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NCT ID: NCT02058576 Completed - Urologic Diseases Clinical Trials

Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin HCl Combination Capsule in Fed State

Start date: February 11, 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the bioequivalence of the second generation dutasteride and tamsulosin hydrochloride (HCL) combination capsule versus currently available commercial combination of dutasteride 0.5 milligrams (mg) and tamsulosin HCL 0.4 mg capsule in healthy adult male subjects. Subjects in this study will receive either a single oral dose of the second generation dutasteride 0.5 mg and tamsulosin 0.4 mg combination capsule or a single dose of commercially available combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg capsule followed by a 28-day washout period both in fed state. The study will enroll approximately 92 healthy adult male subjects in order to complete approximately 76 evaluable subjects. The total duration of a subject's involvement in this study is anticipated to be approximately 12 weeks.

NCT ID: NCT02058459 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Targeted Lung Denervation for Patients With Moderate to Severe COPD

AIRFLOW
Start date: August 4, 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate safety of Targeted Lung Denervation (or TLD) in patients suffering from moderate to severe COPD. It is hypothesized that TLD will have a similar safety profile and improved physiological and functional outcomes to a sham-control.

NCT ID: NCT02058147 Completed - Type 2 Diabetes Clinical Trials

Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM

LixiLan-O
Start date: February 2014
Phase: Phase 3
Study type: Interventional

Primary Objective: To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in HbA1c change from baseline to week 30. Secondary Objective: To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination to insulin glargine alone and to lixisenatide alone (on top of metformin treatment) over a 30 week treatment period in patients with type 2 diabetes

NCT ID: NCT02057913 Completed - Clinical trials for Locally-advanced or Metastatic Penile Neoplasms

A Phase II Trial of Vinflunine Chemotherapy in Locally-advanced and Metastatic Carcinoma of the Penis (VinCaP)

VinCaP
Start date: March 17, 2014
Phase: Phase 2
Study type: Interventional

VinCaP is a multicentre single-arm phase II trial. 22 patients will receive Vinflunine chemotherapy (Vinflunine 320mg/m2 given intravenously on day 1 of each cycle of 21 days, four cycles to be given prior to formal re-staging).

NCT ID: NCT02057718 Completed - Clinical trials for Progressive Familial Intrahepatic Cholestasis (PFIC)

Open Label Study to Evaluate Efficacy and Long Term Safety of LUM001 (Maralixibat) in the Treatment of Cholestatic Liver Disease in Patients With Progressive Familial Intrahepatic Cholestasis

INDIGO
Start date: March 1, 2014
Phase: Phase 2
Study type: Interventional

This is an open label study in children with Progressive Familial Intrahepatic Cholestasis (PFIC) designed to evaluate the safety and efficacy of LUM001, also known as Maralixibat (MRX). Efficacy will be assessed by evaluating the effect of LUM001 on pruritus and the biochemical markers of pruritus associated with PFIC.

NCT ID: NCT02057484 Completed - Kidney Transplant Clinical Trials

A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant

ADDRESS
Start date: March 3, 2014
Phase:
Study type: Observational

The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft recipients. This study will also evaluate the overall long-term impact of Advagraf on kidney and liver allograft recipients.

NCT ID: NCT02057471 Completed - Anemia Clinical Trials

Intravenous Iron: Measuring Response in Anemic Surgical Patients

Start date: September 2009
Phase: Phase 4
Study type: Interventional

20 Patients will be recruited with confirmed colorectal adenocarcinoma and anemia who are planned to undergo surgery. All patients will be treated with a single dose of 1g intravenous ferric carboxymaltose (FERINJECT). It is hypothesized that intravenous iron supplementation is efficacious at raising haemoglobin levels and reduced blood transfusion requirements.

NCT ID: NCT02056808 Completed - Clinical trials for Duchenne Muscular Dystrophy

A Phase 1b Study of SMT C1100 in Subjects With Duchenne Muscular Dystrophy (DMD)

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

The purpose of this study is to determine whether increasing doses of SMT C1100 are safe, well tolerated and achieve appropriate blood levels in patients with Duchenne Muscular Dystrophy (DMD).

NCT ID: NCT02056691 Completed - Colorectal Cancer Clinical Trials

EDICT - Exercise inDuced Changes In Colorectal Cancer Tissues

EDICT
Start date: October 2014
Phase: N/A
Study type: Interventional

This pilot study looks to explore the biological effects of exercise on cancer and muscle cells using a two week exercise program (HIThigh intensity training) on 20 patients with newly diagnosed and operable colorectal cancer following diagnosis and prior to surgery. Maximal oxygen uptake will also be measured. The aim of this pilot is to assess the feasibility of recruiting participants to and carrying out a two week preoperative exercise program in patients with colorectal cancer.

NCT ID: NCT02056184 Completed - Clinical trials for Rheumatoid Arthritis

Targeted Ultrasound in Rheumatoid Arthritis

TURA
Start date: December 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether therapy modifications (including addition of ultrasound-guided treatment change) can change imaging results in patients with early rheumatoid arthritis in a stable clinical disease activity state.