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Showing 10621-10640 of 13,060 trials
NCT01424696
Cystic fibrosis (CF) is a life-shortening disease that causes breathing and digestive problems, but can now be diagnosed at the time of birth. Lung function is very hard to measure in infants, but growth is not. In this study the investigators aim to define growth in infants with CF in the first year of life with research quality precision and to understand factors that interfere with good growth. Pancreatic enzyme replacement therapy (PERT) will be also be studied in a subgroup of infants. Two different doses of PERT will be evaluated for improving fat and nitrogen absorption in infants with CF.
NCT02504463
This study will determine the pharmacokinetics (PK) of \[14c\]-samidorphan in healthy male volunteers.
NCT00984620
To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1
NCT01221636
The purpose of this study is to determine whether the blood levels of abatacept drug product manufactured using High Metals and using Low Metals are comparable in healthy subjects.
NCT00298272
The primary objective of this study was to evaluate the tolerability and safety of rituximab in combination with methotrexate (MTX) and etanercept or adalimumab in participants with active rheumatoid arthritis (RA). The secondary objective was to explore the efficacy of rituximab in combination with MTX and etanercept or adalimumab in participants with active RA.
NCT01873404
The primary objective of the study is to assess the efficacy of Intravenous (IV) BG00010 (Neublastin) in improving pain in painful lumbar radiculopathy participants when administered 3 times per week for 1 week. The secondary objectives of this study in this study population are as follows: To explore the duration of the effect of BG00010 in improving pain; To explore the dose response curve on pain reduction; To assess the safety and tolerability of BG00010; To assess the serum exposure to BG00010.
NCT00498914
A study in subjects with a type of B cell lymphoma (DLBCL)to evaluate the response rate, efficacy, safety and tolerability of YM155
NCT01908595
This study is to evaluate the efficacy and safety for long term use of M518101 in subjects with plaque psoriasis.
NCT01496469
The purpose of this study is to evaluate the effect of febuxostat, once daily (QD), compared to placebo on lowering ambulatory 24-hour mean blood pressure of participants with hypertension and hyperuricemia (not associated with gout).
NCT00659893
Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas.
NCT00796289
The primary objective of this study is to determine the safety and efficacy of pulsatile GnRH delivered from a iontophoretic patch (Lutrepatch) for induction of ovulation in women with anovulatory/ oligoovulatory infertility, compared to placebo and to a reference treatment with clomiphene citrate.
NCT00729664
Collection of survival data, evaluation of PDL-1 expression in tumors, and evaluation of PD-L1 receptor occupancy in peripheral blood has been added.
NCT01730040
This is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH).
NCT00953706
The purpose of this study was to evaluate the safety and efficacy of ivacaftor in participants with cystic fibrosis (CF) who were aged 12 years or older and were homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic adenosine monophosphate (AMP)-dependent protein kinase A (PKA) activation.
NCT00042458
This is a randomized, triple-blind, placebo-controlled, multicenter study to investigate the safety of pramlintide treatment using pramlintide dose-titration coupled with insulin adjustments in subjects with type 1 diabetes who are actively trying to improve their glycemic control.
NCT01369615
The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy who completed the 4 -week treatment period in OTR3001.
NCT00057564
To compare the efficacy of combination oral thalidomide plus oral dexamethasone treatment to that of oral dexamethasone-alone treatments as induction (first-line) therapy for subjects with active multiple myeloma
NCT00135577
Study SB-767905/008 was a multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in participants with cancer pain. Study ABD101684 will serve as an extension to Study SB-767905/008 and offer continued access to blinded investigational product to participants who have completed the original study. The purpose of Study ABD101684 is to evaluate the safety and efficacy of alvimopan compared to placebo in subjects who completed Study SB-767905/008 and elected to participate in this extension study.
NCT00159224
This study will assess the safety, tolerability and antiviral activity of a simplified PI-based treatment regimen (Kaletra,ä) compared to conventional HAART regimens in patients infected with HIV-1 who are on their first boosted-PI antiretroviral treatment regimen. The potency of the antiviral activity of Kaletra has been clearly demonstrated in a wide spectrum of patients in a number of different clinical trials.6-9 The durable viral suppression seen after 4 years of therapy10 proves that it can provide effective, long-term treatment for people with HIV-1. Data from one of these trials (M97-720),6 an ongoing Phase II study of lopinavir/ritonavir in combination with NRTIs suggests there may be a role for monoclass therapy with Kaletra in the treatment of HIV-1-infection.
NCT01288469
Primary Objective: To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of atorvastatin after 8 weeks of treatment in participants with LDL-C ≥ 100mg/dL (≥ 2.59 mmol/L) on atorvastatin 10 mg. Secondary Objectives: * To evaluate the effects of alirocumab on other lipid levels in comparison with placebo, when co-administered with 80 mg of atorvastatin after 8 weeks of treatment. * To evaluate the efficacy of alirocumab when co-administered with a high dose of atorvastatin (80 mg) versus atorvastatin 10 mg. * To evaluate the safety and tolerability of alirocumab when co-administered with 2 different doses of atorvastatin. * To evaluate the development of anti-alirocumab antibodies. * To evaluate the pharmacokinetics of alirocumab.
