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*The MEtformin-LIfestyle in Antipsychotic users trial (MELIA): optimizing the use of metformin in the management of antipsychotic-induced weight gain.*

Objective: We aim to optimize the application of an existing drug, metformin, for a new indication, AiWG, by showing that metformin in combination with lifestyle interventions reduces AiWG compared to placebo in combination with lifestyle…

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects with Prurigo Nodularis

The primary objective is to assess the efficacy of nemolizumab (CD14152) compared to placebo in subjects >= 18 years of age with prurigo nodularis (PN) after a 16-week treatment period.

CV019-010: A Randomized, Double-Blinded, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of BMS-986259 in Stabilized Patients Hospitalized for Acute Decompensated Heart Failure

The purpose of this study is to evaluate the effectiveness of the BMS-986259 study drug on blood pressure events in stable participants diagnosed with heart failure admitted to the hospital with Acute Decompensated Heart Failure (ADHF).

A PHASE 3, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, STUDY OF THE EFFICACY AND SAFETY OF LANREOTIDE AUTOGEL/ DEPOT 120 MG PLUS BSC VS. PLACEBO PLUS BSC FOR TUMOR CONTROL IN SUBJECTS WITH WELL DIFFERENTIATED, METASTATIC AND/OR UNRESECTABLE TYPICAL OR ATYPICAL LUNG NEUROENDOCRINE TUMORS

Primary Objective* To describe the antitumour efficacy of LAN monotherapy plus BSC every 28 days, in terms of progression-free survival (PFS), measured by central review using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria,…

The effect of a single gift antibiotics before ERCP to prevent post-ERCP pancreatitis.
A study protocol for a single centre, double blinded randomized controlled study.

This study aims to further reduce the incidence of a post-ERCP pancreatitis by administrating a single gift antibiotics after the procedure.

A Randomized, Double Blind, Placebo Controlled, Phase 2a Study to Assess the Clinical Efficacy of ISIS 721744, a Second Generation Ligand Conjugated Antisense Inhibitor of Prekallikrein, in Patients with Hereditary Angioedema

The primary objective of the study is to evaluate the clinical efficacy of antisense inhibitor of prekallikrein (ISIS 721744) in patients with hereditary angioedema (HAE) type 1 (HAE 1), HAE type 2 (HAE 2), or HAE with normal C1-inhibitor (C1-INH).…

BACILLUS CALMETTE-GUÉRIN VACCINATION TO PREVENT SERIOUS RESPIRATORY TRACT INFECTION AND COVID-19 IN VULNERABLE ELDERLY -* AN ADAPTIVE RANDOMIZED CONTROLLED TRIAL

To determine the impact of BCG vaccination on the incidence of clinically relevant respiratory infections or COVID-19 in vulnerablel older adults.

A randomized, double-blind, placebo-controlled single and multiple ascending dose study to test the safety, tolerability, pharmacokinetics and pharmacodynamics of NT-0167 in healthy volunteers

Primary:- To evaluate the safety and tolerability of NT-0167 in healthy volunteersSecondary:- To evaluate the pharmacokinetic (PK) profile of NT-0167 in healthy volunteers after the administration of single ascending (SAD) and multiple ascending…

A Multicenter, Randomized, Placebo-Controlled, Double-Blind Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAR443060 in Subjects with Amyotrophic Lateral Sclerosis (ALS)

Double-blinded part:The primary objectives of the study are as follows:• To investigate the safety and tolerability of 28 days of oral doses of SAR443060 in subjects with ALS.The secondary objectives of the study are as follows: • To characterize…

A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (study 209229)

Primary: • Compare the efficacy of GSK3359609 in combination with pembrolizumab to pembrolizumab plus placebo in the PD-L1 expression positive (CPS >=1) population and in the PD-L1 expression high (CPS>=20) populationSecondary: •…

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease

The scientific rationale for the study is summarized above and further detailed in Section 3 and the Investigator Brochure (IB). This Phase 2 randomized, double-blind clinical trial is designed to assess the safety and efficacy of BMS-986165 in…

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease

MAIN Trial:Primary:To evaluate whether the efficacy of mirikizumab is superior to placebo in participants with Crohn's disease as assessed by- clinical response by patient reported outcome (PRO) at Week 12 andendoscopic response at Week 52-…

A First-in-Human, Randomized, Double-Blinded, Placebo-Controlled Trial in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Intravenous Dose Levels of ARGX-117 and Subcutaneous Dose Levels of ARGX-117 Co-Mixed with Recombinant Human Hyaluronidase PH20

This is the first clinical study in which ARGX 117 is administered to humans. The purpose of this study is to investigate how safe the new compound ARGX-117 is and how well it is tolerated when it is administered to healthy volunteers. It will also…

The effect of targeted nutrient supplementation on physical activity and health related quality of life in COPD

To investigate the efficacy of targeted nutrient supplementation on daily physical activity level as well as generic health status in patients with moderate to very severe COPD. Additionally, we aim to disentangle the relative effect of targeted…

A phase 3, multicenter, double-blind, randomized, placebo-controlled study of ivosidenib or enasidenib in combination with induction therapy and consolidation therapy followed by maintenance therapy in patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome with excess blasts-2, with an IDH1 or IDH2 mutation, respectively, eligible for intensive chemotherapy.

This study has been transitioned to CTIS with ID 2022-502832-37-00 check the CTIS register for the current data. To assess efficacy and safety of ivosidenib/enasidenib vs. placebo in combination with induction therapy and consolidation therapy…

A Phase II, randomized, multi-center, placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud*s phenomenon (RP) and peripheral vascular blood flow, in subjects with systemic sclerosis (SSc)

Primary:To determine the safety and efficacy of GS-248 versus placebo on RP in subjects with SSc.Secondary:To determine the efficacy of GS-248 on peripheral vascular blood flow in subjects with SSc and RP.Exploratory:• To explore the…

HELIOS-B: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy)

This study has been transitioned to CTIS with ID 2024-518318-25-00 check the CTIS register for the current data. Primary: • To evaluate the efficacy of vutrisiran compared to placebo on reducing all-cause mortality and cardiovascular (CV)-related…

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD)

Primary:• To compare the efficacy of viltolarsen administered intravenously (IV) at weekly doses of 80 mg/kg over a 48-week treatment period vs. placebo controls in ambulant boys ages 4 to <8 years with DMD using the Time to Stand Test (…

Deferoxamine in Aneurysmal Subarachnoid Hemorrhage trial

This study has been transitioned to CTIS with ID 2024-514615-10-01 check the CTIS register for the current data. This study investigates the effectivity and the safety of deferoxamine use in patients with aneurysma subarachnoidhemorrhage.

A Randomized, Placebo-Controlled, Double-blind, Multiple Dose, Phase 1 Study to Evaluate the
Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of SRK-001 in
Healthy Participants.

In this study, SRK-001 is being investigated to see how safe it is and how well it is tolerated when it is administered to healthy participants.We will also investigate how quickly and to what extent SRK-001 is absorbed, distributed, and eliminated…