116 results
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…
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.
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.
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…
Primary objective• To demonstrate that either dose of ACT-064992 prolongs the time to the first morbidity or mortality event in patients with symptomatic pulmonary arterial hypertension.Secondary objectives• To demonstrate that either dose of ACT-…
The primary objective is to evaluate the efficacy of i) a prime-and-boost regimen with 20 µg Diamyd and ii) a prime-and-boost regimen with 20 µg Diamyd, followed by 2 additional single doses with 20 µg Diamyd, compared to placebo with respect…
To compare visual outcome and foveal function after (initiation of) treatment between patients receiving an RPE-choroid graft and patients with anti-VEGF medication.
The primary objective is to demonstrate superiority in overall survival of amrubicin (40 mg/m2 administered as a 5-minute infusion once daily for 3 consecutive days starting on Day 1 of a 21-day course) compared with topotecan hydrochloride (…
The objective of the study is to compare the efficacy and tolerability of mesalazine granules (3 g 5*ASA/d) vs. placebo for the prevention of recurrence of diverticulitis. Additionally, the safety and tolerability in the form of adverse events and…
This study will be conducted in two parts as described below:Part 1 will include subjects who participated in a Phase 1, 2, or 3 clinical study in which boceprevir was administered.Part 2 will include subjects who participated in a Phase 1, 2, or 3…
To evaluate PFS with XL184 treatment as compared with placebo in subjects with unresectable, locally advanced, or metastatic MTC to see if the investigational drug XL184 is effective in delaying the growth of the tumor.
The objectives of this open-label study are to evaluate the efficacy (GL-3 clearance), pharmacokinetics (PK), and safety parameters (including immunogenicity) for 2 alternative dose regimens of Fabrazyme (0.5 mg/kg every 2 weeks [q2w] and 1.0 mg/kg…
BAY 63 2521 is a direct 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 the treatment of…
The primary objective of this study is to assess the comparative safety and efficacy ofAztreonam Lysine for Inhalation (AZLI) and Tobramycin Nebuliser Solution (TNS) in adultand pediatric cystic fibrosis (CF) patients aged 6 years or older with…
to investigate in a descriptive way the dose-dependent effect of Olmesartan Medoxomil 20mg, 40mg en 80mg on arterial stiffness.
- To assess the safety and tolerability of a nonadjuvanted H5N1 influenza vaccine in an adult and elderly population and in specified risk groups;- To assess the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult and…
To evaluate the efficacy of Lanreotide Autogel 120 mg when used as primary medical treatment in untreated de novo acromegalic patients with macroadenoma
Primary Objective: The primary objective is to evaluate the efficacy of 2 doses ofperampanel (8 and 12 mg) in comparison to placebo given as an adjunctive therapy insubjects with refractory partial seizures.Secondary Objective: The secondary…
This randomized phase III study is designed to investigate whether PCI could reduce the incidence of brain metastases or delay their appearance in patients with stage III NSCLC who are treated with curative intention.
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…