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CONNECTION: A Global Phase 3, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Oral Dimebon in Patients with Mild-to-Moderate Alzheimer's Disease

To determine the benefit of Dimebon as compared to placebo on the primary measure of cognition and memory, the Alzheimer*s Disease Assessment Scale * cognitive subscale (ADAS-cog); andTo determine the benefit of Dimebon as compared to placebo on the…

Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis

To compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight plus budesonide (9mg/d) vs. ursodeoxycholic acid (12-16 mg/kg BW/d) plus placebo in the treatment of PBC. To study safety and…

A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects with a Recent Acute Coronary Syndrome

The primary objective of the study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular (CV) death, myocardial infarction (MI), or stroke in subjects with a recent ACS compared with…

Reduction of Bone Morbidity using Oral Bisphosphonate in Fibrous Dysplasia of Bone

To evaluate the effect of the bisphosphonate risedronate (together with vitamin D and calcium or vitamin D calicum and phosphate in patients with renal phosphate wasting) on bone pain and the evolution of osteolytic bone lesions in patients with FD.

Nasal Intermittent Positive Pressure Ventilation for Premature Infants

Does the use of NIPPV in ELBW infants (<30 wks of GA and BW<1000gr) requiring non-intubated respiratory support in a Level III perinatal center increase the rate of survival without BPD when compared to nCPAP.

A Phase 3, Multi-center, Open-label Continuation
Study in Moderate to Severe Chronic Plaque
Psoriasis Subjects who Completed a Preceding
Psoriasis Study With ABT-874

To assess the long-term safety, tolerability and efficacy of ABT-874 in adults who have either completed or have demonstrated a loss of response (as defined in the original ABT-874 protocol) to treatment in a preceding ABT-874 study in the treatment…

A phase III randomized study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to Imatinib mesylate.

The primary objective of this study is to evaluate whether surgery of residual disease in patients iwth advanced GIST responding to Imatinib improves the progression free survival.The secondary objective is to correlate the pharmacokinetics of…

A Prospective, Multi-Center, Single Arm Study of the Conor Cobalt Chromium Reservoir Based Stent (Nevo) with Sirolimus Elution in Native Coronary Artery Lesions (CP-07 protocol)

The primary objective of this study is to evaluate the target lesion failure rate of the Conor Sirolimus-eluting Coronary Stent System in lesions up to 28 mm in length in native coronary arteries with a reference vessel diameter of 2.5 mm to 3.5 mm…

*Pain exposure* physical therapy versus standard therapy for patients with complex regional pain syndrome type 1 (CRPS-1)

Despite a lacking scientific argumentation, the PEPT approach or Macedonian therapy, is now being adopted on a large scale among physical therapists in The Netherlands for patients with CRPS-1. There are two level C retrospective cohort studies…

A randomised, controlled, observer-blinded phase III clinical trial to compare the effect of intravenous ferric carboxymaltose to placebo on exercise capacity and cardiac function in patients with chronic heart failure and iron deficiency - EFfect of Ferric Carboxymaltose on exercIse CApacity and Cardiac function in patients with iron deficiencY and chronic Heart Failure

Secondary objectives are to evaluate the effect of intravenous FCM compared to pla¬cebo on:1. Evolution from baseline of cardiac function parameters as assessed by 2D Echo/Doppler cardiography 4, 12 and 24 weeks after start of study treatment.2.…

Multicentre, controlled, randomised, investigator-blinded, comparative study of oral Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS (MOTUS study)

Primary objective: To demonstrate that mesalazine po 4g per day once daily (QD.) is non-inferior to the reference regimen, mesalazine 4g per day in two divided doses (BID.) (2g x 2 per day), in patients with active ulcerative colitis treated for 8…

A randomised, double-blind, parallel-group, placebo-controlled phase III study to evaluate the efficacy and safety of desmoteplase in subjects with acute ischemic stroke.

The primary objective of the study is to evaluate the efficacy of desmoteplase 90µg/kg versus placebo in terms of favourable outcome at Day 90 in subjects with acute ischemic stroke. Secondary objectives are to evaluate: the efficacy of desmoteplase…

A Phase III Open-Label, Single-Group, Extension Study to
Obtain Long-Term Safety and Tolerability Data of
Idebenone in the Treatment of Friedreich*s Ataxia Patients

- To gather long-term data on the safety and tolerability of idebenone inFriedreich*s Ataxia- To explore the effect of idebenone after longer term administration onneurological symptoms and signs as assessed by the InternationalCooperative Ataxia…

An Open-label (OL) Extension Study evaluating the Long-Term Safety of OxabactTM in Subjects with Primary Hyperoxaluria (PH) who participated in the Double-Blind (DB) Efficacy Study

Primary Objective:To evaluate the Safety of OxabactTM with continued exposure.Secondary Objectives:To obtain additional efficacy data with up to 48 weeks continuous exposure to Oxabact*.

The effectiveness of intensive treatment on sympathetic hyperactivity. A randomized, cross-over trial in patients with chronic kidney disease and hypertension

The primary objective is to investigate if there is an incremental inhibiting effect on MSNA by increasing dosage valsartan above the presently advised dosage. We hypothesize that there will be a further decrease in MSNA as compared to the MSNA…

Intervention pilot study with FFP or the combination of fibrinogen concentrate and FFP to patients with massive (post) operative bloodloss.

In this study we will try to obtain the rise in value of fibrinogen concentrate infusion in combination with FFP vs FFP transfusion in surgery patients with massive peri-operative bleeding problems and cardiothoracic surgery patients after heart…

A Phase IIIB multicentre, randomized, double*blind, double dummy study to compare the efficacy and safety of abatacept administered subcutaneously and intravenously in subjects with rheumatoid arthritis, receiving background methotrexate, and experiencing an inadequate response to methotrexate.

The primary objective for this study is to demonstrate that SC injections of abatacept are non-inferior to IV infusions of abatacept .

Randomized study to assess the added value of Laromustine in combination with standard remission-induction chemotherapy in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or myelodysplasia (MDS) (RAEB with IPSS >= 1.5)

Primary objectivesPart A: To determine the feasibility of Laromustine when given at three possible dose levels together with standard induction cycles I and II in patients with AML/ RAEB with IPSS³1.5 in a prospective comparison to standard…

Platelet Transfusion in Cerebral Haemorrhage

The objective of our study is to investigate whether platelet transfusion within 6 hours after onset of ICH can improve functional outcome by limiting haematoma growth in patients using PAI.

Antiplatelet therapy in combination with Recombinant t-PA Thrombolysis in Ischemic Stroke

The objective of this trial is to investigate whether adding acute APT to rt-PA thrombolysis in ischemic stroke reduces death or dependency at 3 months.