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NCT ID: NCT00607373 Completed - Clinical trials for Hypercholesterolemia

Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia

RADICHOL 1
Start date: July 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of mipomersen (ISIS 301012) in subjects with homozygous familial hypercholesterolemia on lipid-lowering therapy. This study consisted of a 26-week treatment period and a 24-week post-treatment follow-up period. Following treatment and Week 28 evaluations, participants could elect to enroll in an open-label extension study (301012-CS6; NCT00694109). Participants who were not eligible or elected not to enroll in the open-label extension study or who discontinued during the 28-week treatment period were followed in this study for 24 weeks from administration of the last dose of study drug.

NCT ID: NCT00607334 Completed - Clinical trials for Developmental Language Disorders

Experimental Word Learning in Children With and Without Language Impairment

Start date: July 2003
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the performances of normally developing children and children with Language Impairment (LI) in three different experimental settings designed to promote vocabulary acquisition. This comparison will also provide evidence to support different intervention approaches designed to increase vocabulary abilities, which has been proved to be one of the major deficits of young children with LI.

NCT ID: NCT00606502 Completed - Clinical trials for Non-small Cell Lung Cancer

Study of Pralatrexate vs. Erlotinib for Non-Small Cell Lung Cancer After at Least 1 Prior Platinum-based Treatment

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

The purpose of this clinical study is to determine the effectiveness (ability to provide beneficial treatment of the disease) and safety of pralatrexate compared to erlotinib when given to non-small cell lung cancer (NSCLC) patients who are current or former cigarette smokers and who have received at least 1 prior treatment with a platinum drug (cisplatin or carboplatin)

NCT ID: NCT00605683 Completed - Clinical trials for Idiopathic Parkinson's Disease

MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist

MOTION
Start date: November 2007
Phase: Phase 3
Study type: Interventional

Parkinson's disease is a major neurodegenerative disorder in which there is a progressive loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO B, the major DA metabolising enzyme in man. This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects with early idiopathic Parkinson's Disease. The principal efficacy measure, i.e., change in mean value of UPDRS - Section III total score from baseline to endpoint, was chosen based on regulatory guidance and prior use in other trials in similar populations.

NCT ID: NCT00605540 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Markers and Prognosis

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

The study aim is to verify the association between the changes in markers of disease and patient´s prognosis in chronic obstructive pulmonary disease.

NCT ID: NCT00605280 Completed - Clinical trials for Macular Edema Associated With Diabetes Mellitus

A Multi-Center Trial To Evaluate The Safety And Efficacy Of Pegaptanib Sodium(Macugen) Injected Into The Eye Every 6 Weeks For Up To 2 Years For Macular Swelling Associated With Diabetes, With An Open-Label Macugen Year Extension.

Start date: September 2005
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. The safety of Macugen compared to standard of care laser will also be evaluated.

NCT ID: NCT00605098 Completed - HIV Infections Clinical Trials

Pharmacokinetics of the Tablet Formulation of Lopinavir/r as Standard and Increased Dosage During Pregnancy

Start date: February 2008
Phase: Phase 4
Study type: Interventional

This is a multicenter, open, prospective and randomized study aimed at evaluating the pharmacokinetics of the tablet formulation of lopinavir/r administered in combination with two nucleoside analogs to HIV-infected pregnant women at two different dosages: - Group 1 (standard dosage): 200/50 mg lopinavir/r, 2 tablets every 12 hours, plus two nucleoside analogs. - Group 2 (increased dosage): 200/50 mg lopinavir/r, 2 tablets every 12 hours until the end of the second trimester of gestation (24 weeks) and 3 tablets every 12 hours in the third trimester (from 25 weeks on), plus two nucleoside analogs. Treatment will be initiated at any time between 14 and 30 weeks of gestation and will be maintained for at least 6 weeks after delivery. The objectives are: - To compare the pharmacokinetic parameters of the standard and increased dosage of the tablet formulation of lopinavir/r during pregnancy. - To determine whether the standard and/or increased dosage of the tablet formulation of lopinavir/r during pregnancy confers the same exposure to the drug as that observed in the same women after the end of pregnancy and in historic controls. - To evaluate the transplacental passage of lopinavir/r based on the ratio between the serum concentration in maternal blood at the time of delivery and in cord blood of the two drug dosages (standard and increased) administered during pregnancy. - To evaluate the tolerability of the two lopinavir/r dosages (standard and increased) during pregnancy. - To describe the vertical transmission rate of HIV to the children of the pregnant women included in the study.

NCT ID: NCT00604747 Completed - Stroke Clinical Trials

Practice Structure on Motor Learning in Post-Stroke Patients

Start date: August 2006
Phase: N/A
Study type: Interventional

Background: The literature indicates that, in relation to motor learning, healthy subjects benefit more from random practice than from constant practice. However, this effect is not well known in post-stroke patients. Objective: The goal of this study was to investigate the effects of practice structure on motor learning in post-stroke patients. Methods: Participants included an experimental group (EG) of post-stroke patients: 17 males and females; and a control group (CG) of healthy individuals: 17 males and females. At the acquisition phase, all participants performed 30 trials of a coincident timing task. Nine individuals from each group practiced constantly (C) at a stimulus propagation speed of 3 mph, and eight from each group practiced randomly (R) at speeds of 2, 3, and 5 mph. Subsequent phases included: 1) transfer, 2) retention after 15 minutes, and 3) retention after 3 days. Each of these phases included 20 trials: 10 at a speed of 1 mph, and 10 at a speed of 4 mph. Intra- and inter-group comparisons were made employing an alpha level of 0.05 (5%).

NCT ID: NCT00604214 Completed - Sepsis Clinical Trials

Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock

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

The purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated) treatment provides significant mortality reduction improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock. This study will also assess the effectiveness of drotrecogin alfa (activated) in reducing 28-day mortality in patients with septic shock and concomitant severe protein C deficiency.

NCT ID: NCT00604175 Completed - HIV Infections Clinical Trials

Safety of and Immune Response to the Human Papillomavirus (HPV) Vaccine in HIV-Infected Women

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

Human papillomavirus (HPV) is the most common sexually transmitted disease in the world. HPV infection can cause genital warts and certain cervical problems, including cervical cancer. HPV infection may be more severe and harder to treat in HIV-infected people. The purpose of this study was to determine whether the quadrivalent HPV vaccine is safe, tolerable, and effective in producing antibodies to HPV in HIV-infected women.