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A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases

Primary: The primary objective of the Double-blind Acute Phase of the study is to assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate UC.The primary…

A randomized double-blind placebo-controlled study to evaluate the
efficacy and safety of Cinryze® (C1 esterase inhibitor [human]) for the
treatment of acute antibody-mediated rejection in kidney transplant
patients

To evaluate the efficacy of Cinryze administered with plasmapheresis, plasma exchange, or immune adsorption treatments and sucrose-free intravenous immunoglobulin (IVIg) for the treatment of acute antibody-mediated rejection (AMR) of renal allograft…

Phase 3 Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Compare the Efficacy and Safety of Lenalidomide (CC-5013) Plus R-CHOP Chemotherapy (R2-CHOP) Versus Placebo Plus R-CHOP Chemotherapy in Subjects With Previously Untreated Activated B-Cell Type Diffuse Large B-Cell Lymphoma

To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP)…

A Phase III, double-blind, randomized, placebo-controlled multi-centre, study to assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy (ADAURA)

To assess the efficacy of AZD9291 compared to placebo as measured by disease free survival (DFS)Protocol v1.0, 4Jun2015, p30

A Randomised, Double-Blind Study to Assess the Efficacy of Selumetinib
(AZD6244, Hyd-Sulfate) in Combination with Dacarbazine Compared with
Placebo in Combination with Dacarbazine as First Systemic Therapy in
Patients with Metastatic Uveal Melanoma (SUMIT)

ObjectivesPrimary objective1. To assess the efficacy of selumetinib in combination with dacarbazine compared with placebo in combination with dacarbazine in terms of Progression Free Survival (PFS) assessed by blinded independent central review (…

The ORANGE II PLUS - Trial: An international multicentre randomized controlled trial of open versus laparoscopic liver surgery (hemihepatectomy and postero-superior liver segment resection).

Hypotheses: - For patients undergoing a laparoscopic left or right hemihepatectomy (with or without the need for one additional hepatic wedge resection or metastasectomy), time to functional recovery is reduced by 2 days in comparison with patients…

NAI114373: A Phase III international, randomized, doubleblind, double-dummy study to evaluate the efficacy and safety of 300 mg or 600 mg of intravenous zanamivir twice daily compared to 75 mg of oral oseltamivir twice daily in the treatment of hospitalized adults and adolescents with influenza (NAI114373)

Primary: To assess the efficacy of treatment with 300 mg or 600 mg of intravenous (IV) zanamivir twice daily compared to 75 mg of oral oseltamivir twice daily on time to clinical response. Secondary: reduction in viral load from nasopharyngeal swabs…

A Placebo-controlled, Double-blind, Randomised, Parallel-group, Long-term Phase III Trial Assessing the Safety and Efficacy of 50 microgram and 100 mircrogram/day of eprotirome in Patients with Heterozygous Familial Hypercholesterolaemia who are on Optimal Standard of Care

The primary objective of this study is to compare the efficacy of eprotirome 50 microgram and eprotirome 100 micorgram versus placebo in terms of the percent change in LDL-C from baseline to Week 12 in HeFH patients with CAD, or who are at high risk…

Trial consisting of an 8-week double-blind placebo-controlled part to evaluate efficacy, safety, tolerability and pharmacokinetics of prucalopride in paediatric subjects with functional constipation, aged ???6 months to <18 years, followed by a 16-week open-label comparator (PEG) controlled part, to document safety and tolerability up to 24 weeks

The primary objective is to evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged *6 months to <18 years. Secondary objectives include:1. Investigation of the…

A phase III randomised, double-blind, placebo-controlled, parallel group, efficacy and safety study of linagliptin (5 mg), administered orally once daily over 24 weeks in type 2 diabetic patients (age >=70 years) with insufficient glycaemic control (HbA1c >= 7.0) despite metformin and/or sulphonylurea and/or insulin therapy

The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to stable treatment in elderly patients with diabetes mellitus…

The effects of interferon-gamma on sepsis-induced immunoparalysis, a randomised double-blind placebo-controlled pilot (Phase IIIb) study

The primary aim of this pilot-study is to assess safety and the effects on immune function in patients with septic shock of adjunctive therapy with IFN-gamma, in a placebo-controlled manner. The data obtained will allow us to do a powercalculation…

A phase III randomised, double-blind, placebo-controlled, parallel group, efficacy and safety study of BI 10773 (10 mg, 25 mg) administered orally, once daily over 12 weeks in hypertensive patients with type 2 diabetes mellitus

The objective of the current study is to investigate the efficacy and safety of BI 10773 (10 and 25 mg) compared to placebo on glucose control and bloodpressure over 12 weeks in hypertensive patients with diabetes mellitus type 2.

A randomized controlled trial into the efficacy of neurofeedback for treatment of major depressive disorder

In this study, we have the following research objectives:1. To examine if NF, by applying the above mentioned AA-protocol, is an efficacious treatment for major depressive disorder. We will conduct a RCT in which active NF will be compared to sham-…

Laser therapy for onychomycosis in patients with diabetes at risk for diabetic foot complications
A randomized, double blind controlled trial.

To determine the efficacy and safety of laser therapy in diabetes patients with risk factors for developing diabetic foot complications.

A phase III, randomized, placebo-controlled clinical trial to study the efficacy and safety of MK-0517/fosaprepitant and ondansetron versus ondansetron for the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric subjects receiving emetogenic chemotherapy

The objective of the study is to evaluate the efficacy and safety of a single dose of fosaprepitant when administered concomitantly with ondansetron, with or without dexamethasone, in subjects birth to 17 years of age receiving emetogenic…

Monitoring of influenza-like symptoms among elderly, an observational study

Primary Objective: • To determine the incidence rate of self-reported ILI.Secondary Objectives: • To determine the efficacy of 13vPnC in preventing a first episode of self-reported LRTI.• To explore the effect of 13vPnC on the incidence of self-…

A phase 3 randomized, double-blind study of induction (Daunorubicin/Cytarabine) and consolidation (high-dose Cytarabine) chemotherapy + Midostaurin (PKC412) (IND# 101261) or placebo in newly diagnosed patients < 60 years of age with FLT3 mutated Acute Myeloid Leukemia (AML)

To determine if the addition of midostaurin to daunorubicin/ cytarabine induction, high dose cytarabine consolidation, and continuation therapy improves overall survival (OS) in both the mutant FLT3-ITD and FLT-3 TKD AML patients.

The effect of device-guided breathing exercises on blood pressure in diabetic patients with hypertension;A randomized, double-blind controlled trial

Objective: To determine the effect of a device slowing breathing (Resperate©) on office systolic blood pressure (SBP) in diabetic patients with treated hypertension with moderate BP control.

Prospective, randomized, pharmacological intervention study; evaluating the effect of the angiotensin II-receptor (AT1) blocker candesartan versus placebo in prevention of trastuzumab-associated cardiotoxicity in patients with primary breast cancer treated with trastuzumab

Primary objectives:1) To determine whether concurrent ATII-antagonist treatment can prevent trastuzumab-related cardiotoxicity, defined as a decline in LVEF of more than 15% or a decrease to an absolute value &lt;45%Secondary objectives:1) To…

TElmisartan 80 mg plus AMlodipine 10 mg fixed-dose combination tablet STudy versus Amlodipine 10 mg over encapsulated tablets as first line therapy in patients with Type 2 Diabetes Mellitus and Stage 1 or 2 hypertension: a phase III, eight week, randomised, double-blind, double-dummy, forced titration comparison - a ABPM substudy

This study investigates whether the fixed-dose combination of telmsartan 80 plus amlodipine 5 or 10 is superior as a first line treatment to amlodipine 5 or 10 mg monotherapy of lowering mean sitting systolisch blood pressure in patients with…