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NCT ID: NCT01081145 Completed - Clinical trials for Attention-deficit/Hyperactivity Disorder

Maintenance of Efficacy of Extended-Release Guanfacine HCl in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)

Start date: May 11, 2010
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term maintenance of efficacy of Extended-Release Guanfacine HCl in children and adolescents (6-17 years) with attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label, short term treatment with SPD503.

NCT ID: NCT01080768 Terminated - Hypertension Clinical Trials

Assessment of Aliskiren/Amlodipine and Amlodipine on Ankle Foot Volume (AFV) in Patients With Hypertension

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

The purpose of the present study was to evaluate the addition of aliskiren, to amlodipine can attenuate ankle edema formation in hypertensive patients.

NCT ID: NCT01080508 Completed - Clinical trials for Esophageal Intubation

Spirometry in Esophageal Intubation

Start date: December 2009
Phase:
Study type: Observational

The primary objective of the study is to describe the pressure patterns during esophageal and tracheal ventilation and to validate the diagnostic algorithm.

NCT ID: NCT01080391 Completed - Clinical trials for Relapsed Multiple Myeloma

Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma

Start date: July 14, 2010
Phase: Phase 3
Study type: Interventional

The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting.

NCT ID: NCT01080131 Completed - Acute Gout Clinical Trials

Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.

ß-RELIEVED-II
Start date: March 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and/ or colchicine are contraindicated, not tolerated, or ineffective. The efficacy of canakinumab was compared to the corticosteroid triamcinolone acetonide. The purpose of the first 12 week extension study was to collect additional safety, tolerability and efficacy data in patients who have completed the core study CACZ885H2357. The purpose of the second one year open-label extension study was to confirm the long-term safety and tolerability of canakinumab in patients who had completed the first extension study.

NCT ID: NCT01079702 Unknown status - Clinical trials for Advanced Malignancies

Everolimus and Capecitabine in Patients With Advanced Malignancy

m-TOR
Start date: April 2008
Phase: Phase 1/Phase 2
Study type: Interventional

In the investigators study the investigators combine everolimus, administrated twice daily at a fixed total dose of 10 mg continuously with capecitabine administered bid for 14 days followed by 7 days rest. In this study, capecitabine will be dose escalated.

NCT ID: NCT01079364 Terminated - Clinical trials for Diabetes Mellitus, Type 2

Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting

BASAAL PLUS
Start date: January 2010
Phase: Phase 4
Study type: Interventional

Primary Objective: To demonstrate non-inferiority of once daily injection of insulin glargine (Lantus) plus one injection of mealtime insulin glulisine (Apidra) at the main meal versus twice daily premixed insulin (NovoMix 30/70) based on the reduction of HbA1c percentage from baseline to endpoint. Secondary Objective: - To determine treatment satisfaction (DTSQs/Diabetes Treatment Questionnaire - Status, DTSQc/ Diabetes Treatment Questionnaire - change and ITSQ/Insulin Treatment Satisfaction Questionnaire) - To determine the mean HbA1c, FBG (Fasting Blood Glucose), prandial BG (Blood Glucose) and proportion of patients with a HbA1c <7% - To determine the effect on adverse events (e.g. symptomatic hypoglycemic events, weight gain and injection site reactions) - To determine the total insulin dose, average insulin glargine, insulin glulisine and premixed insulin dosages.

NCT ID: NCT01079286 Completed - Cancer Clinical Trials

Study of Nelfinavir and Temsirolimus in Patients With Advanced Cancers

I-NET
Start date: June 2009
Phase: Phase 1
Study type: Interventional

In the present study the investigators want to explore the safety, pharmacokinetics, and activity of the combination of temsirolimus and nelfinavir, both agents with PI3K /Akt/mTOR inhibiting activity, in patients with advanced malignancies.Temsirolimus has proven anti tumoral activity by mTOR inhibition. Nelfinavir is a potential inhibitor of Akt. Combining both agents might prevent upregulation of the P13k pathway and increase the anti-cancer activity of temsirolimus. The strong CYP3A4 inhibition of nelfinavir and the dependence of temsirolimus on CYP3 A4 metabolism makes a dose finding study essential. The investigators will also look at the prospective value of biomarkers of activity and the outcome of the treatment.

NCT ID: NCT01078675 Completed - Clinical trials for Familial Hypercholesterolaemia

An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial Hypercholesterolaemia

Start date: February 2010
Phase: Phase 3
Study type: Interventional

This study is being carried out to see if the study medication, rosuvastatin, is effective in treating familial hypercholesterolaemia in children and adolescents, and to determine the long term (over 2 years) safety, tolerability and efficacy of the study medication in these patients. This study will also measure levels of drug in the blood and see how well it is tolerated. This is known as pharmacokinetic (PK) analysis. At baseline only a small number of patients will participate in a single dose PK phase over 24 hours. In order to see if this medication works, a control group of healthy siblings will help the researchers to compare certain results.

NCT ID: NCT01077999 Completed - Esophageal Cancer Clinical Trials

Chemoradiation and Panitumumab for Esophageal Cancer

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

A consistent finding in many studies in patients with operable esophageal and gastro-esophageal junction (GEJ) cancer is that response to preoperative therapy, particularly the absence of residual disease in the surgical specimen, is an indicator of better disease-free and overall survival. Therefore in the investigators trial the investigators will evaluate the pathologic response of panitumumab in combination with neoadjuvant chemoradiation as first line treatment of operable adenocarcinomas, undifferentiated or squamous cell carcinomas of the esophagus.