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NCT ID: NCT00191932 Completed - Clinical trials for Major Depressive Disorder

Switching to Duloxetine From Other Antidepressants

Start date: August 2004
Phase: Phase 4
Study type: Interventional

A multicentre, randomised, open label study of out-patients with major depression who have failed to respond adequately to antidepressant treatment for their current episode of depression. The study compares outcomes associated with two methods of switching from current antidepressant to duloxetine

NCT ID: NCT00189839 Completed - Clinical trials for Kidney Transplantation

A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney Transplantation

Start date: August 2004
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate and to compare the efficacy and safety of a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

NCT ID: NCT00189826 Completed - Clinical trials for Liver Transplantation

A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Liver Transplantation.

Start date: August 2004
Phase: Phase 3
Study type: Interventional

To evaluate and to compare efficacy and safety of a dual regimen with oral modified release tacrolimus FK506E (MR4) / steroids versus a dual regimen with oral tacrolimus FK506 / steroids in patients undergoing primary liver transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

NCT ID: NCT00185198 Completed - Male Clinical Trials

Efficacy and Safety of Testogel® in Men With Partial Androgen Deficiency of Aging Males (PADAM)

Start date: September 2004
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effect of a testosterone replacement therapy called Testogel in men with PADAM. The effects on body composition (lean, fat and bone) and other symptoms of PADAM and safety will be studied.

NCT ID: NCT00184600 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparison of Insulin Detemir, Insulin Aspart and Biphasic Insulin Aspart 30 With OAD Treatment in Type 2 Diabetes

4T
Start date: November 2004
Phase: Phase 3
Study type: Interventional

This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added to current OAD (oral anti-diabetic drug) treatment in subjects with type 2 diabetes and to verify the safety of use (number and severity of episodes of hypoglycaemia, body weight and side effects).

NCT ID: NCT00182715 Active, not recruiting - Colorectal Cancer Clinical Trials

Combination Chemotherapy With or Without Cetuximab as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

Start date: March 2005
Phase: Phase 3
Study type: Interventional

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy and cetuximab are more effective than combination chemotherapy alone in treating colorectal cancer. PURPOSE: This randomized phase III trial is studying combination chemotherapy and cetuximab to see how well they work compared to combination chemotherapy alone as first-line therapy in treating patients with metastatic colorectal cancer.

NCT ID: NCT00175903 Completed - Epilepsy Clinical Trials

Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy

Start date: February 2005
Phase: Phase 3
Study type: Interventional

Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with newly diagnosed epilepsy.

NCT ID: NCT00174655 Completed - Breast Neoplasms Clinical Trials

BIG 02/98 Docetaxel - Breast Cancer

Start date: June 1998
Phase: Phase 3
Study type: Interventional

Primary objectives: - To compare Disease-Free Survival (DFS) of an adjuvant treatment with docetaxel given either sequentially or in combination with doxorubicin and followed by CMF to doxorubicin alone or in combination with cyclophosphamide and followed by CMF in operable breast cancer patients with positive axillary lymph nodes. Secondary objectives: - To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin followed by CMF in operable breast cancer patients with positive axillary lymph nodes - To compare DFS of an adjuvant treatment with docetaxel in combination with doxorubicin followed by CMF to doxorubicin in combination with cyclophosphamide followed by CMF in operable breast cancer patients with positive axillary lymph nodes - To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin in combination with docetaxel followed by CMF in operable breast cancer patients with positive axillary lymph nodes, (sequential mono-chemotherapy versus polychemotherapy). - To compare overall survival of treatment arms. - To compare toxicity of treatment arms. - To evaluate pathologic and molecular markers for predicting efficacy. - Socioeconomic data will be collected in order to be able to perform a socioeconomic analysis by country, when needed.

NCT ID: NCT00174642 Completed - Clinical trials for Diabetes Mellitus, Type 2

Opposing Step-by-step Insulin Reinforcement to Intensified Strategy

OSIRIS
Start date: December 2004
Phase: Phase 3
Study type: Interventional

Primary objectives : - To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin combined with 3 bolus of insulin glulisine (Arm 1), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs. - To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin and insulin secretagogue (sulfonylurea or glinide) combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 3), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs. Secondary objectives : - To compare between the 3 treatment groups: evolution of HbA1c over time, percentage of subjects with HbA1c <= 7% at the end of the study, evolution of blood glucose profiles, incidence of hypoglycemia, insulin doses, evolution of body weight and treatment satisfaction.

NCT ID: NCT00174304 Completed - Hypertension Clinical Trials

Open Label Study To Assess The Effectiveness Of Amlodipine-Atorvastatin Combination In Hypertension And Dyslipidemia.

JEWEL II
Start date: October 2004
Phase: Phase 4
Study type: Interventional

To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing the percentage of subjects who reach target blood pressure (BP) and LDL-C targets as defined by their governing guidelines.