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NCT ID: NCT01132313 Completed - Clinical trials for Hepatitis C, Chronic

Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection

Start date: May 2010
Phase: Phase 2
Study type: Interventional

The substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating. The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerable adverse events in patients and in many cases are not sufficiently effective. This is particularly the case in treatment of patients infected with genotype 1 of HCV. A combination therapy of these new substances without pegylated interferon alfa may be associated with fewer adverse events that currently available (pegylated interferon-alfa-based) medication and may also provide a treatment option to the large number of patients with contraindications or intolerance to pegylated interferon alfa. This clinical trial (1241.21) currently consists of 3 distinct studies: Part 1, Part 2 and Part 3. Part 1 (SOUND-C1) is a 2 armed study as described in experimental arms 1 and 2 below (actual enrollment: 56 patients; randomized and treated: 32) Part 2 (SOUND-C2) is a 5 armed study as described in experimental arms 3 to 7 below (actual enrollment: 465; randomized and treated: 362) Part 3 (SOUND-C3) includes 3 arms as described in experimental arms 8 to 10 below (83 patients randomized and treated)

NCT ID: NCT01131676 Completed - Clinical trials for Diabetes Mellitus, Type 2

BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).

Start date: July 2010
Phase: Phase 3
Study type: Interventional

The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.

NCT ID: NCT01131624 Completed - Anaemia Clinical Trials

Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) Versus Oral Iron for Iron Deficiency Anaemia in Pregnant Women

ASAP
Start date: May 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to look at how well Ferric Carboxymaltose, an intravenous iron therapy (iron that is infused directly into your body through a vein), compares with ferrous sulphate capsules taken by mouth in the treatment of iron deficiency anaemia during pregnancy.

NCT ID: NCT01131000 Completed - Fever Clinical Trials

Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen in Adult Febrile Patients

Start date: June 2002
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of intravenous ibuprofen on reducing fever at 4 hours.

NCT ID: NCT01130844 Completed - Ulcerative Colitis Clinical Trials

Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis

Start date: October 8, 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine following administration in children and adolescents with ulcerative colitis.

NCT ID: NCT01130246 Terminated - Clinical trials for Acute Coronary Syndrome

VISTA-16 Trial: Evaluation of Safety and Efficacy of Short-term A-002 Treatment in Subjects With Acute Coronary Syndrome

VISTA-16
Start date: May 2010
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the safety and efficacy of short-term A-002 treatment on morbidity and mortality when added to atorvastatin and standard of care in subjects with an acute coronary syndrome (ACS).

NCT ID: NCT01129882 Completed - Schizophrenia Clinical Trials

An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Participants With Schizophrenia

ASPIRE
Start date: June 24, 2010
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to continue to provide aripiprazole intramuscular (IM) depot treatment (400 milligrams [mg] or 300 mg) to participants with schizophrenia completing the 52-week, open-label safety and tolerability Study 31-08-248. In addition, the secondary objective was to collect additional long-term safety data on aripiprazole IM depot treatment.

NCT ID: NCT01129661 Completed - Healthy Clinical Trials

Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers

Start date: June 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of escalating doses of CSL112 after single intravenous infusions in healthy volunteers and to measure the pharmacokinetics of CSL112 after single intravenous infusions in healthy volunteers.

NCT ID: NCT01128894 Completed - Diabetes Mellitus Clinical Trials

A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.

Start date: May 2010
Phase: Phase 3
Study type: Interventional

This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.

NCT ID: NCT01128868 Completed - Clinical trials for Reverse Oblique Subtrochanteric Fractures

Proximal Femur Locking Compression Plates Versus Trochanteric Nails

Start date: May 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the abductor muscle strength measured with a dynamometer in patients with reverse oblique inter- or subtrochanteric fractures treated either with a proximal femur locking plate or a trochanteric nail. "Proximal femur locking plates" stands for both the PF-LCP (Synthes) and the PeriLoc (Smith & Nephew). Trochanteric nails allowed in this study are the Proximal Femoral Nail Antirotation (PFNA), the Titanium Trochanteric Fixation Nail (TFN) and the Gamma Nail (GN).