Kusajili – Centralise les essais cliniques mondiaux

Chimeric anti-CD20 monoclonal antibody (Mabthera) in remission induction and maintenance treatment of relapsed follicular non-Hodgkin's lymphoma (NHL): a phase III randomised clinical trial (Intergroup Collaborative Study) Not provided at time of registration

• Pays Australia, Belgium, Canada, Denmark, Egypt, France, Hungary, Italy, Netherlands, New Zealand, Norway, Poland, Slovakia, Slovenia, South Africa, Sweden, Switzerland, United Kingdom,
• Organes Aucun
• Spécialités Aucun

A Study of Tasisulam Versus Paclitaxel as Treatment for Metastatic Melanoma The primary purpose of this study is to see how tasisulam affects metastatic melanoma when compared against paclitaxel as measured by overall survival.

• Pays Australia, Austria, Belgium, Canada, Finland, France, Germany, Israel, Italy, Korea, Republic of, Netherlands, Norway, Poland, Spain, Sweden, Taiwan, Province of China, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun

Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.

• Pays Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Romania, Russian Federation, Serbia, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun

Comparison of Pregabalin Versus Venlafaxine XR and Placebo in the Treatment of Generalized Anxiety Disorder The purpose of the study is to compare pregabalin to Venlafaxine XR and placebo in the treatment of generalized anxiety disorder.

• Pays Belgium, Canada, France, Ireland, Italy, Netherlands, Spain, Sweden,
• Organes Aucun
• Spécialités Aucun

Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients The primary objective is to evaluate the safety and efficacy of eculizumab in transfusion dependent patients with hemolytic PNH.

• Pays Australia, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, Sweden, Switzerland, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun

Predictive Markers in GHD and TS Children Treated With SAIZEN® The study aims at identifying the predictive markers after one month of Saizen therapy in Growth Hormone Deficiency (GHD) and Turner Syndrome children. The study will recruit approximately 360 children in several countries worldwide. The study lasts for about the first one month of daily growth hormone treatment. There will be three clinic visits during the month of the study. There is an initial visit, then a visit before growth hormone treatment starts and finally a visit at the fourth week of treatment. The study requires two additional blood tests to a regular Saizen treatment follow-up. One sample is taken before growth hormone injections start and one additional blood sample is taken at the fourth week of treatment.

• Pays Argentina, Australia, Austria, Canada, France, Germany, Italy, Norway, Russian Federation, Singapore, Spain, Sweden, United Kingdom,
• Organes Aucun
• Spécialités Aucun

Placebo Controlled Double-blind Dose Ranging Study of the Efficacy and Safety of SSR149744C 50, 100, 200 or 300 mg OD With Amiodarone as Calibrator for the Maintenance of Sinus Rhythm in Patients With Recent Atrial Fibrillation/Flutter Double blind study to evaluate the efficacy and tolerability of SSR149744C and select a dose to be further investigated in the maintenance of sinus rhythm after electrical, pharmacological or spontaneous conversion of AF/AFL.

• Pays Argentina, Australia, Canada, Chile, Denmark, France, Germany, Hungary, Italy, Japan, Netherlands, Poland, Russian Federation, Spain, Sweden, Switzerland, United States,
• Organes Aucun
• Spécialités Aucun

nEw3 Post-approval Study The primary purpose of this study is to assess the long term reliability of the Medtronic Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of approval of nEw3 devices. Patients will be followed for 5 years after implant. This study utilizes data collected from the System Longevity Study (SLS).

• Pays Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Serbia, Sweden, Switzerland, United States,
• Organes Aucun
• Spécialités Aucun

Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.

• Pays Austria, Belgium, Canada, Finland, France, Germany, Greece, Italy, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States,
• Organes Aucun
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A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients PRIMARY: To evaluate the efficacy of valacyclovir hydrochloride (BW 256U87) in the prevention of cytomegalovirus (CMV) end-organ disease in HIV/CMV co-infected patients with CD4+ lymphocytes < 100 cells/mm3. To assess the impact of BW 256U87, high-dose oral acyclovir and low-dose oral acyclovir on survival. SECONDARY: To evaluate the effect of BW 256U87 on quality of life, the safety of the drug administered concurrently with standard antiretroviral agents and other essential therapies for the treatment and prevention of opportunistic diseases, and the efficacy of BW 256U87 in suppressing activation of other herpesviruses. To evaluate serologic and virologic risk factors for the development of CMV disease, including assessment of HIV activation, and the risk of developing drug-resistant CMV, HSV, and VZV. Gastrointestinal absorption of acyclovir is not high enough to prevent CMV disease in patients with advanced HIV disease, although there is evidence that high doses of the drug may extend survival. Valacyclovir, a prodrug that is rapidly converted to acyclovir after oral administration, has a higher absorption rate and may therefore provide inhibitory activity against CMV.

• Pays Australia, Canada, Denmark, France, Germany, Italy, Sweden, Switzerland, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun