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NCT ID: NCT00385697 Completed - Clinical trials for Type 1 Diabetes Mellitus

The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

Start date: October 2006
Phase: Phase 2/Phase 3
Study type: Interventional

The primary purpose of this protocol is to assess the efficacy, tolerability, and safety of MGA031 when administered according to 3 different MGA031 dosing regimens in children and adults with recent-onset (diagnosis within past 12 weeks) type 1 diabetes mellitus. All regimens will be administered as an addition to insulin and other standard of care treatments. Efficacy will be defined primarily by the capacity of MGA031 to markedly reduce typical insulin requirements while maintaining relatively normal blood sugar levels. Other studies involving the study drug use the name hOKT3γ1 (Ala-Ala). MGA031, a humanized monoclonal antibody, is the name used for hOKT3γ1 (Ala-Ala) that is produced by MacroGenics, Inc. The United States Adopted Name (USAN) for MGA031 is teplizumab.

NCT ID: NCT00384774 Completed - Migraine Clinical Trials

A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine

Start date: November 2006
Phase: Phase 2
Study type: Interventional

This study evaluates the efficacy of a range of intravenous doses of COL-144 in the treatment of migraine headache in order to select a dose range for further studies.

NCT ID: NCT00384137 Completed - Transplantation Clinical Trials

A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney Recipients

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

Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable kidney transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive regimen.

NCT ID: NCT00383929 Completed - Hypertension Clinical Trials

Antihypertensive Efficacy and Safety of Candesartan/HCT 32/12.5 and 32/25 mg in Comparison With Candesartan 32 mg

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

In this study it is intended to compare the blood pressure lowering effect of the combination of candesartan cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg and the combination of candesartan 32 mg and HCT 12.5 mg to that of candesartan 32 mg alone in patients whose blood pressure is not well controlled on candesartan 32 mg monotherapy. The Primary Objectives are to compare sitting BP lowering effect of candesartan/HCT 32/25 mg and candesartan/HCT 32/12.5 mg with that of candesartan 32 mg, respectively.

NCT ID: NCT00383708 Completed - Acromegaly Clinical Trials

Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients

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

The main aim of this study is to assess the efficacy of the co-administration of lanreotide Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment period.

NCT ID: NCT00381953 Completed - Hepatitis C Clinical Trials

High-dose IFN and PEG IFN for Induction Therapy in Difficult to Treat Genotype 1 Patients With Chronic HCV

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

Comparison of virological breakthrough/relapse rate after dose adjustments and sustained virological response rate will be assessed by the type of induction.

NCT ID: NCT00380692 Completed - Clinical trials for Attention Deficit Disorder With Hyperactivity

Atomoxetine Versus Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents With Autism Spectrum Disorder

Start date: October 2006
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD (Attention Deficit/Hyperactivity Disorder) symptoms in children and adolescents with ASD (Autism Spectrum Disorder).

NCT ID: NCT00380302 Completed - Alzheimer Disease Clinical Trials

Activity of AVE1625 in Mild to Moderate Alzheimer's Patients.

Start date: September 2006
Phase: Phase 1/Phase 2
Study type: Interventional

Primary: This study is being conducted to evaluate if AVE1625 is safe and tolerated in patients with Alzheimer's disease that is not too severe. There is also evaluation of whether patients who take the study medication improve compared to patients who take a placebo (sugar pill). Secondary:The study will also evaluate the blood levels of the study medication, AVE1625 in patients who join the study.

NCT ID: NCT00379769 Completed - Clinical trials for Diabetes Mellitus, Type 2

RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes

RECORD
Start date: April 2001
Phase: Phase 3
Study type: Interventional

This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week run-in period will be followed by a median of 6 years of treatment with study medication in addition to continuation of background glucose lowering therapy. Patients inadequately controlled on background metformin will be randomised to receive, in addition to metformin, either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio of 1:1. Patients inadequately controlled on background SU will be randomised to receive, in addition to SU, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of patients receiving background metformin and SU at entry will be entered into the study.

NCT ID: NCT00378014 Completed - Clinical trials for Liver Transplantation

Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy

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

The study is designed to show that everolimus initiation together with reduction and thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal function in de novo liver transplant recipients as compared to continuation of CNI-based treatment.