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A phase III, Randomized Trial of Surgical Resection With or Without BCG versus Best Medical Therapy as Initial Treatment in Stage IV Melanoma

This study will establish the role of surgical versus nonsurgical approaches in patients whose melanoma has spread to distant sites. Results will help clinicians develop a standardized initial approach that prolongs survival and optimizes quality of…

A Phase 3, Randomized, Double-blind Study of Siltuximab (Anti-IL-6 Monoclonal Antibody) or Placebo in Combination With VELCADE and Dexamethasone for the Treatment of Subjects With Relapsed or Refractory Multiple Myeloma

The primary objective of this study is to determine if there is an improvement in progression-free survival(PFS) when siltuximab is added to VELCADE* (bortezomib) and dexamethasone in subjects with relapsedor refractory multiple myeloma.The…

Multi-electrode PulmonarY Vein isolation vs Single Tip wide area Catheter ablation for Paroxysmal Atrial Fibrillation

Purpose is to show that multi-electrode ablation is not inferior to irrigated single tip catheter ablation guided by 3-D mapping to treat paroxysmal atrial fibrillation.

An Efficacy and 2-Year Safety Study of Open-label Rosuvastatin in Children and Adolescents (aged from 6 to less than 18 years) with Familial Hypercholesterolaemia

Primary Objectives * To assess the efficacy of rosuvastatin in paediatric patients with familial hypercholesterolaemia. * To establish long-term safety, tolerability and efficacy of rosuvastatin in paediatric patients with familial…

Bilateral cochlear implantation in children; a pragmatic randomised controlled trial

To evaluate the effectiveness of bilateral implantation over unilateral implantation in children with severe-to-profound sensorineural hearing loss. Furthermore with this study we will investigate whether simultaneous bilateral implantation is…

A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study of the Pharmacokinetics of OMS302 and the Effect of OMS302 on Intraoperative Pupil Diameter and Early Postoperative Pain in Subjects Undergoing Intra Ocular Lens Replacement with Phacoemulsification.

The co-primary objectives of this study are to evaluate the effect of OMS302 compared to placebo when administered in irrigation solution during phacoemulsification and intraocular lens replacement on: • Intraoperative pupil diameter.• Pain during…

A randomized double blind, placebo-controlled study of fluoxetine in progressive multiple sclerosis (FLUOX-PMS)

We expect that in people with multiple sclerosis the processing of energy substances such as sugars (energy metabolism)i n the brains is not optimal . In our view this could explain the progressive deterioration of the disease. Currently there are…

NGR015: Randomised double-blind phase III study of NGR-hTNF plus best investigator's choice (BIC) versus placebo plus BIC in previously treated patients with advanced malignant pleural mesothelioma (MPM)

Primary:• To compare overall survival (OS) in patientsrandomized to NGR-hTNF plus BIC versuspatients randomized to placebo plus BICSecondary:• To compare progression-free survival (PFS)• To compare disease control rate (DCR, defined asthe percentage…

A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg vs
at 10 mg/kg in Subjects with Previously Treated or Untreated Unresectable or Metastatic
Melanoma

To compare the overall survival of ipilimumab monotherapy at doses of 3 mg/kg versus 10 mg/kg in subjects with previously treated or untreated unresectable Stage III or Stage IV melanoma

A Phase 3 Study with Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects with Chronic Hepatitis C Genotype 1b Infection.;+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 13-Mar-12)

Primary Objective:This research study is designed to assess the effectiveness of the combination of study drugs (ASV + DCV) being used to treat the hepatitis C virus (HCV). The best way to assess this aim is to measure the amount of virus in…

Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST 261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment

Ulcerative colitis is an inflammatory disease that affects the colon. The extent and severity of the disease may vary: it is possible that the disease only the rectum (the lower part of the colon) found, but the disease may extend over the entire…

A 24-month, phase IIIb, open-label, randomized, active-controlled,
3-arm, multicenter study assessing the efficacy and safety of an individualized,
stabilization-criteria-driven pro re nata (PRN) dosing regimen with 0.5-mg
ranibizumab intravitreal injections applied as monotherapy or with adjunctive laser
photocoagulation in comparison to laser photocoagulation in patients with visual
impairment due to macular edema secondary to branch retinal vein occlusion
(BRVO)

Primary objective:To demonstrate that an individualized stabilization-criteria-driven PRN dosingregimen (PRN) with 0.5-mg ranibizumab administered with or without adjunctive lasertreatment has superior efficacy as compared to the current standard of…

A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects with Overactive Bladder (OAB) Treated with Antimuscarinics and Dissatisfied due to Lack of Efficacy

To assess the efficacy of Mirabegron 50mg versus Solifenacin 5mg in the treatment of subjects with OAB who were dissatisfied with their treatment due to lack of efficacy.

An Open-Label, Long-Term Extension, Multi-center, Sequential Dose Titration Study to Assess Safety and Efficacy of Solifenacin Succinate Suspension in Pediatric Subjects with Overactive Bladder (OAB)

To evaluate the safety and efficacy of solifenacin succinate suspension once daily in children and adolescents with OAB.

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura).

Core Study:Primary objective: • To demonstrate that the efficacy of E5501 (in addition to standard of care) is superior to placebo (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic…

A randomized controlled trial to asses the effect of vitamin D in patients with atopic dermatitis.

The main study objective is to determine the time to, as well as number of exacerbations of atopic dermatitis in the study period between the study groups A and B. The secondary objectives are the differences in transepidermal water loss and Quality…

An Open-label Randomized Phase III Trial of BMS-936558 versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)

Primary ObjectiveTo compare the objective response rate and overall surival of BMS-936558 versus docetaxel in subjects with squamous cell NSCLC after failure of prior platinum-based chemotherapySecondary ObjectivesTo compare the progression-free…

A study to compare the efficacy and safety of once daily QVA149 vs. the once daily concurrent administration of QAB149 plus NVA237 in patients with moderate to severe chronic obstructive pulmonary disease (CQVA149A2326)

Primary objective: To evaluate the non-inferiority of QVA149 110/50 µg qd as compared to concurrentadministration of QAB149 150 µg qd plus NVA237 50 µg qd in terms of its effect on trough FEV1 (mean of 23 h 15 min and 23 h 45 min post-dose)…

A PROSPECTIVE, MULTINATIONAL, OPEN-LABEL, SINGLE-ARM, EXPLORATIVE STUDY TO EVALUATE THE TOLERABILITY AND EFFICACY OF LACOSAMIDE WHEN ADDED TO LEVETIRACETAM WITH WITHDRAWAL OF THE CONCOMITANT SODIUM CHANNEL BLOCKING ANTIEPILEPTIC DRUG IN SUBJECTS WITH UNCONTROLLED PARTIAL-ONSET SEIZURES

The primary objective of this study is to assess the overall effectiveness of LCM (optimizedwithin the range of 200mg/day to 600mg/day) when added to a stable dose of LEV (in thelabel range of 1000mg/day to 3000mg/day) with withdrawal of the…

A randomized, double-blind, multicenter, Phase III study of everolimus (RAD001) plus best supportive care versus placebo plus best supportive care in the treatment of patients with advanced NET of GI or lung origin -

To determine whether treatment with everolimus 10 mg daily plus best supportive care prolongs PFS compared with placebo plus best supportive care in patients with advanced NET of GI or lung origin without a history of carcinoid symptoms