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NCT ID: NCT01342952 Completed - Clinical trials for Hypertension, Pulmonary

Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529

Start date: June 21, 2011
Phase: Phase 2
Study type: Interventional

An open label, long term extension to Study AMB112529. All subjects may remain in the extension study for a minimum of six months. Beyond the six month period, subjects may continue in the extension study until one of the following conditions is met: the subject turns 18 years of age (when the subject can receive marketed product) the product is approved and available for use in the subject's age group, development for use in the paediatric population is discontinued. the subject decides he/she no longer wants to participate in the study, the investigator considers it is in the best interest of the subject to discontinue ambrisentan (e.g. for safety reasons). The primary objective is the long-term safety and tolerability of ambrisentan in the paediatric PAH population. Secondary objectives are all cause mortality and change from baseline in Study AMB112529 on efficacy parameters.

NCT ID: NCT01342913 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Study to Evaluate the 24 Hour Spirometric Effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate (FF)/25mcg Vilanterol (VI)) Compared With Salmeterol/Fluticasone Propionate Inhalation Powder (50mcg Salmeterol/500mcg Fluticasone Propionate (FP))

Start date: February 1, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol 100/25mcg once daily compared with Salmeterol/Fluticasone Propionate 50/500mcg twice daily over a 12-week treatmen period in subjects with COPD.

NCT ID: NCT01342484 Completed - Clinical trials for Diabetes Mellitus, Type 2

Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes

Start date: April 2011
Phase: Phase 2
Study type: Interventional

The main objective of this study is to identify the dose of linagliptin in paediatric patients. Other efficacy objectives include the comparison of the lowering effect of linagliptin low dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of treatment. Furthermore, the study will investigate the pharmacokinetics (PK), the pharmacodynamics (PD) and the PK/PD relationship of linagliptin in the paediatric population.

NCT ID: NCT01340664 Completed - Clinical trials for Diabetes Mellitus, Type 2

An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy

Start date: July 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.

NCT ID: NCT01340027 Completed - Urologic Diseases Clinical Trials

A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder

Symphony
Start date: March 29, 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine how well two medicines in combination (solifenacin succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.

NCT ID: NCT01339559 Completed - Epilepsy Clinical Trials

Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy

BRITEā„¢
Start date: May 11, 2011
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).

NCT ID: NCT01339260 Completed - Clinical trials for Chemotherapy-Induced Nausea and Vomiting

An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting

Start date: April 2011
Phase: Phase 3
Study type: Interventional

NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with oral dexamethasone. The objective of the study is to demonstrate that netupitant and palonosetron are more effective than palonosetron alone, to prevent nausea and vomiting induced by moderately emetogenic cancer chemotherapy after administration of repeated cycles of chemotherapy.

NCT ID: NCT01339091 Completed - Clinical trials for Surgical Site Infection

Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Start date: March 2011
Phase: Phase 3
Study type: Interventional

The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proven gram-positive bacterial skin or skin structure infection.

NCT ID: NCT01338961 Completed - Clinical trials for Valvular Heart Disease

Normothermia Versus Hypothermia for Valvular Surgery Patients

Start date: April 2011
Phase: N/A
Study type: Interventional

Cardiopulmonary bypass (CPB) has been used successfully for cardiac surgery for over half a century. Hypothermia became a ubiquitous practice for adult patients undergoing CPB. To date, most studies have been conducted in coronary artery bypass graft (CABG) patients with conflicting results. Current evidence does not support one temperature management strategy for all patients. The purpose of this study is to compare the efficiency and safety of normothermic versus hypothermic CPB in valvular surgery patients.

NCT ID: NCT01338415 Completed - Clinical trials for Pulmonary Arterial Hypertension

FUTURE 3 Study Extension

FUTURE 3 Ext
Start date: March 8, 2011
Phase: Phase 3
Study type: Interventional

The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).