38 results
The primary objective of this study is to compare the progression free survival (PFS) following administration of IPI-504 plus best supportive care versus placebo plus best supportive care in patients with metastatic and/or unresectable…
A clinical research study to find out if Xolair is safe and has beneficial effects in adolescents (12 years old and above) and adults with cystic fibrosis (CF) and ABPA. All patients entering the study will be taking oral corticosteroids (steroid…
To assess the efficacy of bosentan in neonates with persistent pulmonary hypertension of the newborn (PPHN) who are in need of continued inhaled nitric oxide (iNO) after at least 4 hours of continuous iNO treatment and to evaluate the…
Part 1:- To assess tolerability, safety and PK of escalating single Intravenous (IV) doses of NI-0101 in healthy volunteers with the aim of covering a wide range of plasma concentrations up to those theoretically reflecting a potential therapeutic…
The objective of this study is to evaluate the efficacy and safety of adalimumab 80 mg loading dose followed by 40 mg dose given every other week (eow) subcutaneously (SC) starting at Week 1 compared with placebo in subjects with inactive non-…
Primary Study Objective:To assess the efficacy and safety of the co-administration of low-dose pegvisomant (40 mg, administered via subcutaneous injection given once a week) and long-acting somatostatin analogs (administered once monthly) on the…
The objective of this study is to evaluate the efficacy and safety of adalimumab 80 mg loading dose followed by 40 mg dose given every other week (eow) subcutaneously (SC) starting at Week 1 compared with placebo as maintenance therapy in subjects…
Investigate the effect of adjuvant metformin therapy on insulin need and on glycaemic control in CFRD patients.
To investigate the effect of low-dose long acting insulin therapy on nutritional status in adult CF patients without diabetes.
Primary: treatment effect of BKM120 once daily plus weekly paclitaxel versus BKM120 matching placebo once daily plus weekly paclitaxel on progression-free survival for each of the two groups, namely 1) PI3K pathway activated patients and 2) full…
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…
The primary objective is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in subjects receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the subject that best…
The primary objective of this study is to determine the clinical safety and efficacy of adalimumab compared to placebo in subjects with moderate to severe HS after 12 weeks of treatment. A secondary objective is to evaluate safety and explore…
The primary objectives of this study are to compare the percentage of subjects achieving SVR12 (HCV RNA < lower limit of quantification [LLOQ] 12 weeks following treatment) of 12 weeks of treatment with ABT-450/r/ABT-267 and ABT-333 co-…
Primary ObjectiveTo assess the effect of ABT-981 on OA knee pain using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 16 and synovitis/effusion volume of the index knee using quantitative measures and semi-…
The objectives of the study are as follows:*1. To assess the effectiveness of inhaled PA101 delivered via eFlow high efficiency nebulizer for treating chronic cough. Improvements in chronic cough will be assessed by measuring the change from…
Primary Objective: The main objective of this study is to identify a new treatment to alleviate pain and diminish inflammation in patients with hand osteoarthritis with symptoms and signs of inflammation.Secondary Objectives: The secondary…
Primary:To establish the safety and tolerability of rivastigmine when given with concomitant glycopyrrolate at an accelerated dose escalation schedule up to 12 mg BID.To establish the safety and tolerability of rivastigmine when given with…
Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (unkown status…
The primary objective of the study is to evaluate the percentage of subjects who do not experience a flare on CZP 200mg Q2W (full-dose) or 200mg Q4W (half-dose) during Part B. The secondary objectives are: 1) to evaluate the percentage of subjects…