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A Phase 1b, Randomized, Double-Blind (Sponsor Open), Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PF-04447943, Co-Administered with and Without Hydroxyurea, in Subjects with Stable Sickle Cell Disease

Primary ObjectiveTo determine the safety and tolerability of multipledoses of PF-04447943 Secondary ObjectiveTo characterize the PK of PF-04447943 in plasma following oral administrationExploratory ObjectivesTo evaluate biomarkers that may be…

Human intestinal ischemia and reperfusion

This study aims at (further) revealing the pathophysiology of intestinal IR in man, with a specific interest for the role of proteases and protease-activated receptor-2 (PAR-2), cellular and inflammatory changes, barrier function and intestinal…

Double-blinded, randomised, placebo-controlled, multicentre , Phase IIa study to investigate the effect, safety and tolerability of phosphorylcholine human monoclonal antibody (PC-mAb) 3G10 on arterial inflammation, together with safety and tolerability, in subjects with elevated lipoprotein a (Lp[a ])

1. The primary objective is to assess the effects of four 250 mg PC-mAB (also referred to as "3G10") once monthly intravenous injections on monocyte function ex vivo. The secondary objectives are to:1. assess the functional effects of 3G10…

The LIPMAT study: Liposomal prednisolone to improve hemodialysis fistula maturation

To demonstrate whether liposomal prednisolone is effective in promoting AVF maturation after surgical creation of a radiocephalic AVF.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled,
Parallel Group Study to Evaluate the Efficacy and Safety of
Sirukumab in the Treatment of Patients with Giant Cell Arteritis

Part A: 52-week double-blind treatment phasePrimary* To investigate the efficacy of sirukumab (100 mg q2w for 12 months) as compared to placebo, each administered in addition to a 6-month prednisone treatment regimen Secondary* To assess cumulative…

Phase 2a, Double-Blind, Placebo-Controlled, 2-Period, 2-Treatment, Crossover Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Oral Doses of XPF-001 (400 mg bid) in Patients with Inherited Erythromelalgia

• To evaluate the safety and efficacy of multiple doses of XPF-001 (400 mg bid) for relief of pain in patients with IEM.• To evaluate the efficacy of multiple doses of XPF-001 (400 mg bid) for relief of vasomotor signs in patient with IEM.• To…

Silencing Inflammatory activity by injecting Nanocort in patients at risk for atherosclerotic disease

This study is designed to evaluate the effects of short-term liposomal glucocorticoid (Nanocort) infusion on atherosclerotic plaque inflammation in humans measured by 18FDG PET/CT

Treatment of Ectopic Mineralization in Pseudoxanthoma Elasticum.

The main objective is to determine if bisphosphonate therapy with etidronate leads to stabilization or attenuation of ongoing calcification in the leg arteries as quantified by 18F-sodium fluoride(18F-NaF) PET-CT imaging in patients with PXE.…

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis on Background Cyclophosphamide or Rituximab Treatment

This study is set-up to evaluate the safety and tolerability of CCX168 in subjects with mild to moderate AARV on a background of cyclophosphamide treatment. It will assess the possibility to optimize the treatment with CCX168 and to reduce the side…

The effect of dietary nitrate (beetroot juice) on the microcirculation in healthy adults; A pilot study

The primary objective is to determine the effects of dietary nitrate (beet root juice) on the microcirculatory profile in healthy adults. The secondary objectives are 1) to determine the effects of dietary nitrate on macrocirculatory parameters, 2)…

Vitamin c to Improve Tissue healing by Administration of Multiple INtravenous dosages

PrimaryImproved woundhealing in 30 days in patients with an open revascularisation of the lower extremities after treatment with 4 dosages of 2 grams ascorbic acid on 4 consecutive days. (First dosage 1 hour preoperative)SecondaryWith preoperative…

The effects of oligomeric procyanidins (OPCs) on vascular function, biomarkers of oxidative stress and inflammation in smokers: a pilot study

To evaluate the potential attenuating effects of an eight-week supplementation with 200 mg OPCs per day on macro- and microvascular function as well as on systemic biomarkers of inflammation and oxidative stress in healthy smoking subjects.

Postprandial insulin release and the impact on muscle perfusion

We hypothesize, that during an oral glucose tolerance test, the OPS arterial flow measured sublingual will be comparable within the same subject, but different between young, elderly and type 2 diabetic patients. Objective is to quantify differences…

A pilot study examining the effect of abatacept in ANCA associated vasculitis (AAV)

Main objective:To assess the relapse rate (defined by clinical and biochemical parameters) over 24 months in patients with acute AAV presenting at first diagnosis of relapse, after 12 months of treatment with abatacept in combination with steroids…

The effect of hesperidin administration on endothelial function and gut barrier function

To determine the chronic and acute effects of daily administration of hesperidin on cardiovascular and intestinal health as assessed by investigation of endothelial function, blood pressure, heart rate, glucose/insulin metabolism, lipid metabolism…

A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis

Primary:The primary objective of the study is to evaluate the efficacy of KPL-301 versus placebo, coadministeredwith a 26 week steroid taper, for maintaining sustained remission for 26 weeks in subjects with newonsetor relapsing/refractory giant…

The Efficacy and Safety of Intra-Arterial Administration of REX-001 to treat ischaemic rest pain in Subjects with Critical Limb Ischaemia Rutherford Category 4 and Diabetes Mellitus: A Pivotal, Placebo Controlled, Double-Blind, Parallel-Group, Adaptive Trial

To confirm the efficacy and safety of a single intra-arterial administration of REX-001 to relief ischaemic rest pain in subjects with critical limb ischaemia (CLI) Rutherford Category 4 and diabetes mellitus (DM).

A Multi-Center, Prospective, Randomized, Double-Blind,
Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of AMR101
on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients
with Cardiovascular Disease or at High Risk for Cardiovascular Disease:
REDUCE-IT (Reduction of Cardiovascular Events with EPA * Intervention Trial)

The primary objective is, in patients at low-density lipoprotein cholesterol (LDL-C) goal while on statin therapy, with established cardiovascular disease (CVD) or at high risk for CVD, and hypertriglyceridemia (fasting triglycerides [TG] *200 mg/dL…

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Doses and Dose Regimens of Evinacumab in Patients with Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying Therapy

The primary objective of the study is to evaluate the reduction of low density lipoprotein cholesterol (LDL-C) by evinacumab in comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (heterozygous familial…

Randomized, double blind, mutlicenter, multinational, placebo controlled, single parallel escalating dose safety and efficacy study of ACT017 used as an add-on therapy on top of standard of care of acute ischemic stroke

The study primary objective will consist of assessing the safety and tolerability of single IV (bolus + infusion) doses of glenzocimab in patients with an acute ischemic stroke administered on top of the best emergency standard of care (including…