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NCT ID: NCT00993473 Completed - Clinical trials for Type 1 Diabetes Mellitus

6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes

PRESCHOOL
Start date: October 2009
Phase: Phase 3
Study type: Interventional

The primary study objective was to compare the rate of "all hypoglycemia" (composite outcome of the following hypoglycemia events: symptomatic hypoglycemia episodes, low continuous glucose monitoring system (CGMS) excursions confirmed by fingerstick blood glucose (FSBG), low FSBG readings performed at other times) between children treated with Lantus (insulin glargine) and Neutral Protamine Hagedorn (NPH) insulin. Secondary objectives were to compare insulin glargine and NPH in terms of: - rates of specific types of hypoglycemia: symptomatic, severe, nocturnal, nocturnal symptomatic, and severe nocturnal symptomatic hypoglycemia - HbA1c change from baseline to end-of-treatment, and HbA1c at end-of-treatment - percentage of patients reaching HbA1c less than 7.5% (target value) at end of treatment - average blood glucose over whole trial and at end of trial, as estimated by continuous glucose monitoring (CGM), and blood glucose variability

NCT ID: NCT00993382 Completed - Clinical trials for Ventricular Arrhythmia

Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death

ALPHEE
Start date: September 2009
Phase: Phase 2
Study type: Interventional

The Primary Objective was to assess the efficacy of celivarone for the prevention of Implantable Cardioverter Defibrillator (ICD) interventions or death. Secondary Objectives were: - To assess the tolerability and safety of the different dose regimens of celivarone in the selected population. - To document SSR149744 plasma levels during the study.

NCT ID: NCT00986154 Completed - Clinical trials for Venous Thromboembolism

Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).

Start date: October 2009
Phase: Phase 3
Study type: Interventional

Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.

NCT ID: NCT00985491 Active, not recruiting - Obesity Clinical Trials

Study for Short Term Weight Loss in Candidates for Bariatric Surgery

Start date: October 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether the GI Endobarrier Liner is safe and effective.

NCT ID: NCT00979654 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Subjects With Systemic Lupus Erythematosus or Myositis

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

The objective of this study is to assess the safety and tolerability of sifalimumab in adult subjects with active systemic Lupus Erythematosus (SLE) or active dermatomyositis (DM) or polymyositis (PM) who participated in the following clinical studies: MI-CP151, MI-CP152, or MICP179.

NCT ID: NCT00976937 Completed - Clinical trials for Type 2 Diabetes Mellitus

24-week Study Comparing Lixisenatide to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 Years

Start date: August 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate benefits and risks of lixisenatide (AVE0010), in comparison to sitagliptin, as an add-on treatment to metformin, in obese (body mass index [BMI] greater than or equal to 30 kilogram per square meter [kg/m^2]) type 2 diabetic patients less than 50 years of age, over a period of 24 weeks of treatment. The primary objective of this study is to assess the efficacy of lixisenatide, in comparison to sitagliptin, as an add-on treatment to metformin on a composite endpoint of glycemic control in terms of glycosylated hemoglobin (HbA1c) and body weight, at Week 24. Secondary objectives are to assess the effects of lixisenatide, in comparison to sitagliptin, as an add-on treatment to metformin on absolute changes in HbA1c values and body weight; fasting plasma glucose (FPG); plasma glucose, insulin, C-peptide, glucagon, and proinsulin during a 2-hour standardized meal test; insulin resistance assessed by homeostatic model assessment of insulin resistance (HOMA-IR); beta cell function assessed by homeostatic model assessment of beta-cell function (HOMA-beta); to evaluate safety, tolerability, and anti-lixisenatide antibody development.

NCT ID: NCT00975312 Completed - Lentigo Clinical Trials

Solar Lentigines Treatment With the Triple Combination Cream

Start date: August 2008
Phase: Phase 2
Study type: Interventional

Background - Lentigines are usually the first sign of photoaging and may produce a significant impact on patients' quality of life. - There is no a treatment of choice for this condition. - Solar lentigines and melasma share similar physiopathologic characteristics. - The triple combination (TC) cream (hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01%) has been effective and safe for the treatment of melasma and other hyperpigmented lesions. Hypothesis * The TC cream will be effective and safe for the treatment of solar lentigines on the back of the hands. Patients and methods - 22 patients with solar lentigines were selected and their right hand or left hand were selected at random to be treated with either TC cream or tretinoin 0.05% cream once daily for up 12 weeks. - Patients were instructed to apply both creams on the whole back of the hand and not only in the lentigines, and to use a broad-spectrum sunscreen (SPF 50+, UVA-PF 28) daily in both hands. - Clinical assessments of Target Lesion Pigmentation, Physician's Global Assessment of Improvement and a Subject's Self-Assessment questionnaire were collected for data analysis at weeks 4, 8, and 12 after starting the treatment and 3 month post-treatment. - Statistical methods: The ordinally scaled efficacy measures underwent rank transformation and were analyzed by analysis of variance to test the null hypothesis of no differences among treatments. We performed Mann-Whitney and Wilcoxon tests and the XLSTAT 2009 software was used.

NCT ID: NCT00975286 Completed - Clinical trials for Type 2 Diabetes Mellitus

24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine

GetGoal Duo1
Start date: October 2009
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment. The primary objective is to assess the effects of lixisenatide in comparison to placebo, when added to insulin glargine and metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on the percentage of patients reaching HbA1c less than (<) 7 percent (%) and less than or equal to (<=) 6.5%, plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability (including anti-lixisenatide antibody assessment), and to assess the impact on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated.

NCT ID: NCT00974311 Completed - Clinical trials for Castration-Resistant Prostate Cancer

Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy

AFFIRM
Start date: September 30, 2009
Phase: Phase 3
Study type: Interventional

This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.

NCT ID: NCT00973960 Completed - Type 2 Diabetes Clinical Trials

A Pilot Trial of the EndoBarrierâ„¢ Flow Restrictor for Glycemic Improvement in Type 2 Diabetics

Start date: September 2009
Phase: N/A
Study type: Observational

The main objective of the study is to demonstrate the safety and efficacy of the EndoBarrier Flow Restrictor in the glycemic control of diabetes in subjects with Type 2 diabetes. The primary efficacy endpoint is an assessment of glycemic control at week 24 or last assessment measured via HbA1c.