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NCT ID: NCT01440257 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study to Evaluate the Effect of CCX140-B on Urinary Albumin Excretion in Subjects With Type 2 Diabetes and Albuminuria

Start date: September 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect of treatment with CCX140-B on urinary albumin excretion in subjects with type 2 diabetes mellitus and albuminuria, as well as to study the safety and efficacy of the medication in this patient population.

NCT ID: NCT01439880 Completed - Clinical trials for Hypercholesterolemia

Open Label Study of Long Term Evaluation Against LDL-C Trial

OSLER
Start date: October 7, 2011
Phase: Phase 2
Study type: Interventional

The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.

NCT ID: NCT01439490 Completed - Clinical trials for Epithelial Ovarian Cancer

FES-PET to Determine ER-expression in Epithelial Ovarian Cancer

Start date: August 2011
Phase: Phase 2
Study type: Interventional

Estrogens are implicated in the development of ovarian cancer and estrogen receptors (ER) alpha and beta are present in 20-100% of ovarian cancer patients. For this reason, antihormonal therapy with anti-estrogens or ER-antagonists is potentially an attractive treatment option. However, only a small proportion of patients (5-19%) will respond to antihormonal therapy. ER-expression in ER-positive breast cancer can be assessed by positron emission tomography (PET) with [18F]fluoroestradiol (FES). In this study the investigators will evaluate whether FES-PET can be used to visualize and quantify ER-expression in ovarian cancer. If these results are positive, this would warrant further exploration of FES-PET imaging in ovarian cancer.

NCT ID: NCT01439308 Completed - Rhinitis Clinical Trials

Intranasal SB-705498 in Non-allergic Rhinitis Patients

Start date: December 2009
Phase: Phase 2
Study type: Interventional

This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by capsaicin challenge

NCT ID: NCT01438840 Completed - Clinical trials for Immune Thrombocytopenia

Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults With Chronic Immune Thrombocytopenia (Amendment 02)

Start date: February 16, 2012
Phase: Phase 3
Study type: Interventional

Core Study: To demonstrate that the efficacy of avatrombopag (in addition to standard of care) is superior to placebo (in addition to standard of care) for the treatment of adult participants with chronic immune thrombocytopenia (idiopathic thrombocytopenic purpura) (ITP) as measured by cumulative number of weeks of platelet response over 6 months of once daily treatment in adults participants who received at least 1 prior ITP therapy. Extension Phase: To evaluate the safety and tolerability of long-term therapy with avatrombopag in participants with chronic ITP (cITP).

NCT ID: NCT01438723 Completed - Clinical trials for Cardiovascular Disease

The Metformin in Coronary Artery Bypass Graft (CABG) (MetCAB) Trial

MetCAB
Start date: November 2011
Phase: Phase 4
Study type: Interventional

Rationale: In patients with a myocardial infarction, occlusion of a coronary artery induces myocardial ischemia and cell death. If untreated, the area of myocardium exposed to this interruption in blood supply, will largely become necrotic. The only way to limit final infarct size, is timely reperfusion of the occluded artery. Paradoxically, however, reperfusion itself can also damage myocardial tissue and contribute to the final infarct size ("reperfusion injury"). Also during coronary artery bypass grafting (CABG), the myocardium is exposed to ischemia and reperfusion, which will induce cell death. Indeed, postoperatively, the plasma concentration of troponin I, a marker of cardiac necrosis, is increased, and associated with adverse outcome. The anti-hyperglycaemic drug metformin has been shown in preclinical studies to be able to reduce ischemia-reperfusion injury and to limit myocardial infarct size. Moreover, metformin therapy improves cardiovascular prognosis in patients with diabetes mellitus. Paradoxically, in patients with diabetes, current practice is to temporarily stop metformin before major surgery for the presumed risk of lactic acidosis, which is a rare complication of metformin. However, here is no evidence that this practice benefits the patient. The investigators hypothesize that pretreatment with metformin can reduce myocardial injury in patients undergoing elective CABG surgery

NCT ID: NCT01438632 Completed - Diabetes Mellitus Clinical Trials

Pharmacology of Insulin Injected With Jet-injection in Diabetes

Start date: September 2011
Phase: Phase 4
Study type: Interventional

A previous study showed that absorption and glucose-lowering action of rapid-acting insulin analogues occurred twice as fast when these analogues were administered by jet injection technology rather than by conventional insulin pen in healthy non-diabetic subjects. This study investigates if the rapid-acting insulin analogue aspart (Novorapid®) injected with jet-injection or a conventional insulin pen prior to a standardised meal in patients with diabetes shows the same difference in the pharmacokinetic and pharmacodynamic profile.

NCT ID: NCT01438463 Completed - Allergic Rhinitis Clinical Trials

PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis

Start date: September 2011
Phase: Phase 2
Study type: Interventional

The objective of the present study is to characterize the dose-response relationship of PURETHAL® Mites with a nasal provocation test in order to support the optimal dose in terms of clinical efficacy and safety. For this purpose 5 groups of 50 patients, suffering from rhinitis or rhinoconjunctivitis due to House Dust Mite Allergy will be treated during 1 year. Before start, after 6 months of treatment and at the end of the study patients will be subjected to a nasal provocation test.

NCT ID: NCT01438086 Completed - Heart Failure Clinical Trials

Evaluation of the Safety and Efficacy of Using Insulin-like Growth Factor-1 in Patients With a Heart Attack

RESUS-AMI
Start date: October 2011
Phase: Phase 1/Phase 2
Study type: Interventional

When a patient has a heart attack, a blockage occurs in a coronary artery that delivers oxygen to the heart muscle. The heart muscle may weaken, causing heart failure. The body naturally makes a protein called insulin-like growth factor-1 (IGF-1) that may protect the heart muscle cells from dying and may prevent heart failure or lessen the damage that occurs. IGF-1 is also available as a drug called mecasermin. In this study, heart attack patients will be given either a dose of mecasermin or a placebo (inactive treatment) after their coronary artery has been opened by a stent. The purpose of the study will be to evaluate the safety of the therapy and to test if the therapy will prevent or lessen heart failure by evaluating a cardiac magnetic resonance imaging (MRI) taken one day and eight weeks after the heart attack.

NCT ID: NCT01437865 Completed - Breast Neoplasms Clinical Trials

Gadofosveset for Axillary Staging in Breast Cancer Patients

Start date: September 2011
Phase: N/A
Study type: Interventional

The aim of this pilot-study is to examine the accuracy of gadofosveset enhanced MRI compared to current nodal staging methods. The accuracy of MRL will be determined on the basis of a node-to-node matching of imaged nodes to the definitive histopathology. The pathologic examination of the SNLB or ALND will be regarded as the golden standard for nodal involvement.