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Sulodexide for chronic heart failure: a proof of concept, randomized, open-label, placebo-controlled study

To assess the efficacy of treatment with sulodexide for chronic heart failure.

A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

Primary:* To demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment in study participants with primary ITPSecondary:* To assess the safety and tolerability of rozanolixizumabExploratory:* To evaluate the clinical efficacy as…

A randomized, double-blind, placebo-controlled, multiple ascending dose study to examine the safety, tolerability and pharmacokinetics of orally administered PHA-022121 in healthy subjects.

Primary ObjectiveTo assess the tolerability and safety of multiple ascending oral doses of PHA-022121 administered after a standard caloric meal in healthy adult subjects.To assess the PK characteristics of PHA-022121 after administration of…

A randomized, placebo-controlled, double-blind, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of NX210 in healthy volunteers.

Primary objective:To assess the safety and tolerability of single doses of i.v. administered NX210.Secondary objective:To assess the PK of NX210 via its metabolite NX210c in plasma after single doses of i.v. administered NX210.Exploratory objectives…

A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory, Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Combination with Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis

To evaluate the effects of AMT-101 in combination with adalimumab on UC disease activity as measured by symptoms, endoscopy, histology, and biomarkers. To evaluate the safety and tolerability of oral AMT-101 over 8 weeksTo assess the PK parameters…

Individual albuminuria lowering response to dapagliflozin in a decentralized
clinical trial in patients with type 2 diabetes mellitus and elevated albuminuria

Primary: To determine the individual response to the SGTL2 inhibitor dapagliflozin in urine albumin-to-creatinine ratio (UACR) Secondary:- To determine the individual response to the SGLT2 inhibitor dapagliflozin in: - Systolic blood pressure - Body…

A Double-Blind, Vehicle-Controlled, Randomized Withdrawal and Treatment Extension Study to Assess the Long-Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo

Primary Objective:To evaluate the duration of clinical response of ruxolitinib cream in participants with vitiligo.

Dupilumab in adults with severe chronic hand eczema with an inadequate response or intolerance to alitretinoin: a randomized, double-blind, placebo-controlled proof of concept efficacy study

Main study:To evaluate the efficacy of dupilumab in patients with inflammatory subtypes of severe chronic hand eczema with an inadequate response or intolerance to alitretinoin and in patients with concomitant positive patch test results.Substudy:…

Effectiveness of methylphenidate in children and adults with Smith Magenis syndrome and attention-deficit/hyperactivity disorder: An N-of-1 series

The primary objective is to determine the efficacy of methylphenidate on ADHD symptoms in Smith Magenis syndrome.The secondary objectives include the efficacy of methylphenidate on emotion dysregulation and specific goals that are important to the…

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk For or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene

This study has been transitioned to CTIS with ID 2023-506873-36-00 check the CTIS register for the current data. The primary objective of this study is: Part 1: To evaluate the efficacy of AL001 compared with placebo as measured by CDR® plus NACC…

A multi-center, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CK-3773274 in adults with symptomatic hypertrophic cardiomyopathy

Primary objectives:To determine the safety and tolerability of CK-3773274 in patients with symptomatic HCMSecondary objectives:- To describe the concentration-response relationship of CK-3773274 on the resting and post-Valsalva LVOT-G on…

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment (CAHTALYST)

The purpose of this study is to see if Crinecerfont is effective in reducing daily glucocorticoid dosage while maintaining adrenal androgen control.The purpose of the study is also to see if Crinecerfont is effective in reducing adrenal steroid…

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoid Use in Adult Subjects with Classic Congenital Adrenal Hyperplasia

This study has been transitioned to CTIS with ID 2023-503771-13-00 check the CTIS register for the current data. The purpose of this study is to see if tildacerfont can reduce the amount of GC (e.g., hydrocortisone) you need to take and reduce the…

A Phase 1/2 Multiple-Ascending-Dose Study With a Long-Term Open-Label Extension to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effect on Disease Progression of BIIB105 Administered Intrathecally to Adults With Amyotrophic Lateral Sclerosis With or Without PolyCAG Expansion in the ATXN2 Gene

Part 1: The primary objective is to evaluate the safety and tolerability of BIIB105 in participants with amyotrophic lateral sclerosis (ALS) or poly-CAG expansion (polyQ)-ALS.Part 2: The primary objective is to evaluate the long-term safety and…

A randomized, double-blind, placebo-controlled phase III multi-center study of azacitidine with or without MBG453 for the treatment of patients with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

The anti-TIM-3 monoclonal antibody MBG453 is a novel immunotherapeutic agent with promising activity seen in AML and MDS. The purpose of the current study is to assess clinical effects of MBG453 in combination with azacitidine in adult subjects with…

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prophylaxis of Migraine in Participants with Episodic Migraine Who Have Previously Failed 2 to 4 Classes of Oral Prophylactic Treatments (ELEVATE)

To prospectively test for superiority of atogepant 60 mg QD versus placebo for the prevention of migraine in participants with episodic migraine who have previously failed 2 to 4 classes of oral medications for the prophylaxis of migraine

A double-blind, placebo-controlled randomized clinical trial with valsartan for PRevention of Acute rEspiraTORy dIstress syndrome in hospitAlized patieNts with SARS-COV-2 Infection Disease

To investigate the effect of the ARB valsartan in comparison to placebo on the occurrence of one of the following items, within 14 days of randomization:1) ICU admission; 2) Mechanical ventilation; 3) Mortality.

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, Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study)

The primary objectives are:* United States Food and Drug Administration (FDA) primary objectiveTo demonstrate noninferiority in subjects who received an allogeneic BMT for subjects randomized to Rezafungin for Injection compared to subjects…

A single-center, prospective, placebo-controlled, double-blind, randomized, cross-over mechanistic intervention study to investigate the effect of empagliflozin on kidney function in people with either preserved or impaired kidney function with or without type 2 diabetes

We aim to investigate the renal hemodynamic effects of empagliflozin in people with either preserved or impaired renal function with T2DM and people with impaired renal function without T2DM, all with and without adenosine blockade.