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NCT ID: NCT00358150 Active, not recruiting - Clinical trials for Gaucher Disease, Type 1

A Study of the Efficacy and Safety of Eliglustat Tartrate (Genz-112638) in Type 1 Gaucher Patients

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

Gaucher disease is a genetic disease that results in a deficiency of an enzyme acid beta-glucosidase, also known as glucocerebrosidase. This enzyme is needed to digest a substrate (lipid) called glucosylceramide and, to a lesser degree, glucosylsphingosine. In participants with Gaucher disease, the liver, spleen, bone marrow and brain show increases in lipid concentration, specifically in cells derived from the monocyte/macrophage system. Eliglustat tartrate (Genz-112638) is an oral drug that may regulate the Gaucher disease process by decreasing the synthesis of glucosylceramide. The primary objective of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of eliglustat tartrate, administered as an oral dose of either 50 milligram (mg) twice daily (BID) or 100 mg BID, to men and women with Gaucher disease Type 1 for 52 weeks.

NCT ID: NCT00357123 Recruiting - Sepsis Clinical Trials

Effect of Rosuvastatin in Abdominal Sepsis

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

The purpose of this study is to determine whether rosuvastatin is effective as a coadjuvant drug in the integral management of abdominal sepsis acknowledged by surgery.

NCT ID: NCT00356109 Completed - Clinical trials for Diabetes Mellitus, Type 1

Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes

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

A study to test for non-inferiority of preprandial HIIP [also known as AIR® Inhaled Insulin Powder][AIR® is a registered trademark of Alkermes,Inc.] compared with preprandial injectable insulin (insulin lispro) with respect to HbA1c after 6 months of treatment in patients with type 1 diabetes mellitus. This study is designed also to examine insulin antibody levels in AIR Insulin -treated patients compared with injectable insulin-treated patients with type 1 diabetes. The present study is intended to determine if preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint at 6 months in patients with type 1 diabetes.

NCT ID: NCT00354627 Completed - HIV-1 Clinical Trials

The TMC125-C214 Study Provides Early Access to TMC125 for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens and Will Also Gather Information on the Long-term Safety and Tolerability of TMC125 Combined With Other Antiretroviral Drugs

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

The purpose of this study is to provide early access of TMC125 to HIV-1 infected patients who have failed multiple antiretroviral (ARV) regimens. Information on safety and tolerability aspects of TMC125 in combination with other ARVs in treatment-experienced HIV-1 patients with limited treatment options will be assessed. Available data regarding the effectiveness of the drug will also be collected. To be eligible, patients should be failing their current ARV regimen or be on a treatment interruption, should have previously received 2 different protease inhibitor (PI) containing regimens and be at least 3-class experienced (protease inhibitors [PI], nucleoside/tide reverse transcriptase inhibitors [N[t]RTIs] and non-nucleoside reverse transcriptase inhibitors [NNRTIs]) or at least 2-class experienced (PIs and N[t]RTIs) with primary NNRTI resistance. TMC125 will be administered in combination with an investigator-selected background of additional ARVs from the list of allowed medications.

NCT ID: NCT00354341 Completed - Anemia Clinical Trials

(ACORD Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Early Diabetic Nephropathy

Start date: n/a
Phase: Phase 3
Study type: Interventional

This study will assess the effect of anemia correction with NeoRecormon on cardiac structure and function in patients with early diabetic nephropathy. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

NCT ID: NCT00354094 Terminated - Pain Clinical Trials

[S,S]-Reboxetine Long Term Safety Study In Post-Shingles Pain.

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

The purpose of this study is to assess the long term (up to 2 years) safety and tolerability of [S,S]-Reboxetine in patients with pain after shingles.

NCT ID: NCT00353444 Suspended - Head Injury Clinical Trials

Transcranial Doppler Measurement and Prognosis in Moderate Head Injury

Start date: December 2006
Phase: Phase 2/Phase 3
Study type: Observational

The purpose of this study is to determine whether Transcranial Doppler measurements have correlation with neuropsychological test (Galvestone Orientation Amnesia Test), TC image (Marshall Scale) and prognosis (DRS and GOS) in moderate head injury

NCT ID: NCT00351611 Completed - Epilepsies, Partial Clinical Trials

Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo

Start date: July 26, 2006
Phase: Phase 4
Study type: Interventional

Patients with partial seizures currently taking 1-3 antiepileptic medications will have a 50:50 chance to receive Lyrica 300 mg per day or placebo (no active ingredients) added on to their current medications for 3 months. Neither the study doctor nor the patient will know the medication assignment. Vision testing will be performed prior to receiving the study treatment and at the end of the study to see if there are any changes.

NCT ID: NCT00351169 Completed - Clinical trials for Major Depressive Disorder

Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder

AMBER
Start date: May 2006
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of quetiapine fumarate sustained release (Seroquel SR) in the treatment of Major Depressive Disorder. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

NCT ID: NCT00348309 Completed - Alzheimer's Disease Clinical Trials

Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy For Subjects With Mild To Moderate Alzheimer's Disease

REFLECT-2
Start date: July 6, 2006
Phase: N/A
Study type: Interventional

Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a treatment for type II diabetes mellitus, a disease that occurs when the body is unable to effectively use glucose. RSG XR, the investigational drug used in this study, is an extended-release form of RSG. This study tests whether RSG XR safely provides clinical benefit to people with mild to moderate Alzheimer's disease (AD) when combined with the currently approved AD medication, Aricept (donepezil). RSG XR is a new approach to AD therapy and this study tests a new way to treat AD by testing whether one's genetic makeup affects their response to the study drug. Clinical data suggesting that RSG may benefit AD patients was first seen in a small study performed at the University of Washington and then from a larger GSK study conducted in Europe and New Zealand. In the first study, subjects receiving RSG once daily for 6 months scored significantly better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that appeared to benefit most from treatment with RSG XR had a specific genetic pattern. They did not have the gene that caused them to produce the protein apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene, instead of APOE e4, from one of their parents. Subjects with one copy of the APOE e4 gene remained at their same level of thinking ability while those with two copies of the APOE e4 gene, continued to worsen during the 6-month treatment. The current study will more directly test the effectiveness or RSG XR on people who either have or lack the APOE e4 gene.