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A double-blind, randomised, placebo controlled Phase III study of
nintedanib plus best supportive care (BSC) versus placebo plus BSC in
patients with colorectal cancer refractory to standard therapies.

The objective of this Phase III study is to evaluate the efficacy and safety of nintedanib in patients with mCRC after failure of previous treatment with standard chemotherapy and biological agents.

A randomized, double-blind, placebo-controlled study to demonstrate the efficacy and long-term safety of dupilumab in adult patients with moderate-to-severe atopic dermatitis.

Primary objective:To demonstrate the efficacy of dupilumab administered concomitantly with TCS through week 16 in adult patients with moderate-to-severe atopic dermatitis (AD).Secondary objectives:Evaluate long-term efficacy of dupilumab when…

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

• The primary objective of this study is to establish the efficacy of fostamatinib as compared with placebo in achieving a stable platelet response in subjects with persistent/chronic ITP.• Secondary objectives include assessment of the incidence of…

A PHASE 3 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF AMG0001 IN SUBJECTS WITH CRITICAL LIMB ISCHEMIA

The primary objectives of the clinical trial are:1. To estimate the treatment benefit (AMG0001 compared to placebo), in terms of a combined endpoint (major amputations or all-cause death)2. To evaluate the overall safety and efficacy of AMG0001.

A Phase III case series clinical study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5.0g idarucizumab (BI 655075) in patients treated wtih dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.

to investigate the safety and efficacy of idarucizumab in reversing the anticoagulation effect of dabigatran, in patients who have uncontrolled bleeding or require emergency surgery or invasive procedures.

PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS

The primary objective of this endpoint study is to evaluate the safety of tofacitinib at two doses versus TNFi; the co-primary endpoints are adjudicated major adverse cardiovascular events (MACE) and adjudicated malignancies excluding non-melanoma…

Effect of pre-operative pain treatment by means of duloxetine on postoperative outcome after total hip or knee arthroplasty

Primary:To determine the degree pain relief 6 months after THA/TKA when screened pre-operative for centralized pain and subsequent treated accordingly for a period of 10 weeks with Duloxetine compared to usual care (no Duloxetine) Secondary:To…

Reduced-dosed rivaroxaban and standard-dosed rivaroxaban versus ASA in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis and/or pulmonary embolism
The Einstein Choice Study

1. The primary efficacy objective is to evaluate whether rivaroxaban, in doses of 10 mg or 20 mg, is superior to ASA 100 mg in the prevention of the primary efficacy outcome (i.e. fatal or non-fatal symptomatic recurrent venous thromboembolism).2.…

Effect of folic acid supplementation in pregnancy on preeclampsia - Folic Acid Clinical
Trial (FACT)

Primary ObjectiveThe overall aim is to evaluate a new preeclampsia (PE) prevention strategy: 4.0mg (1.0mg x 4) of folic acid supplementation vs. placebo from early (80/7 to 166/7 weeks of gestation) pregnancy until delivery.Secondary ObjectivesTo…

A randomized, placebo, controlled clinical trial to evaluate cardiovascular outcomes after treatment with Exenatide Once Weekly in patients with type 2 diabetes mellitus

The primary objective of EXSCEL will be to evaluate the effect of Bydueron, used in addition to the current usual care for glycemic control, on major macrovascular events when administered to patients with type 2 diabetes.

Interpersonal Community Psychiatric Treatment: cluster randomized trial into cost effectiveness of a structured outpatient treatment for patients with non-psychotic psychiatric disorders in long-term care

This study aims for health gain and cost reduction in the care for people with long-term psychiatric disorders. The researchquestions is what the (cost)effectiveness is of Interpersonal Community Psychiatric Treatment (ICPT), compared to care…

A Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Circadin® To Alleviate Sleep Disturbances in Children with Neurodevelopment Disabilities.

To compare the treatment effect of Circadin 2/5 mg to that of placebo on sleep maintenance (TST) as assessed by the Sleep and Nap Diary after 13 weeks of double-blind treatment.

TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC trial): a randomized controlled trial

To investigate the effectiveness of imiquimod 5% cream for the treatment of CIN2-3 lesions, compared to LLETZ treatment and to assess long-term disease recurrence, side effects and quality of life associated with different treatment modalities.

A phase 3 prospective, multicenter study to evaluate efficacy and safety of rVWF with or without ADVATE in elective surgical procedures in subjects with severe von Willebrand disease

The primary objective of this study is to assess the hemostatic efficacy and safety of rVWF with or without ADVATE in subjects (* 18 years) diagnosed with hereditary severe VWD undergoing major and minor elective surgical procedures.

A multicenter study to evaluate safety and tolerability in patients with chronic heart failure and reduced ejection fraction from PARADIGM-HF receiving open label LCZ696

The primary objective of this study is to continue to evaluate the safety and tolerability of LCZ696 in heart failure patients from PARADIGM-HF receiving open-label investigational drug.There are no secondary objectives for this study.

BOTOX® in the Treatment of Urinary Incontinence Due to Overactive Bladder in Patients 12 to 17 Years of Age

To evaluate the safety and efficacy of BOTOX for the treatment of urinary incontinencedue to overactive bladder (OAB) in patients 12 to 17 years of age who have not been adequately managed with anticholinergic therapy. To evaluate the safety and…

A PHASE III RANDOMIZED TRIAL OF GEMCITABINE PLUS DOCETAXEL FOLLOWED BY DOXORUBICIN V. OBSERVATION FOR UTERUS-LIMITED, HIGH GRADE UTERINE LEIOMYOSARCOMA

To improve overall survival of patients with a early-stage high grade uterine leiomyosarcoma.

A 26- week Extension study of the safety and clinical effects of EVP-6124 in subjects with Alzheimer's disease currently or previously receiving an acetylcholinesterase inhibitor medication

Primary ObjectivesTo assess the safety of 2 fixed doses of EVP-6124 (2 or 3 mg daily) for up to 52 weeks in subjects withAlzheimer*s disease (AD) who complete (Day 182) studies EVP-6124-024 or EVP-6124-025Secondary ObjectivesTo assess the duration…

*In house* Pre-implantation Oxygenated Hypothermic Machine Perfusion Reconditioning after Cold Storage versus Cold Storage alone in ECD Kidneys from Brain Dead Donors

Objective of this study is to compare 1-year garft survival after hypothemic machine perfusion with oxygentaed perfusion solution versus static cold storage of extended criteria kidneys from DBD donors.

The effect of L-arginine on brown adipose tissue metabolism in South Asian and white Caucasian subjects

In this study, we will investigate the influence of the amino acid L-arginine, which enhances release of nitric oxide in the body, on BAT activity and metabolism in healthy subjects with overweight. This will increase understanding on the effect of…