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A prospective, double-blind, placebo-controlled trial investigating the efficacy and safety of Org 25935 in relapse prevention in subjects with alcohol dependence

Primary objective- To assess the effects of Org 25935 on heavy drinking in subjects with alcohol dependence.Secondary objectives- assess the effects of Org 25935 on the amount of drinking- To assess the effects of Org 25935 on the first relapse to…

A Five-Tier, Phase 2 Open-Label Study of IMC-A12 Administered
as a Single Agent Every 2 Weeks in Patients With Previously-
Treated, Advanced or Metastatic Soft Tissue and Ewing's
Sarcoma/PNET

The primary objective of this study is to determine the progression-free survival (PFS) rate assessed 12 weeks after the initiation of IMC-A12 monotherapy, administered every 2 weeks to patients with previously-treated, advanced or metastatic soft…

A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course.

Primary Objective: • The primary objective of the study is to evaluate the efficacy of three doses of atacicept to reduce CNS inflammation in subjects with RMS as assessed by frequent MRI.Secondary Objectives: • Evaluate safety and tolerability of…

Autophagy inhibition using hydrochloroquine in breast cancer patients: a pilot study

Primary objective is to assess differences in endogenous hypoxia markers (CA9, PAI-1, VEGF [Rademakers et al. 2008]) and autophagy (LC3b [Rouschop et al. 2010]) before and after short-term pre-surgical treatment with HCQ in breast cancer patients.…

Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination
with Mitoxantrone and Prednisone in Subjects with Previously Treated Castrate Resistant Prostate Cancer

The objective of the study (phase 2) is to evaluate the effectiveness of AMG 102 in combination with Mitoxantrone and Prednisone in previously treated subjects with castrate resistant prostate cancer.

Clinical and immunological effects of imiquimod and HPV-vaccination compared to imiquimod alone in female patients with Usual type VIN: proof of principle.

Primary objectives: (1) Evaluation of the efficacy of vaccination against HPV 16, 18, 6 and 11 followed by local applications of imiquimod 5% cream compared to treatment with imiquimod alone for usual type VIN, (2) evaluation of the systemic and…

Phase II study of sunitinib (SU011248) in patients with small cell lung cancer who are either chemo-naïve (extensive disease) or have a "sensitive" relapse

To assess the therapeutic activity of SU11248 in patients with exptensive disease small cell lung cancer who are either chemonaive or have a sensitive relapse

A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm,
Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of Teplizumab
(MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in
Children and Adults with Recent-Onset Type 1 Diabetes Mellitus

Primary:The primary objective of this study is to assess, relative to placebo, the efficacy, tolerability, andsafety of teplizumab when administered according to 3 different teplizumab dosing regimens insubjects with recent-onset (onset within past…

A Randomised, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Clinical Events and Biomarkers in Patients with Non-ST-Segment Elevation Acute Coronary Syndrome

The primary objectives of the study are to investigate the safety and tolerability of E5555 at three dose levels in patients admitted to hospital with symptoms of Acute Coronary Syndrome (ACS). This will be assessed for a period of up to 16 weeks (…

A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis

In patients with primary biliary cirrhosis (PBC) taking UDCA, to assess the effects of INT-747 on: Primary: - Alkaline phosphatase (AP) levels - SafetySecondary: - Hepatocellular injury and liver function - Disease-specific and general health…

A RANDOMIZED PHASE II STUDY OF CONCOMITANT TRASTUZUMAB, BEVACIZUMAB WITH PACLITAXEL VERSUS TRASTUZUMAB AND BEVACIZUMAB FOLLOWED BY THE COMBINATION OF TRASTUZUMAB, BEVACIZUMAB AND PACLITAXEL AT PROGRESSION AS FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC BREAST CANCER WITH HER2-NEU OVEREXPRESSION

Primary objective: To establish whether concomitant therapy of trastuzumab, bevacizumab with paclitaxel (regimen A) and/or trastuzumab and bevacizumab followed by the combination of trastuzumab, bevacizumab, and paclitaxel at progression (regimen B…

A phase II study of docetaxel/carboplatin as secondline treatment in patients with refractory or relapsed SCLC

To evaluate the anti-tumor activity of a docetaxel/carboplatin regimen in patients with refractory or relapsed SCLC. Furthermore to asses the safety profile of the docetaxel/carboplatin combination.In patients who have experienced FN, the efficacy…

Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination with Methotrexate, Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Primary Objective:To preliminarily evaluate the efficacy of GLPG0259 compared with placebo in terms of the proportion of subjects achieving ACR20 at Week 12 (Visit [V]7).Secondary Objectives:•To evaluate the efficacy of GLPG0259 compared with…

Multicenter, open-label, randomized study to evaluate inhibition of ovulation during treatment with three transdermal patch formulations containing 0.55 mg ethinylestradiol (EE) and 2.10 mg gestodene (GSD) or 0.35 mg EE and 0.67 mg GSD or 0.275 mg EE and 1.05 mg GSD in healthy young female volunteers over a period of 3 treatment cycles

Objective of this study is the evaluation of contraceptive patches with EE and GSD. The inhibition of ovulation of three different patch formulations will be evaluated. Secondary objectives are the course of gonadotropins, estradiol and progesterone…

A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding Trial of Microplasmin Intravitreal Injection for Non-Surgical PVD Induction for Treatment of Diabetic Macular Edema.

The purpose of this study is to evaluate if microplasmin is safe and effective when injected into the vitreous without performing a vitrectomy.

A randomised, double-blind, active-controlled, double-dummy, parallel group study to determine the safety and efficacy of oxycodone / naloxone prolonged release tablets in subjects with moderate to severe, chronic cancer pain

To determine the improvement in symptoms of constipation in subjects receiving treatment with oxycodone/naloxone prolonged release tablets (OXN) compared to subjects receiving oxycodone prolonged release tablets (OXY) based on the Bowel Function…

A phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis

to offer continuation of BIBF 1020 treatment for patients with IPF who have completed a prior clinical trial with that drug.establish the long term tolerability and safety profile of BIBF 1120 in IPF.

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Antiviral Activity of SPC3649 (miravirsen) Administered to Treatment-Naïve Subjects with Chronic Hepatitis C (CHC) Infection

Main objectiveTo determine the safety and tolerability of multiple dosing of miravirsen in subjects infected with CHC.Secondary objectivesTo assess the pharmacokinetics (PK) of multiple dosing of miravirsen administered subcutaneously to subjects…

Tryptophan enriched diet to improve affective and cognitive functions in patients with multiple sclerosis

The purpose of this study is to test the acute effects of a TRP enriched meal in a dose-dependent manner in MS patients. The results of MS patients without mood disturbances (control group) will be compared to MS patients with mood disturbances (…

A Phase 2a, Single-Center Study Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/ Pharmacodynamics of Oral Tolvaptan in Subjects with Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal Function

The purpose of the trial is to determine the effect of multiple doses of tolvaptan on renal function in patients with autosomal dominant polycystic kidney disease (ADPKD) at various stages of renal function. Additionally, the short-term renal…