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NCT ID: NCT00781391 Completed - Stroke Clinical Trials

Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation

EngageAFTIMI48
Start date: November 2008
Phase: Phase 3
Study type: Interventional

This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, & Warfarin. The expected duration of the study is 24 months.

NCT ID: NCT00774397 Completed - Clinical trials for Hepatitis C, Chronic

Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)

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

The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated interferon α-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed in treatment-naïve (TN) and treatment experienced (TE) patients.

NCT ID: NCT00774345 Completed - Clinical trials for B-cell Chronic Lymphocytic Leukemia

A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line Therapy

Start date: January 27, 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if lenalidomide (Revlimid®) is safe and effective as a maintenance therapy at improving further the quality of the response you achieved with your last therapy and at prolonging the duration of your response. This study will compare the effects (good and bad) of lenalidomide with the dummy drug.

NCT ID: NCT00763802 Completed - Clinical trials for Diabetic Retinopathy

Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema and/or Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2

CPM
Start date: September 2007
Phase: N/A
Study type: Observational

This project aims to validate a predictive model of diabetic retinopathy progression to clinically significant macular edema (CSME) needing photocoagulation and/or vision loss. The Coimbra Predictive Model (CPM), based on retinal thickness, microaneurysms number, HbA1C and LDL levels, established on a set of 52 diabetic patients, will be tested on a population of 400 patients/eyes to be enrolled into the study. These patients will perform 2 visits at 6-month interval (V0 and V6) to classify each patient into one of the 3 previously established phenotypes. Two years after (V24) patients will be reexamined. The occurrence of end-points, achieved by the patients, are expected to validate our predictive model.

NCT ID: NCT00759044 Completed - Clinical trials for Diabetic Macular Edema

Validation of a New Methodology for Mapping the Human Blood-Retinal Barrier Function

Start date: March 2008
Phase: N/A
Study type: Observational

To validate a new methodology, named Retinal Leakage Analysis (RLA), for mapping the human Blood-Retinal Barrier (BRB) function, in the clinical practice.

NCT ID: NCT00758849 Not yet recruiting - Parkinson's Disease Clinical Trials

Fipamezole in Neurogenic Orthostatic Hypotension

Foehn
Start date: September 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether Fipamezole is effective in the treatment of orthostatic hypotension and related symptoms in multiple system atrophy and Parkinson's disease.

NCT ID: NCT00757731 Completed - Clinical trials for Fibromyalgia Syndrome

FMS European Long-Term Study

Start date: September 2006
Phase: Phase 3
Study type: Interventional

Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the treatment of fibromyalgia syndrome.

NCT ID: NCT00757237 Completed - Cystic Fibrosis Clinical Trials

Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa

Start date: August 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study was to assess the comparative safety and effectiveness of aztreonam for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection.

NCT ID: NCT00755287 Completed - Clinical trials for Diabetes Mellitus Type 2

A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.

Start date: November 2008
Phase: Phase 3
Study type: Interventional

This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years, and the target sample size if 500+ individuals.

NCT ID: NCT00751114 Completed - Clinical trials for Diabetes Mellitus, Type 2

Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients

EASIE
Start date: November 2008
Phase: Phase 4
Study type: Interventional

The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period. Secondary objective was to assess the effect of insulin glargine in comparison with sitagliptin on: - HbA1c level - Fasting Plasma Glucose (FPG) - 7-point plasma glucose (PG) profiles - Percentage of patients with HbA1c <7% and <6.5% Safety objectives consisted of: - Hypoglycemia occurrence - Body weight - Overall safety