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NCT ID: NCT01201837 Completed - Clinical trials for Acute Coronary Syndrome

Effect of CER-001 on Atherosclerosis in Acute Coronary Syndrome (ACS) Patients - Efficacy and Safety: The CHI SQUARE Trial

CHI SQUARE
Start date: March 2011
Phase: Phase 2
Study type: Interventional

Cardiovascular disease remains the most pressing healthcare issue for developed countries and is becoming so for developing countries. There are a number of chronic therapies available for long-term management of risk. Short term therapies for subjects with an acute event, such as an episode of acute coronary syndrome (ACS), are focused on reperfusion and removing thrombus but most subsequent events are caused by atherosclerotic plaque rupture at a different site. There are no approved therapies that can rapidly reduce the burden of unstable, inflamed plaque in the overall coronary vascular bed. HDL has multiple actions that could lead to atherosclerotic plaque stabilization, such as rapid removal of large quantities of cholesterol from the vasculature, improvement in endothelial function, protection against oxidative damage and reduction in inflammation. This study will assess the effects of CER-001, an ApoA-I-based HDL mimetic, on indices of atherosclerotic plaque progression and regression as assessed by intravascular ultrasound (IVUS) measurements in patients with (ACS).

NCT ID: NCT01201356 Completed - Clinical trials for Relapsing Forms of Multiple Sclerosis

Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis

Start date: September 13, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that provided patients with continuous treatment until fingolimod was registered, commercially available, and reimbursed in the respective countries.

NCT ID: NCT01200420 Completed - Hepatitis C Clinical Trials

Multiple Ascending Dose Study of Miravirsen in Treatment-Naïve Chronic Hepatitis C Subjects

Start date: September 2010
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to determine the safety and tolerability of multiple dosing of miravirsen in subjects infected with chronic hepatitis C. Secondary purpose includes assessment of pharmacokinetics of miravirsen and assessment of miravirsen's effect on HCV viral titer.

NCT ID: NCT01200277 Completed - Osteoporosis Clinical Trials

A Trial of Vertebroplasty for Painful Acute Osteoporotic Vertebral Fractures

VertosIV
Start date: January 2011
Phase: Phase 3
Study type: Interventional

The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), is a new minimally invasive technique for pain treatment in which bone cement is injected in the fractured vertebra. Recent RCTs provide conflicting results: two sham-controlled studies show no benefit of PV while an unmasked but controlled RCT found significantly better pain relief after PV at acceptable costs.

NCT ID: NCT01199406 Completed - Postoperative Pain Clinical Trials

Pain Reduction After Cholecystectomy

INTENSE
Start date: July 2009
Phase: Phase 4
Study type: Interventional

To determine the effect of combined intracutaneous infiltration and intraperitoneal instillation of 80 mL 0,125% levobupivacaine prior to the start of laparoscopic cholecystectomy on abdominal pain up to 24 hours after surgery.

NCT ID: NCT01199289 Completed - Asthma Clinical Trials

A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma

Start date: October 4, 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if AMG 827 is effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.

NCT ID: NCT01198015 Completed - Rett Syndrome Clinical Trials

Creatine Metabolism in Rett Syndrome

Start date: August 2010
Phase: N/A
Study type: Observational

Rett syndrome (RTT) is an X-linked severe neurodevelopmental disorder. Despite their good appetite, many females with RTT meet the criteria for moderate to severe malnutrition. The pathological mechanism is barely understood. Although feeding difficulties may play a role in this, other constitutional factors as altered metabolic processes are suspected. Preliminary research showed elevated plasma creatine concentrations and increased urinary creatine/creatinine ratios in half of the RTT girls. The aim of this study is to confirm previous findings and examine the functionality of the creatine transporter in RTT girls. The investigators assume that previous findings will be confirmed, and are due to an altered functionality of the creatine transporter.

NCT ID: NCT01197378 Completed - Cystinosis Clinical Trials

Long-Term Safety Follow-up Study of Cysteamine Bitartrate Delayed-release Capsules (RP103)

Start date: August 27, 2010
Phase: Phase 3
Study type: Interventional

Cystinosis is an inherited disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate immediate release) which must be taken every six hours for the rest of the patient's life to prevent complications of cystinosis. Cysteamine bitartrate delayed-release capsules (RP103) is a formulation of cysteamine bitartrate that is being studied to see if it can be given less frequently, once every 12 hours, and have similar results to four times a day Cystagon®.

NCT ID: NCT01196871 Completed - Fabry Disease Clinical Trials

Drug-Drug Interaction Study Between AT1001 (Migalastat Hydrochloride) and Agalsidase in Participants With Fabry Disease

Start date: February 2, 2011
Phase: Phase 2
Study type: Interventional

The objective was to determine the effects of a single dose of migalastat hydrochloride (HCl) (migalastat) 150 and 450 milligrams (mg) on the safety and plasma pharmacokinetics (PK) of agalsidase and the effects of agalsidase on the safety and PK of migalastat 150 mg.

NCT ID: NCT01196221 Completed - Atherosclerosis Clinical Trials

Technical Innovation Protocol for MR & US Plaque Imaging: Reproducibility.

Start date: November 2009
Phase: N/A
Study type: Observational

The aim of this study is to develop non-invasive MRI, and MRS approaches that will quantify the plaque composition and lipid content of plaques and will have the potential for repeated in vivo measurements. Simultaneously this study aims to develop US plaque imaging as a screening tool to select plaque phenotypes of interest for clinical trials (a large LRNC). For plaque composition imaging by MRI the researchers aim to increase scan resolution and decrease scan time. For quantifying plaque lipid content the researchers aim to develop an MRS protocol. Subsequently, the researchers intend to study the reproducibility of plaque composition and lipid content measurements by MRI, MRS and Ultrasound in subjects that have carotid artery plaques.