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NCT ID: NCT00174668 Completed - Clinical trials for Diabetes Mellitus, Type 2

Insulin Glulisine in Diabetes Mellitus, Type 2

GINGER
Start date: November 2004
Phase: Phase 3
Study type: Interventional

Primary objective: The primary study objective is to demonstrate superior efficacy of an intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of change in glycated hemoglobin A1c (HbA1c), from baseline to endpoint. Secondary objectives: Secondary study objectives are to compare the intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of blood glucose (BG) values (fasting, pre-/postprandial (ppBG), nocturnal, mean daily, fasting plasma glucose), daily BG profiles, BG and HbA1c response rates (predefined), hypoglycemic events, adverse events, change of late diabetes complications, weight, body-mass-index, course of total daily insulin dose and adjustment, blood lipid profile, microalbuminuria, standard lab and quality of life/treatment satisfaction.

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: NCT00170950 Terminated - Hypertension Clinical Trials

Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension

ACCOMPLISH
Start date: October 2003
Phase: Phase 3
Study type: Interventional

A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population.

NCT ID: NCT00168844 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Tiotropium / Respimat One-Year Study

Start date: January 2003
Phase: Phase 3
Study type: Interventional

To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.

NCT ID: NCT00168818 Completed - Thromboembolism Clinical Trials

Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery

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

The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.

NCT ID: NCT00168805 Completed - Clinical trials for Arthroplasty, Replacement, Knee

RE-MODEL Dabigatran Etexilate 150mg or 220mg Once Daily (o.d.) Versus (v.s.) Enoxaparin 40mg o.d. for Prevention of Thrombosis After Knee Surgery

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

A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)

NCT ID: NCT00168766 Completed - Clinical trials for Relapsing-remitting Multiple Sclerosis

Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MS

Start date: January 2003
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to determine whether combination treatment (adding methylprednisolone to Avonex) reduces progression of disability over 4 years compared to Avonex alone. The study will also investigate whether combination therapy has any impact on the incidence of relapse and brain atrophy as measured by MRI.

NCT ID: NCT00168701 Completed - Multiple Sclerosis Clinical Trials

Efficacy and Safety of BG00012 in MS

Start date: October 1, 2004
Phase: Phase 2
Study type: Interventional

Determine the efficacy, safety, and tolerability of BG00012 in MS patients.

NCT ID: NCT00168480 Completed - Hyperhidrosis Clinical Trials

A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis

Start date: November 2003
Phase: Phase 4
Study type: Interventional

This is a three year open-label study in subjects with axillary hyperhidrosis.