21 results
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 16) in subjects with PAH.Secondary: To assess the effect of UT-15C SR…
The main objective of this study is to further determine the efficacy of lapaquistat acetate 50mg compared to placebo during a period of 12 weeks. This period is followed by an optional 48 week open label extension to be able to study the long term…
Evaluate the efficacy and safety of treatment with CNTO 95 in combination with docetaxel and prednisone compared with docetaxel and prednisone without CNTO 95 in subjects with metastatic HRPC.
To describe the safety and tolerability of up to 5 years denosumab administration as measured by adverse event monitoring, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab.
The question is whether aprepitant should be added to CE cycles (cisplatin containing regimen with etoposide) because of a possible interaction between aprepitant and etoposide.This question derives from the fact that both drugs are metabolised…
To establish the safety, tolerability, and early efficacy of multiple doses of hLF1-11 given once daily for 10 days
To establish the safety, tolerability, and early efficacy of multiple doses of hLF1-11 given once daily for 14 days.
Primary Objective for the Induction Phase* To determine the effect of MLN0002 induction treatment on clinical remission at 6 weeksPrimary Objective for the Maintenance Phase* To determine the effect of MLN0002 maintenance treatment on clinical…
To establish the safety and and tolerability and early efficacy of Alkaline phosphatase in the treatment of sepsis patients with renal failure.
Primary objective:* To assess the safety and tolerability of combined treatment with atacicept and rituximab insubjects with active rheumatoid arthritis receiving re-treatment with rituximab.Secondary objectives:* To evaluate the effect of combined…
To assess the efficacy of treatment with monochloroacetic compared to treatment with cryotherapy regarding patients with handwarts and compared to combination therapy (salicylic acid and cryotherapy) regarding patients with plantar warts.WARTS-1 has…
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…
The primary objective will be to assess the safety and tolerability of this combination and to determine whether the MTD ofEMD 521873 is reached up to a dose of 0.45 mg/kg. Secondary objectives will be the evaluation of the PK, immunogenicity,…
Primary objective:* To determine the safety, tolerability, dose-limiting toxicities (DLT), maximum acceptable dose (MAD) and maximum tolerated dose (MTD) of CHR-2845 when administered orally to patients with advanced or treatment refractory…
The objectives are to evaluate the safety and efficacy of TRC4186 and to define the recommended dose level for further pivotal studies.
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• Test the safety of the research drug, telcagepant (MK-0974)• Test the safety of the research study drug telcagepant (MK-0974) in the prevention of menstrually related migraines. • Compare the effectiveness of the research study drug telcagepant (…
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…
Primary:to examine the effect of co-administration with omeprazole on the pharmacokinetics of SSP-002358.Secondary:to provide additional safety information for SSP-002358 when administered alone or in combination with omeprazole.
The primary objective of the study is to compare the efficacy of intravenous immunoglobulin product with the efficacy of antibiotic treatment in patients with recurrent respiratory infections and IgG-subclass deficiency and/or selective anti-…