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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: NCT00174993 Completed - Diabetes Mellitus Clinical Trials

Efficacy of Pioglitazone on Macrovascular Outcome in Patients With Type 2 Diabetes

PROactive
Start date: May 2001
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether pioglitazone, once daily (QD), can delay the time to death, heart attack, acute coronary syndrome, heart bypass surgery, stroke, leg bypass surgery or amputation in patients with type 2 diabetes.

NCT ID: NCT00174863 Completed - Prostatic Neoplasm Clinical Trials

Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate Cancer

ODYSSEY
Start date: October 2003
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy of SR31747 given at 75 or 125mg per day versus placebo in androgen prostate cancer patient without distant metastases with Time to Clinical progression as main objective and PSA parameters, Tumor response, survival , safety,Tumor-related symptoms deterioration Quality of Life, PK analysis as secondary objectives

NCT ID: NCT00174785 Completed - Atrial Fibrillation Clinical Trials

A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation

ATHENA
Start date: June 2005
Phase: Phase 3
Study type: Interventional

To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter (AF/AFL). To assess that dronedarone is well tolerated in this population.

NCT ID: NCT00174772 Completed - Lung Neoplasms Clinical Trials

Pulmonart: Docetaxel - Non-Small Cell Lung Cancer (NSCLC)

Start date: March 2004
Phase: Phase 2
Study type: Interventional

Primary Objective: - To evaluate the toxicity/safety profile of docetaxel/cisplatin induction therapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy followed by consolidation docetaxel/cisplatin in patients with locally advanced unresectable NSCLC (stage IIIA- multiple cN2 or IIIB). Secondary Objective: - To estimate efficacy parameters in overall response rate, progression free survival and 1 year survival for each of the two above mentioned arms.

NCT ID: NCT00174759 Completed - Clinical trials for Arterial Occlusive Diseases

CASPAR : Clopidogrel and Acetyl Salicylic Acid in Bypass Surgery for Peripheral ARterial Disease

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

Primary objective: To evaluate whether clopidogrel 75 mg o.d. versus placebo (on a background of ASA 75-100 mg/d) will lead to an increased rate of primary patency, limb salvage and survival, in patients receiving a below knee bypass graft for the treatment of PAD. Secondary objectives: Comparison, between the two treatment groups, of : - Primary patency, - Assisted primary patency, - Cardiovascular death / myocardial infarction / stroke / any amputation above the ankle. - Ankle Brachial Pressure Index (ABPI) changes from baseline

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: 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: NCT00174616 Completed - Rectal Neoplasms Clinical Trials

CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision

Start date: July 2003
Phase: Phase 2
Study type: Interventional

Primary objective: - Pathological complete response (ypT0N0) rate Secondary objectives: - Histopathological R0 resection rate - Pathological downstaging (ypT0-T2N0) rate - One month surgical complication rate - Predictive value of pre-operative MRI for surgical, pathological and clinical outcomes - Safety - Local and distant recurrence rates - Progression-free survival - Overall survival

NCT ID: NCT00172185 Completed - Clinical trials for Short Bowel Syndrome

Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

Start date: January 10, 2005
Phase: Phase 3
Study type: Interventional

The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.