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NCT ID: NCT00196716 Completed - Fabry Disease Clinical Trials

A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease

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

People with Fabry disease have an alteration in their genetic material (DNA) which causes a deficiency of the alpha-galactosidase A enzyme. This enzyme helps to break down and remove certain types of fatty substances called "glycolipids." These glycolipids are normally present within the body in most cells. In people with Fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because alpha-galactosidase A is not present, or is present in small quantities. The build up of glycolipid levels (also referred to as "globotriaosylceramide" or "GL-3") in these tissues is thought to cause the clinical symptoms that are common to Fabry disease. Symptoms commonly appear during childhood with pain in the hands and feet. This trial is designed to evaluate the efficacy of a lower dose of Fabrazyme in patients who initially received 1.0 mg/kg every 2 weeks of Fabrazyme by investigating if the achieved clearance of glycosphingolipid deposits in the vascular endothelium of the kidney can be maintained at a lower dose.

NCT ID: NCT00191126 Completed - Clinical trials for Non-Small Cell Lung Cancer

Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Early Stages NSCLC

Start date: September 2000
Phase: Phase 3
Study type: Interventional

Preoperative chemotherapy is considered to play a role in early stage non small cell lung cancer (NSCLC) .The use of preoperative Cisplatin/Gemcitabine chemotherapy has proven feasible and without excessive morbidity or mortality in the Phase II setting. The aim of the present Phase III study is to determine whether 3 cycles of preoperative chemotherapy with Cisplatin/Gemcitabine improves progression free survival of NSCLC patients versus surgery alone. Postoperative chemotherapy will not be utilized in this Phase III trial.

NCT ID: NCT00189813 Completed - Clinical trials for Irritable Bowel Syndrome

A Study of YM060 in Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)

Start date: March 2005
Phase: Phase 2
Study type: Interventional

This study will examine the efficacy, safety and tolerability of different oral dose of YM060, 5-HT3 receptor antagonist, in patients with d-IBS.

NCT ID: NCT00179777 Completed - Clinical trials for Diabetes Mellitus, Type 1

TRIGR - Primary Prevention Study for Type 1 Diabetes in Children at Risk

TRIGR
Start date: May 6, 2002
Phase: N/A
Study type: Interventional

The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) is an international effort to conduct a primary prevention nutrition trial for type 1 (insulin-dependent) diabetes. The TRIGR study was targeted at newborns who are at genetic risk for type 1 diabetes because their mother, father and/or full sibling has type 1 diabetes. All families were encouraged to breast feed their infants for as long as possible. Prior to birth, the child was randomly assigned to receive one of two infant formulas, should formula be required prior to 8 months of age. The study determined whether weaning to a possibly protective infant formula decreases these children's chances of developing diabetes - as it does in the animal models for diabetes.

NCT ID: NCT00175877 Completed - Clinical trials for Rheumatoid Arthritis

A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

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

An open ended study in which patients who completed the double-blind study CDP870-027 [NCT00152386] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of Rheumatoid Arthritis (RA).

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: NCT00174720 Completed - Asthma Clinical Trials

Efficacy of Ciclesonide vs Placebo Administered as Once Daily or Twice Daily in Patients Not Treated With Inhaled Corticosteroid.

Start date: September 2005
Phase: Phase 3
Study type: Interventional

To investigate the efficacy of ciclesonide MDI either as once daily or twice daily in patients with mild to moderate asthma, who have not previously been treated with an inhaled corticosteroid.

NCT ID: NCT00169494 Completed - Clinical trials for Infections, Papillomavirus

Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult Women With GSK Bio HPV-16/18

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

Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GSK Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start. Approximately 750 study subjects will receive different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.

NCT ID: NCT00166244 Completed - Clinical trials for De Novo Renal Transplant Recipient.

Fixed Dose MMF vs Concentration Controlled MMF After Renal Transplantation

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

Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared with fixed dosing in de novo MMF treated renal transplant recipients with respect to the incidence of treatment failure.

NCT ID: NCT00160706 Completed - Crohn's Disease Clinical Trials

A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease

PRECiSE 4
Start date: February 2004
Phase: Phase 3
Study type: Interventional

A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn from the double-blind study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] due to an exacerbation of Crohn's Disease.