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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…

Concurrent ONce-daily VErsus twice-daily
RadioTherapy: A 2-arm randomised controlled trial of
concurrent chemo-radiotherapy comparing twice-daily
and once-daily radiotherapy schedules in patients with
limited stage small cell lung cancer (SCLC) and good
performance status.

To compare the primary endpoint (overall survival) between the two arms of the studySecondary endpoints are:Local progression-free survivalMetastases-free survivalCTCAE v3.0 toxicityChemotherapy dose intensityRadiotherapy dose intensity

Hypnotherapy for adolescents and adults with inflammatory bowel disease and symptoms compatible with irritable bowel syndrome

To study the effectiveness of gut-directed hypnotherapy in the treatment of IBS-like symptoms in patients with inflammatory bowel disease.

A randomized, double-blind phase 3 study of gemcitabine plus AG-013736 versus gemcitabine plus placebo for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer

Primary Objective: Compare the overall survival (OS) of patients receiving gemcitabine plus AG-013736 versus gemcitabine plus placebo.Secondary Objectives: 1. Compare the progression free survival (PFS) of patients in each arm;2. Compare the…

A randomized phase III study of adjuvant chemotherapy in patients with completely resected Non-Small-Cell Lung Cancer and low risk for recurrence: NVALT-8A

The primary aim of the study is to investigate whether it is possible to select patients by PET in a good prognosis group (i.e. low SUV) who will not benefit from adjuvant chemotherapy.

Evaluation of the Safety and Efficacy of Short-term A 002 Treatment in Subjects with Acute Coronary Syndromes

The objective of this study is to evaluate the safety and efficacy of A-002 when added to atorvastatin plus standard-of-care in subjects with an ACS. Specifically this study will examine the effect of treatment on morbidity and mortality as defined…

Perindopril arginine/Amlodipine versus Valsartan/Amlodipine antihypertensive startegies: Efficacy and safety in mild to moderate hypertensive patients. A randomised, double blind 6-month study followed by 8-month open label long-term follow-up with Perindopril arginine/Amlodipine.

To assess the efficacy of blood pressure lowering and the safety of increasing doses of perindopril and amlodipine combination and to compare them to another validated antihypertensive strategy using valsartan and valsartan combined to amlodipine.

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACODYNAMICS OF AT1001 IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS

The purpose of this study is to compare the effect of AT1001 (migalastat hydrochloride) versus placebo on GL-3 in the kidney.

A Randomized Phase 3 Study of Tasisulam Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle vs. Paclitaxel as Second-Line Treatment in Patients with Metastatic Melanoma

The primary objective of this study is to compare the overall survival (OS) of patients whohave received one prior regimen of dacarbazine or temozolomide-based chemotherapy for metastaticmelanoma when treated with either tasisulam or paclitaxel.The…

An open label, multi-center, phase 3 study with corresponding blinded image reading to determine the efficacy and safety of a single intravenous injection of 0.1 mmol/kg body weight of gadobutrol 1.0 molar (Gadovist®) in patients with newly diagnosed breast cancer referred for contrast-enhanced breast MRI

To assess the effectivity and safety of 1.0 molar gadobutrol (Gadovist®) for breast MRI

A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension

Primary: To assess the effect of UT-15C sustained release (SR) on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 12) in subjects with PAH who are not currently receiving ERA, PDE-5…

Efficacy and tolerability of Citrus/Cydonia comp.® 1% solution for injection in patients with grass pollen seasonal allergic rhinitis: A randomised, double-blind, placebo-controlled clinical trial

1. Clinically relevant reduction of symptom severity by use of Citrus/Cydonia comp. subcutaneous injections2. To examine the safety of treatment3. To examine treatment effects on immunological parameters4. To develop and validate an immunological…

Exploratory trial on intra-articular etanercept treatment in inflammatory arthritis

The primary objective is to determine if intra-articular etanercept therapy reduces the clinical signs and symptoms of inflammatory arthritis and improve outcome (beneficial effect). The secondary objective is to study safety and to analyse…

Efficacy and Safety of Epanova® in Severe Hypertriglyceridemia

The purpose of this study is to see the effects of three different doses of Epanova on Triglyceride levels of 332 patients with severe hypertriglyceridemia, compared to placebo. The study will also try to determine how much Epanova is needed to have…

A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 2)

The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with moderate to severe general SLE despite standard of care treatments (ie, corticosteroids, and potentially antimalarials and…

A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled 12-Week Study to Evaluate the Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients with Primary Hypercholesterolemia or Mixed Dyslipidemia

To evaluate the efficacy and safety of extended release (ER) Niacin/Laropiprant when added to ongoing lipid-modifying therapy in patients with primary hypercholesterolemia or mixed dyslipidemia.

A Randomized, Open-Label, Phase 3 Study to Compare Long-Term Safety and Tolerability of
the TAK-491 and Chlorthalidone Fixed-Dose Combination Versus Olmesartan Medoxomil and
Hydrochlorothiazide Fixed-Dose Combination in Hypertensive Subjects With Moderate Renal
Impairment

The primary objective of this study is to evaluate the long-term safety and tolerability of the TAK-491CLD FDC in comparison to the OLM/HCTZ FDC in hypertensive subjects with moderate renal impairment.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study
Confirming the Efficacy and Safety of Genz-112638 in Patients with Gaucher
Disease Type 1

The primary objective of this study is to confirm the efficacy and safety of Genz 112638 after 39 weeks of treatment in patients with Gaucher disease type 1.The secondary objective of this study is to determine the long term efficacy, safety, and…

A Phase-3 Randomized, Double-Blind, Efficacy and Safety Study Evaluating the Fixed Dose
Combinations of TAK-491 Plus Chlorthalidone (40/12.5 mg and 40/25 mg) in Subjects With
Grades 2 or 3 Essential Hypertension, Who Do Not Achieve Target Blood Pressure
Following Treatment With TAK-491 40 mg Monotherapy.

The objective of this phase-3 randomized study, with a double-blind treatment period of 8 weeksduration is to evaluate the efficacy and safety of the fixed dose combinations of TAK-491 pluschlorthalidone (40/12.5 mg and 40/25 mg) in subjects with…

Feasibility, meachanism of action and potential side effects of extended release depot naltrexone (XRNT) in opioid dependent patients

The aims are: (1) to explore the feasibility of XRNT treatment in the Netherlands in terms of treatment participation and treatment retention; and (2) to study the mechanism of action of XRNT using pharmacoMRI and SPECT, and (3) to study the…