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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients with Moderate-to-Severe Plaque Psoriasis

Objectives: The primary objectives of the study are to assess whether 80 mg LY2439821 every 2 weeks (Q2W) or every 4 weeks (Q4W) is:* Superior to placebo at Week 12 in the treatment of patients with moderate-to-severe plaque Ps as measured by: o…

Phase III, multi-center, randomized, 48 weeks, double-blind, parallel-group, placebo-controlled study to evaluate efficacy and safety of CER-001 on vessel wall area in patients with genetically definded familial primary hypoalphalipoproteinemia and receiving background optimized lipid therapy, with optional open-label safety extension

The primary objectives of the study are:• To evaluate the effect of 24 weeks treatment with CER-001 on carotid Mean Vessel Wall Area (MVWA) as compared to placebo using 3T magnetic resonance imaging (3T-MRI);• To evaluate the safety and tolerability…

A Phase 2a, Two-part, Randomized, Double-blind, Placebo-controlled, Incomplete Block Crossover Study to Evaluate the Safety and Efficacy of VX-371 Solution for Inhalation With and Without Oral Ivacaftor in Subjects With Primary Ciliary Dyskinesia

Main objectivePart A: To evaluate the safety and efficacy of treatment with VX-371, administered with and without 4.2% hypertonic saline (HS) in subjects with primary ciliary dyskinesia (PCD) who are *12 years of age.Part B: To evaluate the safety…

Phase shift in adult ADHD of sleep and apetite.

In this study the best treatment of DSPS will be investigated by comparison of existing treatments. We will investigate is patients with ADHD and DSPS have less favorable blood values for biomarkers of chronic diseases in comparison with norm values…

Safety and Efficacy with Twice Daily Brinzolamide 1% / Brimonidine 0.2% (SIMBRINZA) as an Adjunctive Therapy to Travoprost 0.004% / Timolol 0.5% (DUOTRAV)

To demonstrate the additive IOP lowering effect of SIMBRINZA (dosed BID) when added to DUOTRAV solution in subjects with open-angle glaucoma or ocular hypertension.

A 24 weeks multicentre, randomized, double-blind, placebo-controlled, parallel group, study to evaluate the efficacy, safety and tolerability of intravenous IG-8801 20 mg and 40 mg in subjects with chronic low back pain

To assess, in patients with non-specific low back pain, lasting for over 3 months, the effect of two doses of olpadronate administered intravenously on low back pain as compared to placebo treatment. Assessment of safety and tolerability are also…

A Phase 3, Double Blind, Placebo Controlled Trial and Long Term Safety Extension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis

Main Objective: To assess the effects of OCA in patients with PBC on: -Serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint -SafetySecondary Objectives:To assess the effects of OCA in patients with PBC on:-…

A Multi-center, Double-blind, Randomized, Three-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants.

To assess the efficacy and safety of 2 dose levels of NTRA-2112 on intestinal malabsorption in preterm infants as compared to placebo.The sub-study aims to determine whether NTRA-2112 in own mother's milk, donor human milk or preterm formula…

A RaNdomized Double-blInd Placebo ConTrolled Study Characterizing THe Effects of PCSK9 Inhibition On Arterial Wall Inflammation in Patients With Elevated Lp(a) (ANITSCHKOW)

Patients with hyperlipidemie and an elevated Lp(a) will be asked to partipate in this study. This part potentially increases the risk of cardiovascular diseases. One of the reasons why Lp(a) is expected to increases this risk is that Lp(a)…

A Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in Subjects with Narcolepsy with Cataplexy

Primary objective:To evaluate the efficacy of JZP-258 in the treatment of cataplexy in subjects with narcolepsyKey Secondary objective:To evaluate the efficacy of JZP-258 in the treatment of excessive daytime sleepiness (EDS) in…

A Phase 2a Randomized, Double-Blind, Placebo and Active Comparator-Controlled, Parallel Group, Dose-Range Finding Study of MVT-602 in Healthy Premenopausal Women Undergoing Controlled Ovarian Stimulation (COS) Using a Minimal Stimulation Protocol.

To characterize the exposure-response relationship of MVT-602 effects on luteinizing hormone (LH) concentrations after subcutaneous administration of single 0.1 to 3 µg doses of MVT-602 or placebo in healthy premenopausal women undergoing COS to…

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of NPT189 in Healthy Subjects

The purpose of this study is to investigate how safe the new compound NPT189 is when it is administered to healthy subjects. NPT189 has not been administered to humans before. It has been previously tested in the laboratory and on animals. NPT189…

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Subjects with Moderate to Severe Hidradenitis Suppurativa

Primary ObjectiveThe primary objective of this study is to evaluate the initial efficacy, safety, and tolerability of guselkumab in adult participants with moderate to severe hidradenitis suppurativa (HS).Secondary ObjectivesThe secondary objectives…

A Randomized, Double-Blind, Phase III Study of Carboplatin-Paclitaxel/Nab-Paclitaxel;Chemotherapy with or without Pembrolizumab (MK-3475) in First Line Metastatic Squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-407)

Primary:In 1L subjects with metastatic squamous non-small cell lung cancer (NSCLC) receiving investigator*s choice of standard of care chemotherapy (i.e. carboplatin and a taxane):1. Evaluate progression free survival (PFS) per RECIST 1.1 as…

A phase 3, placebo controlled, double-blind, randomized, clinical study to determine efficacy, safety and tolerability of pulsed, inhaled nitric oxide (iNO) versus placebo in symptomatic subjects with pulmonary arterial hypertension (PAH): INOvation-1 (Part 1 and Part 2)

Part 1 -Blinded Treatment Period: Primary Objective:To evaluate the efficacy of inhaled nitric oxide (iNO) on exercise using 6-minute walk distance (6MWD) in subjects with pulmonary arterial hypertension (PAH) currently receiving background PAH…

Cognitive Bias Modification: Exploring the effects of a computer-based cognitive bias training in oncology patients at risk for depression and anxiety symptoms -(OncoCogTrain)

The purpose of our study is to test the effect of a computer-based cognitive behavioral intervention (called Cognitive Bias Modification, CBM) on affective symptoms in oncology patients. Here we are collaborating with the Oncology department of the…

A multiple-dose, subject- and investigator-blinded, placebo-controlled, parallel design study to assess the efficacy, safety, and tolerability of ACZ885 (canakinumab) in patients with pulmonary sarcoidosis

This study is designed as a proof-of-concept to assess if inhibition of IL-1* by canakinumabwill improve lung function in association with attenuation of tissue inflammation in patientswith chronic sarcoidosis, therefore allowing further development…

A Phase II randomized, placebo controlled, double-blind, multi-centre study to assess safety and efficacy of incremental doses of QGC001 in patients with NYHA class II/III chronic heart failure with left ventricular systolic dysfunction

Objectives:Primary: Primary objective of the study is to investigate the safety (blood pressure changes until Day 28 and after discontinuation from Day 28 up to Day 35) and efficacy (rate of decrease in NT-proBNP of more then 30% from baseline to…

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

The primary objective of the study is to evaluate the efficacy of 2 dose regimens of BIIB074 on neuropathic pain in subjects with PLSR.A secondary objective is to evaluate the efficacy of 2 dose regimens of BIIB074 on additional neuropathic pain…

A Randomised, Double-Blind, Placebo-Controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary AlveoLAr Proteinosis Patients

The main purpose of this study is to investigate how molgramostim improves the flow of oxygen from the lungs to the blood in patients with aPAP. The effect on lung function as a whole will also be studied, along with any improvement in the patients…