysis patients

15

80

CR, SK (EU)

ļ

INT

Diabetes mellitus type II

II

R

first long-term appl.

05

20

CR (EU)

C

INT

Hypertension

IV

 

renal transplant pat.

01

50

CR (EU)

C

NEUR

Dementia 1

III

 

DAT

08

120

CR, SK (EU)

C

NEUR

Dementia 2

III

R

DAT and MID

08

140

CR, SK (EU)

C

NEUR

Dementia 3

III

R

DAT and MID

10

140

CR, SK (EU)

C

NEUR

Mild Cognitive Impairment

III

 

phyto-pharm. IMP

25

ET [ST]

CR, SK

C

NEUR

Depression

III

R

«pain enriched»

10

100

CR, SK (EU)

C

NEUR

Multiple Sclerosis 1

IV

 

data auditing PASS

10

200

CR

C

NEUR

Multiple Sclerosis 2

IIb

R

MRI-controlled

06

ET [Saf]

CR, (WW)

C

ONCO

Renal Cell Carcinoma

II

 

vaccination

04

40

CR, A

ļ

OPHTH

Conjuctivitis

III

 

 

05

100

CR

C

PULM

Anti-infective therapy

IV

 

pneumonia

09

90

CR, HU (EU)

C

PULM

Bronchitis

PAS

 

children

02

100

G

C

PULM

COPD

IV

 

COPD subgroup

80

500

CR, PL, HU (G)

C

RHEU

Osteoarthritis

PAS

 

knee/ hip

240

1.700

CR

C

SEX

Premature ejaculation

III

 

 

05

30

CR, PL

ļ

SURG

Anti-infective prophylaxis

III

 

elective surgery

01

20

CR, (EU)

C

UROL

Prostate cancer 1

III

R

 

05

35

CR, (G)

C

UROL

Prostate cancer 2

III

R

 

20

90

CR, PL, (EU)

C

UROL

Urinary incontinence 1

IV

 

long-term 1 y

15

190

CR, SK, (EU)

C

UROL

Urinary incontinence 2

IV

R

 

10

100

CR

C

UROL

Urinary incontinence 3

III

R

long-term 1 y

10

100

CR, (EU)

C

UROL

Urinary incontinence 4

III

R

 

15

140

CR, SK, (EU)

C

UROL

Urinary incontinence 5

I

R

monitoring, auditing

01

06

CR

C

UROL

Urinary incontinence 6

III

R

 

06

60

CR, (EU)

C

UROL

Urinary incontinence 7

III

R

children

05

30

CR, SK, (EU)

C

 

 

 

 

 

 

 

 

 

*

Repeat business (more than one trial by the same sponsor), overall  repeat ratio about 60%

**

Share in CEE- countries managed by PHAMOS

ET= early terminated due to lack of efficacy LoE, Safety Saf or by strategic reasons ST

***

Countries managed by PHAMOS, in brackets other countries not managed by PHAMOS but by sponsor or other CROs (EU stands for more than one other EU country, WW for global studies)

****

Status as of JUL 2009: Completed, in Preparation, ļ ongoing

Sponsors we have been working for:

Apogepha, Bionorica, Bioforce, Boehringer Ingelheim, Dentinox, Falk Pharma, Ferring, Hexal Biotech, Ipsen, Jenapharm, Lilly, Madaus, Merckle, Novartis, NovoNordisk, Parke Davis, Plantamed, Plethora Solutions, Sandoz, Schering, Schwabe, Serono, S&K Pharma, Slovakopharma, SKB, Takeda, Trimed Biotech, Wyeth, Yamanouchi