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NCT ID: NCT01181128 Completed - Severe Hemophilia A Clinical Trials

Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A

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

The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical treatment regimen; to evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm 1); to evaluate the efficacy of rFVIIIFc administered as an on-demand (Arm 3) and surgical treatment regimen. The secondary objectives of this study are: to characterize the PK profile of rFVIIIFc and compare the PK of rFVIIIFc with the currently marketed product, Advate®; to characterize the range of dose and schedules required to adequately prevent bleeding in a prophylaxis regimen, maintain hemostasis in a surgical setting, or to treat bleeding episodes in an on-demand, weekly treatment, or prophylaxis setting.

NCT ID: NCT01180530 Completed - Diabetes Clinical Trials

Observational Study of NovoPen Echo® on Safety and Treatment Satisfaction in Children and Adolescents With Type 1 Diabetes

REMINDâ„¢
Start date: October 2010
Phase: N/A
Study type: Observational

This study is conducted in Asia, Europe and North America. The aim of this observational study is to evaluate the safety of NovoPen Echo® by collecting safety information (incidence of technical complaints related to adverse reactions). Study duration: 12-18 weeks.

NCT ID: NCT01180400 Completed - Depression Clinical Trials

A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder

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

The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

NCT ID: NCT01179178 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Dangerous Triad in Ageing and in Chronic Obstructive Pulmonary Disease (COPD) - Reduced Muscle Mass, Impaired Muscle Function and Malnutrition

Start date: March 2006
Phase: N/A
Study type: Observational

The investigators have taken part in the development of simple muscle function tests and studied physical training and energy turnover in patients with chronic obstructive pulmonary disease, COPD. The investigators have found that muscle wasting in COPD is related to poor prognosis and that physical training might lead to improved, less energy-demanding muscle function. Elderly subjects also suffer from muscle wasting that leads to frailty, poor autonomy and, secondarily, fractures. In the planned study the investigators will validate simple muscle function tests (hand grip strength, heel rise test, voluntary quadriceps muscle strength, 30 m walking test and balance tests) in both groups by relating them to an involuntary, magnet stimulated, test of quadriceps force, HRQL, tests of body composition (impedance, DXA) and recordings of physical activity. The relation between food intake, systemic inflammation, muscle mass and function will be analysed. The study has been ethically approved and started in COPD patients and will be expanded to a representative sample of elderly. Simple, evaluated muscle function tests applied in primary care may be used for early detection of muscle dysfunction in COPD patients and elderly so that early intervention against impaired muscle function can be started. Analyses of food intake and of inflammatory markers might identify factors of special importance for muscle dysfunction, which eventually might lead to improved dietary therapy and pharmacological interventions.

NCT ID: NCT01179048 Completed - Clinical trials for Diabetes Mellitus, Type 2

Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results

LEADER®
Start date: August 31, 2010
Phase: Phase 3
Study type: Interventional

This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes.

NCT ID: NCT01178281 Completed - Clinical trials for Primary Myelofibrosis

Study of Pomalidomide in Persons With Myeloproliferative-Neoplasm-Associated Myelofibrosis and RBC-Transfusion-Dependence

RESUME
Start date: September 8, 2010
Phase: Phase 3
Study type: Interventional

The objective of this study is to determine whether pomalidomide is safe and effective in reversing red blood cell (RBC)-transfusion-dependence in persons with myeloproliferative neoplasm (MPN)-associated myelofibrosis (global study) and in reversing anemia in Chinese with MPN-associated myelofibrosis and severe anemia not receiving RBC-transfusions (China extension study only)

NCT ID: NCT01178073 Completed - Clinical trials for Hypertension, Pulmonary

A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

AMBITION
Start date: October 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with Pulmonary Arterial Hypertension. This will be assessed by time to the first clinical failure event.

NCT ID: NCT01176682 Completed - Clinical trials for Rheumatoid Arthritis

Observational Study on Non-steroid Anti-inflammatory Drugs (NSAIDs) Treated Patients With Arthritic Disorder

EVIDENCE
Start date: August 2010
Phase: N/A
Study type: Observational

The aim of this study is to find out how patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis receiving NSAID-therapy are treated and managed by their doctor in usual clinical practice, how patients comply with their treatment and how satisfied they are with their treatment.

NCT ID: NCT01174446 Completed - Hemophilia B Clinical Trials

Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients

Start date: July 29, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this pivotal Phase 1/3 study is to determine the pharmacokinetic (PK) parameters, the hemostatic efficacy, and the safety of BAX 326, a recombinant factor IX, in previously treated patients (PTPs) with severe and moderately severe hemophilia B.

NCT ID: NCT01173471 Completed - Clinical trials for Raised Intraocular Pressure

A Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-ocular Pressure

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

The purpose of this study is to evaluate the efficacy of systemically administered AZD4017, compared with placebo, over a 28-day period in patients with raised intra-ocular pressure (IOP).