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NCT ID: NCT01032629 Completed - Clinical trials for Diabetes Mellitus, Type 2

CANVAS - CANagliflozin cardioVascular Assessment Study

CANVAS
Start date: December 9, 2009
Phase: Phase 3
Study type: Interventional

The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events (MACE). Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin. The data from this study will be combined with the data from CANVAS-R study (Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing requirements for canagliflozin.

NCT ID: NCT01032239 Completed - Severe Spasticity Clinical Trials

SISTERS: Spasticity In Stroke Study - Randomized Study

SISTERS
Start date: November 2009
Phase: Phase 4
Study type: Interventional

To demonstrate that Intrathecal Baclofen (ITB) Therapy, compared to Best Medical Treatment (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke patients with generalized spastic hypertonia who have not reached their therapy goal with other treatment interventions assessed by a decrease in the average Ashworth Scale (AS) score in the lower extremities.

NCT ID: NCT01031680 Completed - Hypertension Clinical Trials

Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension

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

This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight and blood pressure, when added to patients existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes, cardiovascular disease and hypertension.

NCT ID: NCT01030523 Completed - Clinical trials for Jaw, Edentulous, Partially

Short Implants - An Alternative to Bone Grafting?

Start date: October 2009
Phase: N/A
Study type: Interventional

The study, with the ASTRA TECH Implant System, is comparing short implants (OsseoSpeed™) to standard length implants (OsseoSpeed™) in combination with bone grafting. The hypothesis is that the use of short implants in posterior maxilla with inadequate bone is as safe and predictable as placing standard length implants in combination with bone augmentation.

NCT ID: NCT01030432 Completed - Hepatitis C Virus Clinical Trials

Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

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

The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).

NCT ID: NCT01030185 Completed - Ascites Clinical Trials

Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance

PIONEER
Start date: February 2010
Phase: Phase 2/Phase 3
Study type: Interventional

To investigate the safety and performance of the Automated Fluid Shunt in patients with ascites and diuretic resistance. Study Size and Duration The primary study population will include 40 patients enrolled and implanted with the NovaShunt Automated Fluid Shunt (AFS) in up to 15 centers in Europe.

NCT ID: NCT01029886 Completed - Clinical trials for Type 2 Diabetes Mellitus

Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes

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

No head to head comparisons between exenatide once weekly and liraglutide have been performed. Therefore, the purpose of this study is to compare exenatide once weekly to once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and other clinical benefits. The study includes a 26-week treatment period and a safety follow-up visit 10 weeks after the final study drug dose.

NCT ID: NCT01029340 Completed - Hemophilia A Clinical Trials

Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A

Leopold I
Start date: December 2009
Phase: Phase 3
Study type: Interventional

The study will assess the pharmacokinetics (part A) safety, tolerability, and efficacy of prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period (split into two six month treatment periods). The study will compare 2 different methods (assays) for measuring the amount of study drug, the chromogenic substrate assay per European Pharmacopeia (CS/EP) with the classical assay (Chromogenic Substrate Adjusted, CS/ADJ). During one six month period patients will receive the study drug where the dose has been measured using the" (CS/EP) and during the other six months period the dose will be measured based on the Chromogenic Substrate Adjusted assay CS/ADJ)

NCT ID: NCT01029262 Completed - Anemia Clinical Trials

A Study of Lenalidomide Versus Placebo in Subjects With Transfusion Dependent Anemia in Lower Risk Myelodysplastic Syndrome (MDS) Without Del 5q

MDS-005
Start date: January 26, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate whether lenalidomide would reduce the number of red blood cell transfusions (RBC) needed in anemic (RBC transfusion-dependent) participants with low or intermediate-1 risk MDS without a deletion 5q chromosome abnormality. The study also investigated the safety of lenalidomide use in these participants. Two-thirds of the participants received oral lenalidomide and one-third of the participants received oral placebo.

NCT ID: NCT01028222 Completed - Melanoma Clinical Trials

A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation

TEAM
Start date: June 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether nilotinib is efficacious in the treatment of metastatic and/or inoperable melanoma harboring a c-Kit mutation.