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NCT ID: NCT01747915 Completed - Clinical trials for Generalized Tonic Clonic Seizures

A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.

Start date: April 3, 2013
Phase: Phase 3
Study type: Interventional

The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.

NCT ID: NCT01747837 Completed - Clinical trials for Ventricular Tachycardia

REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients

RESCUE
Start date: October 22, 2015
Phase: N/A
Study type: Interventional

The objective of this trial is to determine the efficacy and safety of adjunctive catheter-based renal sympathetic denervation (RSDN) in the primary prevention of implantable cardioverter defibrillator (ICD) therapy in patients with ischemic or non-ischemic ventricular dysfunction, who are to receive an ICD for either i) secondary prevention, or ii) primary prevention + inducible ventricular tachycardia (VT) by programmed ventricular stimulation at the time of ICD implantation. These patients will be randomized to ICD alone or ICD + RSDN.

NCT ID: NCT01747330 Completed - Clinical trials for Pancreatic Exocrine Insufficiency

Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency

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

The purpose of this study is to evaluate the safety and tolerability of Creon micro in children younger than four years with pancreatic exocrine insufficiency.

NCT ID: NCT01746108 Completed - Clinical trials for Infections, Streptococcal

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine (Synflorix™) When Administered to Children Who Are at an Increased Risk of Pneumococcal Infection

Start date: June 18, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' 10Pn-PD-DiT vaccine in children aged between 2 and 17 years of age having asplenia, splenic dysfunction or complement deficiencies. In addition, this study will include an age-matched control group of healthy children aged 24-59 months in order to descriptively compare the immunogenicity of 10Pn-PD-DiT vaccine in the at-risk population to that of the general, healthy population one month after each pneumococcal vaccination.

NCT ID: NCT01743651 Completed - Multiple Sclerosis Clinical Trials

Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis

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

This is a multicenter, randomized (1:1:1), double-blind, active and placebo controlled, parallel group study to evaluate safety, tolerability and efficacy of oral arbaclofen in MS patients with spasticity. Eligible subjects will be removed from anti-spasticity medications for at least one week and then begin study drug treatment with daily doses increasing up to the target dose which will then be maintained for at least 12 weeks. A down-titration will then occur over two weeks.

NCT ID: NCT01743001 Completed - Clinical trials for Pulmonary Arterial Hypertension

Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome

MAESTRO
Start date: May 21, 2013
Phase: Phase 3
Study type: Interventional

Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects with Eisenmenger Syndrome.

NCT ID: NCT01742052 Completed - Clinical trials for Relapsing-remitting Multiple Sclerosis

Dose-finding Study of MT-1303

Start date: January 2013
Phase: Phase 2
Study type: Interventional

The primary objectives of the study are: - To evaluate the effects of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on MRI parameters - To evaluate the safety and tolerability of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with RRMS.

NCT ID: NCT01741545 Completed - Hepatitis C Virus Clinical Trials

Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia

MAGNITUDE
Start date: March 31, 2013
Phase: Phase 3
Study type: Interventional

The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with Genotype(GT)-1b, -4 and GT-2, -3

NCT ID: NCT01740427 Completed - Breast Neoplasms Clinical Trials

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

Start date: February 22, 2013
Phase: Phase 3
Study type: Interventional

The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.

NCT ID: NCT01740089 Completed - Hepatitis C Clinical Trials

Algeron (Cepeginterferon Alfa-2b) Compared With PegIntron (Peginterferon Alfa-2b) for Treatment of Chronic Hepatitis C

Start date: November 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to demonstrate the noninferiority of Algeron 1.5 and 2.0 μg/kg/week in combination with ribavirin compared to PegIntron in combination with ribavirin in the treatment of chronic hepatitis C, and to determine therapeutic dose of Algeron.