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NCT ID: NCT01603095 Completed - Achondroplasia Clinical Trials

A Multicenter, Multinational Clinical Assessment Study for Pediatric Patients With Achondroplasia

Start date: April 2012
Phase:
Study type: Observational

Multicenter, multinational study to collect consistent baseline growth measurements on pediatric patients with Achondroplasia being considered for subsequent enrollment in future studies sponsored by BioMarin. No study drug is administered.

NCT ID: NCT01602549 Completed - Gastroparesis Clinical Trials

A Study to Assess the Effect of Repeat Doses of GSK962040 on the Pharmacokinetics of L-DOPA in Subjects With Parkinson's Disease Exhibiting Delayed Gastric Emptying

Start date: July 2012
Phase: Phase 2
Study type: Interventional

Gastric emptying is the end-result of a complex and carefully regulated series of events which follow the ingestion of a meal, each of which is dependent on the other and subject to neurohormonal control. Motilin is an endogenous peptide, produced mainly in the duodenum, whose physiological action is mediated by motilin receptors located on enteric neurons, peripheral terminals of the vagus, and on the smooth muscle of the gut. Motilin and non-peptide agonists at motilin receptors increases the gastric emptying rate and therefore provide a potential approach to the treatment of a range of clinical conditions in which delayed gastric emptying is thought to be part of the physiopathology and may be contributory to symptoms. Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by degeneration of nigrostriatal dopaminergic neurones. It affects 1.5% of the global population over 65 years of age. Cardinal symptoms comprise bradykinesia, rigidity, resting tremors and postural instability. Gastrointestinal dysfunction, including gastroparesis, is a frequent feature of PD affecting approximately 90% of patients, and is caused by autonomic dysfunction as well as an adverse effect of antiparkinsonian drug therapy. The therapeutic mainstay for PD treatment is the neutral amino acid L-3,4-dihydroxyphenylalanine (L-DOPA), a dopamine prodrug, as it provides the most rapid and effective symptomatic control of motor impairment in PD. The primary determinant of L-DOPA bioavailability is gastric emptying (GE); delays in GE slow delivery of L-DOPA to its proximal small intestinal absorption sites, increasing the extent of presystemic metabolism, and leading to slowed and diminished absorption.

NCT ID: NCT01602341 Completed - Dermatitis, Atopic Clinical Trials

Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis

Start date: August 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of AN2728 Topical Ointment, 2% and 0.5%, administered once a day (QD) or twice a day (BID), in the treatment of adolescents with atopic dermatitis (AD)

NCT ID: NCT01600014 Completed - Actinic Keratosis Clinical Trials

Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp

Start date: May 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to demonstrate that ingenol mebutate gel is efficacious in treating Actinic Keratoses (AKs) present 8 weeks after initial field treatment or emerging in a previously cleared field.

NCT ID: NCT01599650 Completed - Clinical trials for Branch Retinal Vein Occlusion

Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion

BRIGHTER
Start date: May 2012
Phase: Phase 3
Study type: Interventional

This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing administered with or without adjunctive laser treatment versus laser photocoagulation (the current standard of care) up to Month 6 in patients with visual impairment due to ME secondary to BRVO. Additionally the results of this study will provide long-term (24-month) safety and efficacy data for ranibizumab, administered with or without adjunctive laser treatment in this indication.

NCT ID: NCT01598987 Completed - Liver Transplant Clinical Trials

Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.

Start date: October 2012
Phase: Phase 3
Study type: Interventional

This study is designed to assess the evolution of renal function and to collect efficacy, safety, and tolerability data of everolimus in co-exposure with reduced CNI in paediatric liver transplant recipients.

NCT ID: NCT01598831 Completed - Severe Sepsis Clinical Trials

Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy

Start date: October 29, 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.

NCT ID: NCT01597908 Completed - Melanoma Clinical Trials

Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma

COMBI-v
Start date: June 4, 2012
Phase: Phase 3
Study type: Interventional

This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.

NCT ID: NCT01597245 Completed - Psoriasis Clinical Trials

A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2)

UNCOVER-2
Start date: May 18, 2012
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.

NCT ID: NCT01596595 Completed - Clinical trials for Primary Prevention of Sudden Cardiac Arrest

Longitudinal Surveillance Study of the 4-SITE Lead/Header System

LSS of 4-SITE
Start date: April 4, 2013
Phase:
Study type: Observational

Post-approval studies of implanted leads provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting. The goal of the study is to evaluate, document and report on the appropriate clinical performance, long-term reliability and the functional integrity of the Boston Scientific ENDOTAK RELIANCE® 4-SITEā„¢ Lead and the pulse generator 4-SITE Header.