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A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects with Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer

The purpose of this clinical research study is to compare the effect of panitumumab to cetuximab (Erbitux®) in treating metastatic colorectal cancer in patients whose tumor contains the wild-type (unchanged) KRAS gene and who have previously been…

Efficacy of adjuvant mitotane treatment in prolonging recurrence -free survival in -patients with adrenocortical carcinoma at low-intermediate risk of recurrence

Primary objectiveTo compare the efficacy of adjuvant mitotane treatment vs observational follow-up only in prolonging recurrence free survival (RFS) in patients with ACC after complete resection and low-intermediate risk for disease recurrence.…

A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis (CFTY720D2316)

Primary: Safety and tolerability of fingolimod 0,5 mg in a broader population of MS patients.Explorerend: incidence of macular edema, bradyarrythmia, Patient-Reported Outcomes Indices for Multiple Sclerosis (PRIMuS) and Short Form Health Survey*12 (…

UMPIRE - Use of a Multidrug Pill In Reducing cv Events - a randomised controlled trial of fixed dose combination medication and usual care in those at high risk of cardiovascular disease.

To assess whether provision of the Red Heart polypill (containing low dose aspirin, a statin and two blood pressure lowering medicines) compared to usual cardiovascular medications improves adherence to indicated medicines and clinical outcomes in…

A Phase III randomized, double blind, placebo controlled, multicenter study of panobinostat for maintenance of response in patients with Hodgkinâ¤*s lymphoma who are at risk for relapse after high dose chemotherapy and autologous stem cell transplant

Primary* To compare the disease free survival (DFS) in patients with HL after achieving a complete response following AHSCT with HDT who are treated with panobinostat versus those who receive placebo based on investigator*s review of radiological…

A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis

The primary objective of this Phase 3 extension study will be to obtain essential long term safety data to augment the overall safety database. The secondary objective will be to augment the efficacy information collected in the double-blind study (…

Selective D1 activation by addition of L-Dopa to antipsychotic treatment in patients with schizophrenia

To examine the effect of L-dopa addition to optimal D2-blocking antipsychotic treatment on positive symptoms, negative symptoms, cognitive symptoms and extrapyramidal symptoms in schizophrenia.

A multicentre, prospective, randomized open-label pilot study to assess the feasibility and preliminary efficacy of interferon gamma in combination with Anidulafungin for the treatment of candidemia

To evaluate the preliminary efficacy and feasibility of interferon gamma as adjunctive treatment in combination with the standard regimen, for the treatment of patients with candidemia using the following parametersSecondary objective: to evaluate…

A phase III, randomised, double-blind, placebo-controlled, parallel group, efficacy and safety study of BI 10773 (10 mg and 25 mg administered once daily) as add on to pre-existing antidiabetic therapy over 52 weeks in patients with type 2 diabetes mellitus and renal impairment and insufficient glycaemic control

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 (10 mg and 25 mg/ once daily) compared to placebo given for 52 weeks as add-on preexisting antidiabetic therapy in patients with T2DM with…

A Six Month Phase II/III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Telcagepant (MK-0974) for Prevention of Menstrually Related Migraine in Female Patients with Episodic Migraine

• Test the safety of the research drug, telcagepant (MK-0974)• Test the safety of the research study drug telcagepant (MK-0974) in the prevention of menstrually related migraines. • Compare the effectiveness of the research study drug telcagepant (…

An open, multicentre, randomised, inter-individual comparative, prospective clinical trial with MD-3511356 versus standard sun protection measures in immunosuppressed outpatients after solid organ transplantations for the prevention of UV-induced infections and carcinogenic skin alterations

3. TRIAL OBJECTIVES AND PURPOSE3.1 Primary ObjectiveThe primary objective is the prevention of actinic keratoses and squamous cell carcinomas by local application of MD-3511356 in comparison to standard sun protection measures in immuno-suppressed…

LEADER: Liraglutide Effect and Action in Diabetes Evaluation of cardiovascular outcome Results;A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events.

Primary objective:To assess the effect of treatment with liraglutide compared to placebo for at least 3.5 yearand up to 5 years on the incidence of cardiovascular events, as defined by the belowprimary and secondary endpoints, in adults with type 2…

A Kaletra ONCE daily Randomised Trial of the
pharmacokinetics, safety and efficacy of twice-daily
versus once-daily lopinavir/ritonavir tablets dosed by
weight as part of combination antiretroviral therapy in
HIV-1 infected children (PENTA 18).

Evaluating the current dosing guidelines in children taking the half-strength paediatric tablets will provide reassurance that the recommended lopinavir/ritonavir dose provides adequate drug exposure and maintains efficacy.This trial will evaluate…

A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Elective Hepatic Surgery

The objective of this study is to evaluate the safety and hemostatic effectiveness of FP versus SoCtreatment in controlling parenchymal bleeding during hepatic surgery.

HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease

To determine the safety and efficacy of Dimebon in patients with mild to moderate Huntington Disease

A 24-month, multi-center, open-label, randomized, controlled trial to investigate efficacy, safety and evolution of cardiovascular parameters in de novo renal transplant recipients after early calcineurin inhibitor to everolimus conversion (CRAD001A2429, ELEVATE study)

Primary objective: To demonstrate superior renal allograft function in de novo renal transplant recipients after early CNI to everolimus conversion assessed by Glomerular Filtration Rate (eGFR) estimated by the Modification of Diet in Renal Disease…

Evaluation of the Safety and Efficacy of Short-term A 002 Treatment in Subjects with Acute Coronary Syndromes

The objective of this study is to evaluate the safety and efficacy of A-002 when added to atorvastatin plus standard-of-care in subjects with an ACS. Specifically this study will examine the effect of treatment on morbidity and mortality as defined…

An Open-Label, Flexible-Dose Study of Retigabine Immediate Release (IR) as Adjunctive Therapy to Specified Monotherapy Antiepileptic Treatments in Adults with Partial-Onset Seizures (RGB113905)

Primary: To evaluate the efficacy of retigabine as adjunctive therapy to each of the following specified monotherapy AED treatments: carbamazepine/ oxcarbazepine, lamotrigine, levetiracetam or valproic acid in subjects with partial-onset seizures (…

Durable-Response Therapy Evaluation For Early -or New-Onset Type 1 Diabetes.

Primary objective:* To demonstrate that subjects who receive an 8-day series of Otelixizumab infusions have greater improvement than subjects who receive placebo in endogenous insulin secretion at 12 months after study drug administration. Secondary…

The TEAM trial (Tasigna efficacy in advanced melanoma): A randomized, phase III, open label, multi-center, two-arm study to compare the efficacy of Tasigna® versus dacarbazine (DTIC) in the treatment of patients with metastatic and/or inoperable melanoma harboring a c-Kit mutation

Primary objective:* To compare the clinical efficacy of nilotinib to DTIC, based on progression free survival (PFS), in the treatment of c-Kit mutated melanoma in patients who have not received prior therapy with TKIs.Key secondary objectives:* To…