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NCT ID: NCT01119859 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis

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

This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.

NCT ID: NCT01119300 Completed - Atrial Fibrillation Clinical Trials

EUropean Pharmacogenetics of AntiCoagulant Therapy - Warfarin

EU-PACT
Start date: January 2011
Phase: Phase 4
Study type: Interventional

Rationale: The narrow therapeutic range and wide inter-patient variability in dose requirement make anticoagulation response to coumarin derivatives unpredictable. As a result, patients require frequent monitoring to avert adverse effects and maintain therapeutic efficacy. Polymorphisms in cytochrome P450 2C9 (CYP2C9) and vitamin K epoxide reductase complex 1 (VKORC1) jointly account for about 40% of the inter-individual variability in dose requirements. To date, several pharmacogenetic guided dosing algorithms for coumarin derivatives, predominately for warfarin, have been developed. However, the potential benefit of these dosing algorithms in terms of their safety and clinical utility has not been adequately investigated in randomised settings. Objective: To determine whether a dosing algorithm containing genetic information increases the time within therapeutic INR range during anticoagulation therapy with each of warfarin, acenocoumarol and phenprocoumon compared to a dosing regimen that does not contain this information. Secondary outcomes of the study include cost effectiveness, number of thromboembolic and bleeding events, time to reach stable dose and number of supratherapeutic INR peaks.

NCT ID: NCT01117350 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure

EAGLE
Start date: July 2010
Phase: Phase 4
Study type: Interventional

Primary objective: To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of patients reaching a Glycosylated Haemoglobin (HbA1c) < 7% at the end of the comparative period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents Secondary objectives of the comparative period (24 weeks): >To assess the effect of insulin glargine in comparison with liraglutide on: - HbA1c level - Percentage of patients whose HbA1c has decreased but remains >= 7% at the end of the comparative period - Percentage of patients whose HbA1c has increased at the end of the comparative period - Fasting Plasma Glucose (FPG) - 7-point Plasma Glucose (PG) profiles - Hypoglycemia occurrence - Body weight - Adverse events Objectives of the extension period (24 weeks): >To assess the effect of insulin glargine in patients not adequately controlled with liraglutide on: - HbA1c level - FPG - 7-point PG profiles - Hypoglycemia occurrence - Body weight - Adverse events

NCT ID: NCT01115166 Completed - Clinical trials for Blood Volume, Extravasation

Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation

Start date: May 2010
Phase: N/A
Study type: Observational

In patients undergoing extracorporal circulation during cardiac operation, the hemoglobin is subjected to large changes. The purpose of this study is to see if it is possible with the help of volume kinetic techniques to use these variations to measure blood volume and fluid escape from the intravascular volume.

NCT ID: NCT01113424 Completed - Tobacco Dependence Clinical Trials

Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum

Start date: September 2008
Phase: N/A
Study type: Interventional

Bioequivalence between oral nicotine replacement products and Nicorette® gum.

NCT ID: NCT01112865 Completed - Clinical trials for Growth Hormone Deficiency

Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects

CHOOSE
Start date: August 2010
Phase: Phase 3
Study type: Interventional

Convenience and preference for the new Mark VII pen compared to the current Genotropin pen will be assessed using a questionaire. it is expected that the new pen will be preferred or at least no different to the current pen.

NCT ID: NCT01112644 Completed - Clinical trials for Moderate to Severe Idiopathic RLS With Daytime Symptoms

Oxycodone/Naloxone Prolonged Release (OXN PR) Compared to Placebo to Demonstrate Improvement in Symptoms of Restless Legs Syndrome (RLS) in Subjects With Moderate to Severe Idiopathic RLS With Daytime Symptoms

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

The primary objective for the 12-week Titration-/Maintenance Period is: To demonstrate superior efficacy of OXN PR compared to PLA in the improvement of symptom severity of RLS.

NCT ID: NCT01112579 Completed - Heart Failure Clinical Trials

Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure

DEFEAT-HF
Start date: April 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic heart failure.

NCT ID: NCT01112306 Completed - Clinical trials for Pulmonary Arterial Hypertension

ACT-293987 in Pulmonary Arterial Hypertension

Start date: July 7, 2010
Phase: Phase 3
Study type: Interventional

Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)

NCT ID: NCT01110811 Completed - Clinical trials for Gastroesophageal Reflux Disease

Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD)

Start date: April 2010
Phase: N/A
Study type: Interventional

The study objective is to evaluate the relative merits, safety and effectiveness of transoral incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients compared with sham procedure.