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Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses

To document the long-term safety and tolerability of teriflunomide in MS patients with relapses.

An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis

Study CFTY720D2301E1 is designed to assess the following properties of FTY720 inpatients with relapsing MS:* To evaluate long-term safety and tolerability* To evaluate long-term efficacy

Randomized trial on chest irradiation in extensive disease small cell lung cancer

to evaluate the role of thoracic irradiation in patients with ED-SCLC who respond to chemotherapy and to assess the effect on 1 year survival

An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients with Prostate Cancer Requiring Androgen Deprivation Therapy

Primary Objective - To evaluate the time to PSA >4 ng/mL during the first cycle of IAD after the end of an induction period with degarelix (7 monthly treatments) in prostate cancer patientsSecondary Objectives - To evaluate the time to PSA .4…

A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy

The objectives of this study are to compare the safety and efficacy of 2 annual cycles of intravenous (IV) alemtuzumab to 3-times weekly subcutaneous (SC) interferon beta 1a (Rebif*) in patients with active relapsing-remitting multiple sclerosis (…

Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

BAY 63 2521 is a stimulator of the soluble guanylate cyclase (sGC) and is intended for the treatment of cardiovascular diseases, especially pulmonary hypertension (PH).To assess the efficacy and safety of oral BAY 63 2521 in patients with inoperable…

Multicenter, randomized, double-blind, phase III trial to investigate the efficacy and safety of oral BIBF 1120 plus standard pemetrexed therapy compared to placebo plus standard pemetrexed therapy in patients with stage IIIB/IV or recurrent non small cell lung cancer after failure of first line chemotherapy

To investigate the efficacy and safety of BIBF 1120 as compared to placebo in patients with stage IIIB/IV or recurrent non small cell lung cancer treated with standard therapy of pemetrexed after failure of first line chemotherapy.

Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

BAY 63 2521 is a stimulator of the soluble guanylate cyclase (sGC) and is intended for the treatment of cardiovascular diseases, especially pulmonary hypertension (PH).To assess the longterm safety and tolerability of oral BAY 63-2521 in patients…

A Prospective, Randomized, Open-Label, Parallel-Group, Multicenter Study
to Demonstrate the Superiority of Matrix-induced Autologous Chondrocyte Implantation (MACI® Implant) versus Arthroscopic Microfracture for the
Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle including the Trochlea.

The objective of this study is to demonstrate superior efficacy and evaluate the safety of MACI Implant compared with arthroscopic microfracture in the treatment of patients (aged 18 to 55 years old) with symptomatic articular cartilage defects of…

A Randomized Study of Stopping Treatment at 24 Weeks or Continuing Treatment to 48 Weeks in Treatment-Naïve Subjects with Genotype 1 Chronic Hepatitis C who Achieve an Extended Rapid Viral Response (eRVR) While Receiving Telaprevir, Peginterferon Alfa2a (Pegasys®) and Ribavirin (Copegus®)

Primary:To estimate the difference in SVR rates between T12/PR24 and T12/PR48 treatment regimens in subjects who achieve eRVR.Secondary:To evaluate the safety of telaprevir in combination with Peg-IFN-alfa-2a and RBV in treatment-naïve subjects with…

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Carisbamate as Adjunctive Therapy in Subjects With Partial Onset Seizures, Followed by an Open-Label Extension Study

Double-Blind Study CARISEPY3013:The primary objectives of this study are to compare the efficacy safety, and tolerability of carisbamate as adjunctive treatment of partial onset seizures, relative to placebo. The secondary objectives of this study…

A Phase III, randomised, parallel group, double-blind, double-dummy, active comparator -controlled, multi-center study to assess the efficacy and safety of PGL4001 (ulipristal) versus GnRH-agonist (leuprorelin 3.75mg) for pre-operative treatment of symptomatic uterine myomas.

Efficacy Objectives:- Primary objective of this study is to demonstrate non inferior efficacy of PGL4001 versus GnRH-agonist to reduce, prior to surgery, excessive uterine bleeding caused by uterine myomas.- Secondary objectives are to demonstrate…

A multi-center, parallel-group, comparative trial evaluating the efficacy, pharmacokinetics and safety of 4.0 mg.kg-1 sugammadex administered at 1-2 PTC in subjects with normal or severely impaired renal function

Objective is to show equivalence with respect to the efficacy of sugammadex in subjects with normal or severely impaired renal function, to evaluate the safety of sugammadex in these subject groups and to compare the pharmacokinetic profiles.

Prevention of constipation during treatment with opioids: magnesiumoxide versus macrogol/elektrolytes

The aim of the study is to compare magnesiumhydroxide and polyethylene glycol/electrolytes with regard to the prevention of constipation and side-effects in palliative care cancer patients starting with opioids.

A 6-month, double-blind, randomized, placebo-controlled, parallel group outpatient trial, investigating the efficacy and safety of Org 50081 in adult patients with chronic primary insomnia.

Primary: To demonstrate the long-term efficacy of treatment with Org 50081, as compared to placebo, on sleep maintenance in patients with chronic primary insomnia as measured by the subjective Total Sleep Time. Primary efficacy endpoint is the…

Comparative efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukemia (ALL), a phase III clinical trial

This multicentre phase III study is designed to assess the efficacy and safety of recombinant versus E-Coli derived Aaparaginase from Medac, during treatment of children with newly diagnosed ALL according to the DCOG ALL-10 protocol.Futhermore: To…

A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults.

To assess non-inferiority of a regimen containing ritonavir-boosted elvitegravir versusraltegravir, each administered with a background regimen in HIV-1 infected,antiretroviral treatment-experienced adult subjects as determined by the proportion…

Rivastigmine for delirium in Intensive Care patients, a double-blind, randomised, placebo-controlled, multi-center add-on trial

To study whether rivastigmine added to treatment with haloperidol shortens the duration of delirium in ICU patients and reduces costs.

HEART OUTCOMES PREVENTION EVALUATION (HOPE) - 3

The HOPE-3 trial will evaluate the effects of lipid modification with rosuvastatin and of blood pressure lowering with candesartan/hydrochlorothiazide (HCT) and their combination in a wide range of middle aged people, who are at average risk for…

A Phase IIIB, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis.

Primary Objective:To assess the clinical response rate as measured by American College of Rheumatology 20% (ACR20) response rate at Week 12.Secondary Objective:• To assess:- for all patients at Week 12, and every 8 weeks and at the completion/…