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NCT ID: NCT01931839 Completed - Clinical trials for Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis

Start date: October 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of long-term treatment with lumacaftor in combination with ivacaftor in people 12 years and older with Cystic Fibrosis.

NCT ID: NCT01929330 Completed - Alopecia Clinical Trials

Bioequivalence Study of Dutasteride Five 0.1 mg and One 0.5 mg Soft Gelatin Capsules in Healthy Male Volunteers

Start date: September 23, 2013
Phase: Phase 1
Study type: Interventional

The aim of this study is to determine the bioequivalence of 5 x 0.1 milligram (mg) capsules compared to 1 x 0.5 mg capsule of dutasteride in healthy male subjects. The results of this study are expected to support registration applications for androgenetic alopecia (AGA) in Japan and other international markets.

NCT ID: NCT01928771 Completed - Asthma Clinical Trials

Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

Start date: September 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.

NCT ID: NCT01928537 Completed - Clinical trials for Myelodysplastic Syndromes

Efficacy and Safety of IV Rigosertib in MDS Patients With Excess Blasts Progressing After Azacitidine or Decitabine

Start date: August 2013
Phase: Phase 3
Study type: Interventional

This study will examine the effect intravenously administered rigosertib has on the relationship between bone marrow blasts response and overall survival in myelodysplastic syndromes (MDS) patients who have 5-30% bone marrow blasts and who progressed on or after treatment with azacitidine or decitabine.

NCT ID: NCT01928459 Completed - Clinical trials for Advanced Solid Tumors

Phase 1b Trial of BGJ398/BYL719 in Solid Tumors

Start date: October 2013
Phase: Phase 1
Study type: Interventional

To study the safety and efficacy of the combination of BGJ398 with BYL719 in patients whose tumors express mutations to PIK3CA with or without alterations to FGFR 1-3.

NCT ID: NCT01927510 Completed - Critically Ill Clinical Trials

TEAM: A Trial of Early Activity and Mobility in ICU

TEAM-RCT
Start date: August 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Patients in the intensive care unit (ICU) traditionally receive bed rest as part of their care. They develop muscle weaknesses even after only a few days of mechanical ventilation that may prolong their time in ICU and in hospital, delay functional recovery and delay their return home and to work. Weakness may be avoided with simple strategies of early exercise in ICU. This pilot study aims to test the hypothesis that early mobilisation may improve functional recovery in this patient group and gather pilot data to support a larger randomised trial across Australia and New Zealand.

NCT ID: NCT01927068 Completed - Clinical trials for Peripheral Arterial Disease

STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR)

ILLUMENATE
Start date: July 2013
Phase: N/A
Study type: Interventional

Cohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of the Stellarex 035 Drug Coated Balloon (formerly known as the Cardiovascular Ingenuity (CVI) Paclitaxel-Coated PTA Balloon Catheter) in the treatment of de novo or restenotic lesions in the superficial femoral and/or popliteal arteries. Cohort 2: To evaluate this patient population for treatment of in-stent restenotic lesions.

NCT ID: NCT01925768 Completed - Psoriatic Arthritis Clinical Trials

Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis

Start date: September 4, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether apremilast is safe and effective for treating patients with psoriatic arthritis.

NCT ID: NCT01925430 Completed - Healthy Clinical Trials

The Evaluation of a New Sleep Algorithm

Start date: November 2013
Phase: N/A
Study type: Observational

A new device is being developed to screen for sleep-breathing disorders. Within this device is a new software algorithm which will determine sleep/wake states. The aim of this study is to evaluate the performance of this new algorithm. This prototype will be compared against a commercially available device which monitors sleep/wake patterns. Volunteers will be asked to wear the prototype and comparative devices for 1-2 nights. The data from both devices will be downloaded after the completion of the study and analysis wil be performed to compare the two recordings.

NCT ID: NCT01925209 Completed - Clinical trials for Sporadic Inclusion Body Myositis

Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients

RESILIENT
Start date: September 26, 2013
Phase: Phase 2/Phase 3
Study type: Interventional

This study evaluated the efficacy, safety and tolerability of multiple doses of bimagrumab/BYM338 vs placebo, when administered intravenously (i.v.), on physical function, muscle strength, and mobility in patients with sporadic inclusion body myositis (sIBM).