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NCT ID: NCT00751881 Completed - Multiple Sclerosis Clinical Trials

An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis

TOWER
Start date: August 2008
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess the effect of two doses of Teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in patients with relapsing MS. Key secondary objective is to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression. Other secondary objectives are: - To assess the effect of the two doses of teriflunomide in comparison to placebo on: - Fatigue; - Health-related quality of life, a measure of the impact of the patient's health on his or her overall well being. - To evaluate the safety and tolerability of teriflunomide.

NCT ID: NCT00751231 Completed - Clinical trials for Percutaneous Coronary Intervention

A Phase 2 Safety and Efficacy Study of PRT060128, a Novel Intravenous and Oral P2Y12 Inhibitor, in Non-Urgent PCI

INNOVATE-PCI
Start date: December 2008
Phase: Phase 2
Study type: Interventional

This is a multi-center, randomized, double-blind, triple-dummy, clopidogrel-controlled study of IV and oral PRT060128 compared to clopidogrel in patients undergoing non-urgent (including elective) PCI. After diagnostic angiography, patients scheduled for non-urgent PCI will be randomized to clopidogrel or to one of three dose levels of PRT060128.

NCT ID: NCT00751114 Completed - Clinical trials for Diabetes Mellitus, Type 2

Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients

EASIE
Start date: November 2008
Phase: Phase 4
Study type: Interventional

The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period. Secondary objective was to assess the effect of insulin glargine in comparison with sitagliptin on: - HbA1c level - Fasting Plasma Glucose (FPG) - 7-point plasma glucose (PG) profiles - Percentage of patients with HbA1c <7% and <6.5% Safety objectives consisted of: - Hypoglycemia occurrence - Body weight - Overall safety

NCT ID: NCT00750880 Completed - Clinical trials for Rheumatoid Arthritis

An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.

Start date: September 2008
Phase: Phase 3
Study type: Interventional

This open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive tocilizumab 8mg/kg iv as a 60 minute infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is >500 individuals.

NCT ID: NCT00749190 Completed - Clinical trials for Diabetes Mellitus, Type 2

BI 10773 add-on to Metformin in Patients With Type 2 Diabetes

Start date: August 2008
Phase: Phase 2
Study type: Interventional

The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.

NCT ID: NCT00741806 Completed - Influenza Clinical Trials

Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults

GHB-CS03
Start date: August 2008
Phase: Phase 1
Study type: Interventional

It is the hypothesis of this study that intranasal vaccination with a single dose of GHB04L1 is safe and induces an immune response against influenza A H5N1. This hypothesis will be tested in a randomized, double-blind, placebo-controlled, Phase I dose-escalation study assessing the safety and tolerability of single dose administration of GHB04L1 in healthy adults. Furthermore, the local and systemic immune response as well as the pharmacokinetic properties of a single dose of GHB04L1 will be studied as secondary objectives. GHB04L1 will be escalated according to a fixed dose escalation scheme comprising three dose levels.

NCT ID: NCT00740831 Completed - Uterine Myomas Clinical Trials

PGL4001 Versus GnRH-agonist in Uterine Myomas

PEARLII
Start date: August 2008
Phase: Phase 3
Study type: Interventional

This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

NCT ID: NCT00739635 Completed - Subjective Tinnitus Clinical Trials

Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus

EASE
Start date: September 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.

NCT ID: NCT00738829 Completed - Clinical trials for Leukemia, Lymphocytic, Chronic, B-Cell

Lenalidomide Dose Escalation Combined With Rituximab/Fludarabine in Untreated CLL

Start date: October 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this study is to determine the maximal tolerated dose level of lenalidomide combined with fludarabine/rituximab in the therapy of patients with previously untreated CD20-positive chronic lymphocytic leukemia. Following a dose escalation phase lenalidomide will be given at the pre-determined maximum tolerated dose in combination with rituximab to further determine the efficacy and tolerability of this regimen.

NCT ID: NCT00738686 Completed - Clinical trials for Coronary Artery Disease

Austrian Multivessel Taxus-Stent Registry

AUTAX
Start date: June 2004
Phase: Phase 4
Study type: Interventional

The aim of AUTAX study is to investigate the frequency of MACCE in patients with multivessel disease and multiple Taxus stent implantations in the "real world" stenting at 30 days, 6 and 12 months at 2 year follow-up. Because multivessel stenting using DES has been limited due to economic considerations, the secondary aim is to enhance experience in multivessel stenting with drug-eluting stents in order to improve short- and long-term outcomes of the patients with severe multiple coronary artery stenoses. The objectives of the study are: 1. To determine the frequency of MACCE at 30-day, 6 and 12-month and at 2 year clinical follow-up after multivessel intervention with drug-eluting stents in a prospective patient cohort.. 2. To determine the rate of in-stent restenosis, target lesion and target vessel revascularization (angiographic measures) 6 months in patients with multiple DESs in multiple lesions. 3. To investigate the clinical and angiographic outcomes after implantation of multiple DESs in the subgroup of patients with accompanying diseases (diabetes mellitus, renal insufficiency) with known high restenosis and late complication rate. 4. To evaluate potential cost burden in attempting a strategy of complete revascularization by multiple DES in patients with multivessel disease.