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NCT ID: NCT01187862 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetic Study to Investigate Low-dose Combinations of a Cocktail of Seven Drugs for Simultaneous Phenotyping of Cytochromes

Start date: July 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess whether a cocktail of seven approved drugs (so-called "Basel cocktail") can be used for simultaneous phenotyping of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4.

NCT ID: NCT01187849 Completed - Clinical trials for Patients With Glucocorticoid Treatment

Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

Start date: August 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate if a treatment with metformin compared to placebo reduces metabolic side-effects in patients with glucocorticoid treatment over three months time.

NCT ID: NCT01185821 Completed - Clinical trials for Relapsing Remitting Multiple Sclerosis

Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple Sclerosis

Start date: August 30, 2010
Phase: Phase 2
Study type: Interventional

This study consisted of a two year dose blinded phase during which patients received one of five doses of siponimod (10, 2, 1.25, 0.5 or 0.25mg) following which patients were switched to open label treatment with siponimod 2mg for approximately a further 3 years. It will provide data on long term safety, tolerability and efficacy of siponimod in the RRMS patient population

NCT ID: NCT01183858 Completed - Clinical trials for Non-Small Cell Lung Cancer

A Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS)

Start date: October 2010
Phase: Phase 3
Study type: Interventional

This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib [Tarceva] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression.

NCT ID: NCT01183247 Completed - Clinical trials for Immunosuppressive Agents

An Open, Single Centre, Randomised, Parallel Group Study to Investigate Three Different Immunosuppressive Regimens

SterFreePlus
Start date: July 2008
Phase: Phase 4
Study type: Interventional

An open, single center, randomised study to investigate three different immunosuppressive regimens for de novo renal transplant recipients: 1. st sirolimus / EC-MPS / tacrolimus regimen - After 3 months a protocol biopsy is performed. If no rejection is detected the calcineurin inhibitor (tacrolimus) is withdrawn. 2. nd everolimus / EC-MPS / tacrolimus regimen - After 3 months a protocol biopsy is performed. If no rejection is detected the calcineurin inhibitor (tacrolimus) is withdrawn. 3. rd tacrolimus / EC-MPS / prednisone regimen - After 3 months a protocol biopsy is performed. If no rejection is detected prednisone is withdrawn.

NCT ID: NCT01182792 Active, not recruiting - Chronic Clinical Trials

Chronic Mountain Sickness, Systemic Vascular Function

CMS
Start date: October 2008
Phase: N/A
Study type: Interventional

Diseases associated with chronic hypoxemia like chronic obstructive pulmonary disease (COPD) or emphysema, represent major medical and socio-economical problems and one of the leading cause of morbidity and mortality in the western countries. Recently, is has been shown that cardiovascular (CV) diseases contribute highly to the morbidity and mortality of these patients. Furthermore, increasing evidence suggest that systemic vascular dysfunction play a central role in the mediation of the increased CV risk in patients with COPD. However the underlying mechanisms of vascular dysfunction in these patients are incompletely understood. Chronic mountain sickness (CMS) is characterized by chronic hypoxemia related at least in part to hypoventilation; it affects relatively young adults, and may therefore allow to study the effects of chronic hypoxemia. The investigators therefore will assess systemic vascular function and test the hypothesis that increased oxidative stress is responsible for this dysfunction. Since polyglobulia is a hallmark of chronic hypoxemia and has been suggested to affect vascular function, the investigators will test the effects of hemodilution on vascular function. Then, the investigators will test the effects of acute oxygen application and 1 month antioxidative dietary supplement on vascular function. Preliminary data suggest that offspring of CMS patients may display pulmonary and systemic vascular dysfunction. Antioxidant administration is know to improve vascular function. We will test the acute effect of Vitamin C in this setting. Finally, since there is considerable inter-individual variability of pulmonary artery pressure among CMS patients and the presence of a patent foramen ovale (PFO)is increased in clinical conditions associated with pulmonary hypertension and hypoxemia, we will assess the prevalence of PFO in healthy high altitude dwellers and in CMS patients and its effects on pulmonary artery pressure at rest and during mild exercise.

NCT ID: NCT01182428 Completed - Clinical trials for Coronary Artery Disease

XIENCE V: SPIRIT WOMEN Sub-study

Start date: September 2008
Phase: Phase 4
Study type: Interventional

The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIMEā„¢ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.

NCT ID: NCT01181128 Completed - Severe Hemophilia A Clinical Trials

Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A

Start date: November 2010
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical treatment regimen; to evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm 1); to evaluate the efficacy of rFVIIIFc administered as an on-demand (Arm 3) and surgical treatment regimen. The secondary objectives of this study are: to characterize the PK profile of rFVIIIFc and compare the PK of rFVIIIFc with the currently marketed product, Advate®; to characterize the range of dose and schedules required to adequately prevent bleeding in a prophylaxis regimen, maintain hemostasis in a surgical setting, or to treat bleeding episodes in an on-demand, weekly treatment, or prophylaxis setting.

NCT ID: NCT01180439 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Patient-Ventilator Interactions in Chronic Obstructive Pulmonary Diseases (COPD) Under Non-Invasive Ventilation

Start date: October 2009
Phase: N/A
Study type: Interventional

Non-invasive ventilation (NIV) in severe hypercapnic Chronic Obstructive Pulmonary Diseases (COPD) may be associated - during sleep - with recurrent episodes of patient ventilatory asynchrony, which in turn may affect quality of sleep, efficacy of ventilation and comfort of nocturnal NIV.Polysomnography (PSG) under NIV is necessary to detect these events. Adjusting ventilator settings according to respiratory events detected by PSG with NIV may improve quality of sleep, efficacy of ventilation and comfort of nocturnal NIV.

NCT ID: NCT01179828 Completed - Low Back Pain Clinical Trials

Linking Altered Central Pain Processing and Genetic Polymorphism to Drug Efficacy in Chronic Low Back Pain (Predictio)

Predictio
Start date: July 2010
Phase: Phase 3
Study type: Interventional

Drug therapy in patients with chronic low back pain is a major challenge for physicians. One of the problems is the lacking knowledge in prediction of drug efficacy in a chosen patient. Usually one of the classes of pain medication is given to patients with a similar clinical picture, although different pain mechanisms may be responsible for this clinical picture. Another reason for variable drug efficacy are genetic polymorphisms, this may be the reason why an unique drug produces different responses (from a lacking analgesic effect up to excessive effect or side-effects. Quantitative sensory testing is a method that documents alterations in the pain perception system. Linking genetic polymorphisms to quantitative sensory testing may give us a tool for anticipation of drug efficacy.