STUDI CLINICI

 

Dal 1996 mi occupo di ricerca clinica, ed ho partecipato come sperimentatore a oltre un centinaio di studi clinici internazionali sponsorizzati.

 

Nel settore dell'urologia, protocolli clinici riguardanti in particolar modo l'ipertrofia prostatica benigna, il tumore prostatico, il tumore vescicale superficiale.

 

Nel settore dell'andrologia, protocolli clinici riguardanti il miglioramente della fertilità maschile e protocolli clinici relativi gli inibitori della Pde5.

 

Nel settore cardiologico, studio sulla bivalirudina somministrata in ambulanza nei pazienti con STEMI avviati ad angioplastica primaria.

 

Elenco dei clinical trial a cui ho partecipato come Clinical Research Coordinator (CRC):

  

* Pfizer:

148-364: “A double-blind, randomised, placebo-controlled, parallel group, multicentre study to assess the efficacy and safety of fixed doses of sildenafil administered for three months to male patients with erectile dysfunction.”

Pfizer, Central Research, 1996 

 

* Pfizer:

148-370” An open, non comparative study to assess the long-term safety and efficacy of Sildenafil taken as required by male patients with erectile dysfunction” 

Pfizer, Central Research

 

* Pfizer:

148-373 “ An open, non comparative extension study of sildenafil in patients with erectile dysfunction” 

Pfizer, Central Research

 

* Pfizer:

"An open study to assess the feasibility of switching patients currently using intra cavernosal injections of alprostadil to treat erectile dysfunction to treatment with viagra (sildenafil) 

(SDN-NY-97-001) (studio sottoposto a audit)

 

* Pfizer:

" A double-blind, randomized, fixed-dose, placebo controlled study to assess the efficacy and safety of sildenafil in preventing erectile dysfunction in patient who have undergone a bilateral nerve sparing radical prostatectomy"



 

* Bayer:

"An open, multi-centre, flexible dose, twenty six week treatment extension of study Bay 38-9456/10128 to assess the safety and tollerability of 5 mg, 10 mg, 20 mg Bay 38-9456, a phosphodiesterase type V inhibitor, in the treatment of male patients with erectile dysfunction"

(bay 38-9456   remedy 10128) (studio sottoposto a audit)

 

* Bayer:

"A randomized, double-blind, placebo and active (Viagra) controlled, multi-centre, fixed-dose, parallel group study to investigate the efficacy and safety of the phosphodiesterase type V inhibitor BAY 38/9456 in males with erectile dysfunction"

(bay 38-9456   remedy 10194)

 

* Takeda:

"Studio multicentrico europeo, doppio ceco, controllato con placebo, randomizzato, a gruppi paralleli sulla valutazione della efficacia di apomorfina 4 mg in pazienti maschi affetti da disfunzione erettile e sul confronto della tollerabilità di due dosaggi (2 e 4 mg) di apomorfina"
(APO-EC501) (studio sottoposto ad audit)

 

* Takeda:

"Studio multicentrico europeo, in aperto con apomorfina compresse sublinguali nel trattamento della disfunzione erettile

(APO-EC502) 

 

* Eli Lilly:

"A two year, open-label study of on demand therapy with IC351 for the treatment of male erectile dysfunction"

(H6D-MC-LVBL)

 

* Eli Lilly:

"A randomized, double-blind, placebo controlled study of IC351 compared with sildenafil for treatment of patients with male erectile dysfunction

(H6D-MC-LVBO)

 

* TAP:

"A phase III study evaluating the safety and efficacy of Uprima (apomorphine HCL) compared to Viagra (sildenafil citrate) 25, 50, or 100 mg in the treatment of male erectile dysfunction"

(Tap 99-M099) (studio sottoposto a audit)

 

* Pfizer:

" A double-blind, randomized, placebo controlled, parallel group, multicenter, flexible dose escalation study to assess the efficacy and safety of Viagra (sildenafil) administered as required to male patients with type I diabetes and erectile dystunction"

(SDN-NY-98-002)

 

* Pfizer:

"A double-blind, randomized, placebocontrolled, parallel group, multicenter, flexible dose escalation study to assess the efficacy and safety of viagra in the treatment of erectile dysfunction following radical prostatectomy"

(SND-F-98-002)

 

* Pfizer:

"Phase II double-blind, placebo-controlled, parallel-group, multicentre, dose-response study to assess the efficacy, safety and toleration of up to 28 doses of uk-369,003 (taken as needed over a period not exceeding 8 weeks) in subjects with erectile dysfunction"

protocol A371-1007-0054

 

* Bayer:

"A randomized, placebo-controlled, double-blind, multi-centre, flexible-dose, parallel group study to investigate the efficacy and safety of vardenafil given on demand in comparison with placebo in males with erectile dysfunction"

protocol: Bay 38-9456/10769

 

* Astra:

" A double-blind parallel study of two different starting doses in the titration of muse and actis for the treatment of erectile dysfunction"

 

* Pfizer:

"A double blind, randomized, fixed-dose, placebo controlled study to assess the efficacy and safety of sildenafil in preventing erectile disfunction in patient who have a bilateral nerve sparing radical prostatectomy."

 

* Abbott Laboratories:

"A double-blind, placebo-controlled, dose optimization, safety and efficacy study of 2 and 3 mg UPRIMA tablets inthe treatment of male erectiledysfunction in men with controlled hypertension" 

protocol: W01-365 (studio sottoposto a audit)

 

 

* Eli Lilly:

"A randomized,crossover,open-label study of IC351 administered to patients with erectile dysfunction assessing patient preference for either an "on demand" or a "scheduled" treatment regimen" 

protocol: H6D-MC-LVEM

 

* Eli Lilly:

"A randomized, double-blind, placebo controlled study of efficacy and safety of IC351 administred "on demand" to patients with erectile dysfunction following bilateral nerve-sparing radical retropubic prostatectomy" 



 

* Pfizer:

"An open label, randomised, flexible dose, crossoverstudy to assess the comparative efficacy and safety of sildenafil citrate and apomorphine hydrochloride in men with erectile dysfunction"

protocol: A1481116

 

* Bayer:

"A randomized double-blind multi center parallel group three month study to compare the tolerability and efficacy of flexible dose vardenafil versus placebo in men with depression and erectile dysfunction"

protocol: Bay 38-9456/10621

 

* GSK:

"A randomized, double-blind, parallel-group, placebo-controlled study evaluating the efficacy and safety of vardenafil administered for12 weeks in a flexible-dose regimen compared to placebo in subjectwith male erectile dysfunction solely secondary to traumaticspinal cord injury"

protocol: SB-782528-002

 

* GSK:

"A randomised, double-blind, parallel-group, placebo-controlled study evaluating the efficacy, safety and reliability of 10 mg vardenafil administred for 12 weeks compared to placebo in subject with erectil dysfunction and a demostrated successful first response to 10 mg vardenafil"

protocol: SB-782528-022 (studio sottoposto a audit)

    

* Bayer:

" A randomized double-blind multicenter parallel group three month study to compare the tolerability and efficacy of flexible dose vardenafil versus placebo in men with depression and erectile dysfunction"

protocol: Bay 38-9456/10621

 

* Bioxell: "A randomized, double blind, placebo controlled, parallel group study to determinate the effect of BXL-628 in patient with benign prostatic hyperplasia (BPH)

protocol: BXL-628 02 12

 

* Pfizer:

" A phase III, randomized, double-blind, placebo controlled, flexible dose, multicenter study to evaluate the efficacy, safety and toleration of oral sildenafil administrered for 12weeksto post-menopausal women receiving hormone replacement therapy and who have been diagnosed with female sexual arousal disorder"

protocol: A1481127

 

* Bayer:

" A randomised, active-controlled, double-blind, multi-centre, flexible-dose, parallel group study to investigate the efficacy and safety of vardenafil given on demand in comparison with sildenafil in males with erectile dysfunction"

protocol: BAY 38-9456/100446

 

*Bayer:

"A randomized, double blind, double dummy, parallel group, multi-center study to investigate the time to onset of action of 10 mg and 20 mg of vardenafil compared to placebo in males with erectile dysfunction"

protocol: Bay 38-9456/100492

        

* Glaxo:

"A randomized, double blind, placebo controlled, parallel group study of the efficacy and safety of dutasteride 0.5 mg administred once daily for four years to reduce the risk of biopsy detectable prostate cancer"

protocol: ARI 40006

 

* Merck Sharp&Dohme:

"A double-blind, randomized, placebo controlled, multicenter study to evaluate the effect of Refocoxib in decreasing the risck of prostate cancer (VIP study)"

protocol: MK-0966

 

* Eli Lilly:

"A multicenter open-label study to determinate treatment preference of tadalafil or sildenafil citrate in the oral treatment of erectile dysfunction"

protocol: H6D-MC-LVFL (studio sottoposto ad audit)

 

* Bayer:

"A randomised, open-label, multicenter, parallel group study to investigate the efficacy and safety of vardenafil (10 mg, taken one hour prior to sexual activity) in   comparison to tadalafil (10 mg, taken 24
hours prior to sexual activity) in males with erectile dysfunction and
diagnosis of diabetes mellitus and/or hypertension and/or hyperlipidemia"

protocol: Bay 38-9456/10893

 

* Glaxo:

"A randomised, double-blind, pasrallel group study to investigate the efficacy and     safety of treatment with dutasteride (0,5 mg) and tamsulosin (0,4 mg), administered once daily for 4 years, alone and in
combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic binign prostatic hyperplasia."      

protocol : ARI40005

 

* Eli Lilly:
" Studio osservazionale sulla disfunzione erettile (EDOS)".

protocol H6D-EW-LVFC

 

* Pfizer:

" A phase 2b, multi-center, double blind, placebo controlled, parallel group dose response study to assess the efficacy and safety of oral UK-390,957 in men with premature ejaculation."

protocol A3871027

 

* Bayer:

"Prospective, randomized, double-blind, comparison of ciprofloxacin extended-relese 1000 mg tablets given as two different prophylactic dosing regimes (regimens I: single dose ciprofloxacin MR 1000 mg or regimen II: multiple dose ciprofloxacin MR 1000 mg once daily for 3 days) for the prevention of post-operative infectious complications in patients undergoing transrtectal needle biopsy of the prostate."

protocol: Bay 1000588 (studio sottoposto ad audit)

 

* Pfizer:

“ A phase 2 multi-center, open label long term extension trial to assess the safety of oral UK-390,957 administered as required in adult men with premature ejaculation”

protocol A3871028

 

* Glaxo:

"A 4 week randomised, double-blind, duble-dummy, parallel-group, active-controlled study evaluating the efficacy of 10 mg vardenafil versus 10 mg tadalafil when intercourse is attempted within 45 minutes of administration in subjects with mild/moderate to
severe erectile dysfunction"

protocol: VAR 100447

 

* Schwarz:

"A phase 3, parallel group, randomized, double-blind, double-dummy, placebo and active-controlled multicenter trial to investigate the efficacy, tolerability and safety of fesotorodine sustained release in subjects with overactive bladder syndrome"

protocol: SP583

 

* Bioxell:

"A randomized, double blind, placebo controlled, parallel-group study to determinate the effect of BXL-628in post-menopausal women with Overactive Bladder (OAB)"

protocol: BXL-628 02 13

 

* Johnson&Johnson:

"A placebo-controlled, double-blind, randomized, parallel-group study of the efficacy and safety of dapoxetine in the treatment of subjects with premature ejaculation"

protocol: R096769-PRE-3001

 

* Eli Lilly:

"A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multinational Study to Evaluate the Efficacy and Safety of Daily Tadalafil for 12 Weeks in Men with Signs and Symptoms of Benign Prostatic Hyperplasia”

protocol: H6D-MC-LVHJ

 

* Bayer:

" A randomized, double-blind, double-dummy, multicenter, parallel group study to compare the tollerability and efficacy of once daily vardenafil versus vardenafil PRN versus placebo in men immediately after nerve-sparing prostatectomy for improving erectile function" REINVENT

protocol: Bay 38-9456/11336

 

* IPSEN PHARMA:
“Studio internazionale, multicentrico, a gruppi paralleli, in doppio cieco,
controllato da placebo, in fase IIIb, per valutare l’efficacia e la sicurezza
del Testim Gel in combinazione con un inibitore della fosfodiesterasi di tipo 5 (tadalafil), in pazienti di sesso maschile con livelli di testosterone
sierici al basale basso o “borderline” e disfunzione erettile”

protocol : 2005-005060-02

 

* Bioxell:

"A randomized, double blind, double dummy, placebo controlled, parallel-group study to determinate the effect of BXL-628 in monotherapy and in combination with tamsulosin in patients with benign prostatic hyperplasia"

protocol BXL628 02 14

 

* Bioxell:

"A randomized, double blind, placebo controlled, parallel-group study to determinate the effect of BXL-628 in patients with Chronic Non-Bacterial Prostatitis (category III Chronic Pelvic Pain Syndrome, CP/CPPS) protocol BXL628 02 15

 

* Eli Lilly:

“A randomized, double-blind, placebo controlled, parallel design, 5 group, multinational study to evaluate the efficacy, dose response and safety to tadalafil once-a-day dosing for 12 weeks in men with signs and symtoms of benign prostatic hyperplasia”

protocol: H6D-MC-LVHG

 

* GP-Pharm S.A:

" Efficacy and safety of a new Leuprolide acetate 3.75 mg depot formulation, GP-Pharm SA, when given as palliative treatment to prostate cancer patients" open-label, multiple dose, efficacy, safety and pharmacokinetic study"

protocol: CRO-04-62

 

* Recordati:

“Evaluation of the efficacy and safety of silodosin vs. tamsulosin and
placebo in the treatment of the signs and symptoms of benign prostatic
hyperplasia. Multicentre, randomised, double-blind, controlled trial with an optional long-term open label extension phase. KMD3213-IT-CL0215"
protocol: 2005-005665-11

 

* Amgen:

“A randomized, double blind, placebo-controlled, multi-center phase 3 study of Denosumab on prolonging bone metastasis-free survival in men with hormone-refractory prostate cancer”
protocol: 2005-0147

 

 

* Schering AG, Berlino:

"Double blind placebo controlled, randomized study of the effects of co-administering testosterone with PDE V inhibitor in ED patients non responders to PDE V inhibitors alone”

protocol: 2005-000852-34

 

* Bioxell:

"A randomised, double blind, placebo controlled, parallel group, multi-centre, phase 2b study, to determine the effect of BXL628 in women with detrusor overactivity”

protocol: BXL628 02 16

 

* Bioxell:

“A randomized, double blind, placebo controlled, parallel group study to determine the effect of Elocalcitol on sperm parameters in infertile male patients”

protocol: BXL628 02 17

 

* Astellas Pharma:

“Studio osservazionale prostata ST.O.P. L’importanza del monitoraggio     del paziente con carcinoma prostatico in terapia ormonale”

protocol: IT001

 

* Astra Zeneca:

“A phase III, randomised, double-blind study to assess the efficacy and safety of 10 mg ZD4054 versus placebo in patients with hormone-resistant prostate cancer and bone metastasis who are pain free or mildly symptomatic”

protocol: D4320C00014

 

* Astra Zeneca:

“A phase III, randomized, placebo-controlled, double-blind study to assess the efficacy and safety of once-daily orally administered ZD4054 10 mg in Non metastatic hormone-resistant prostate cancer patients”

protocol: D4320C00014

 

* Aeterna Zentaris:

“Cetrorelix pamoate (AEZS-102) in patients with sympotamatic BPH: double-blind placebo-controlled efficacy study”

protocol: AEZS-102-036

 

* Eli Lilly:

“A Comparison of Psychosocial Outcomes following Tadalafil Once a Day or PDE5 Inhibitor As Needed in Men with Erectile Dysfunction” 
protocol: H6D-CR-S024

 

* Merck Sharp & Dohme: “A phase II randomized, double-blind, placebo-controlled clinical trial to study the efficacy the effective and safety of bicalutamide with or without Deforolimus in men with asymptomatic, metastatic castrate-resistant prostate cancer”
protocol: MK8669-002

 

* Eli Lilly:

“A randomized, double-blind, placebo-controlled, parallel study to assess the efficacy and safety of tadalafil (LY450190) once a day in subjects with erectile dysfunction who are naïve to PDE5 inhibitors”

protocol: H6D-MC-LVHX

 

* Eli Lilly:

“A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil 2.5 and 5 mg Once Daily Dosing for 12 Weeks for the Treatment of Erectile Dysfunction and Signs and Symptoms of Benign Prostatic Hyperplasia in Men with Both Erectile Dysfunction and Benign Prostatic Hyperplasia” protocol: H6D-MC-LVHR

 

* Ferring:

“A dose-finding, multi-centre, double-blind, randomised, parallel, placebo-controlled trial to investigate efficacy and safety of degarelix in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). FE 200486 CS32"

protocol: 2009-012325-11

 

* Ferring:

“An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One Cycle in Patients with Prostate Cancer Requiring Androgen Deprivation Therapy” FE 200486 CS29

protocol: 2008-003931-19

 

* JANSSEN-CILAG:

“A prospective, observational study of men with premature ejaculation who are treated with Priligy or alternative care”  
protocol: R096769-PRE-4001

 

* Cougar Biotechnology:

“A phase 3, randomized, double-blind, placebo controlled study of Abiraterone acetate (CB7630 plus prednisone in asymptomatic or midly symptomatic patients with metastatic castration-resistant prostate cancer”

protocol: COU-AA-302

 

* GSK:

“An observational study to assess the burden of illness in prostate cancer patients with low to moderate risk of progression”

protocol: AVO112760

 

* Eli Lilly:

“A Randomised, Double-Blind, Placebo-Controlled Studyto Evaluate the Effect on Unassisted Erectile Function of the Early Use of Tadalafil 5 mg Once a Day and Tadalafil 20 mg On Demand Treatment for 9 Months in Subjects Undergoing Bilateral Nerve-Sparing Radical Prostatectomy”

protocol: H6D-EW-LVIK

 

* Bayer:

“A prospective, randomized, double-blind, double-dummy, placebo- and active controlled, multicenter study assessing the efficacy and safety of the combination BAY 60 4552 / vardenafil compared to vardenafil (20 mg) for the treatment of erectile dysfunction not sufficiently responsive to standard therapy with PDE5 inhibitors"

protocol: Bay 98-7081/14694

 

* Ipsen: 

“Prostate Cancer Antigen-3 (PCA-3) and TMPRSS2-ERG (T2-ERG) Score Changes During Initiation of Androgen Deprivation Therapy (ADT) With Triptorelin 22.5mg in Patients With Advanced Prostate Cancer (PCA): A Phase III, Single Arm Multicentre Study” 8-79-52014-168

protocol: 2009-012786-58

 

 

* GSK:

“Comparative efficacy of DUODART plus lifestyle advice versus watchful waiting plus lifestyle advice with step-up therapy to tamsulosin in the management of treatment naïve men with moderately symptomatic benign prostatic hyperplasia and prostate enlargement.”

protocol: FDC 114615 – CONDUCT(studio sottoposto ad audit)

 

* Pierre Fabre Medicament:

"Exploratory study of L.S.E.S.r. (Permixon 160 mg hard capsule) versus tamsulosin LP activity on inflamnation biomarkers in the treatment of urinary symptoms related to benign prostatic hyperplasia"

protocol: P00048 GP 403

 

* NeoTract: 

"A UroLift post market multi centre randomized study"

protocol: BPH-6

 

* Recordati:

"Efficacia di una singola iniezione intraprostatica per via ecografica trans-rettale di polipeptide naturale pro apoptotico nx1207 versus tamsulosina per os. Studio multicentrico randomizzato singolo cieco"

 

* The Medicines Company:

"European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial" (EUROMAX)

 

* The Medicines Company:

"Minimizing adverse haemorrhagic events by transradial access site and systemic implementation of Angiox" (MATRIX)