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NCT ID: NCT01836146 Completed - Hypertension Clinical Trials

International First-in-Human Study of the EnligHTN Generation 2 System in Patients With Drug-resistant Uncontrolled Hypertension

EnligHTN III
Start date: April 2013
Phase: N/A
Study type: Interventional

The purpose of this First-in-Human Clinical investigation is to evaluate the safety and performance of the St. Jude Medical EnligHTN™ Generation 2 Renal Denervation System for the treatment of patients with drug-resistant uncontrolled hypertension.

NCT ID: NCT01830621 Completed - Clinical trials for Colorectal Carcinoma

BBI608 and Best Supportive Care vs Placebo and Best Supportive Care in Pretreated Advanced Colorectal Carcinoma

Start date: May 10, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to find out whether it is better to receive a new drug, BBI608, or better to receive no further treatment for colon or rectal cancer. To do this, half of the patients in this study will get BBI608 and the other half will receive a placebo (a substance that is designed not to do anything).

NCT ID: NCT01830543 Completed - Atrial Fibrillation Clinical Trials

A Study Exploring Two Strategies of Rivaroxaban (JNJ39039039; BAY-59-7939) and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention

PIONEER AF-PCI
Start date: May 10, 2013
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various combinations of dual antiplatelet therapy (DAPT) or low-dose aspirin (ASA) or clopidogrel (or prasugrel or ticagrelor).

NCT ID: NCT01829295 Completed - Uveitis Clinical Trials

Methotrexate and Mycophenolate Mofetil for UVEITIS

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

In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial, the investigators propose to establish which immunosuppressive therapy, methotrexate or mycophenolate mofetil, is more effective as a first-line, corticosteroid-sparing agent for the treatment of non-infectious uveitis in a block-randomized, observer-masked, comparative effectiveness trial.

NCT ID: NCT01828099 Completed - Clinical trials for Non-Small Cell Lung Cancer

LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer

Start date: July 9, 2013
Phase: Phase 3
Study type: Interventional

The primary purpose of the study was to compare the antitumor activity of LDK378 versus reference chemotherapy. Patients in the chemotherapy arm were given the option to switch to LDK378 after confirmed progressive disease (PD), while also had the choice to continue with pemetrexed treatment.

NCT ID: NCT01827644 Completed - Cancer Clinical Trials

Bioavailability and Food Effect of the Original Gelatin Formulation and Two New Formulations of Afuresertib in Normal Healthy Volunteers

Start date: April 24, 2013
Phase: Phase 1
Study type: Interventional

This will be a randomized, open-label, sequential, single dose, 4-period crossover study. This study is being conducted to measure the relative bioavailability of the original gelatin capsule (GC) formulation and two new formulations (hydroxypropyl-methylcellulose [HPMC] capsule and enteric coated tablet [ECT]) of afuresertib (AFU), in the fed and fasted state. The study will be composed of Screening, Treatment, and Follow-up Periods. Screening assessments to determine subject eligibility will be performed within 3 weeks prior to the first dose of study drug in the Treatment Period. Eligible subjects will be randomized to receive 4 of the 6 possible study treatments (A: AFU GC administered in a fasted state, B: AFU GC administered in a fed state, C: AFU HPMC capsule administered in a fasted state, D: AFU HPMC capsule administered in a fed state, E: AFU ECT administered in a fasted state, F: AFU ECT administered in a fed state) in 4 treatment periods (one per treatment period). Subjects will receive a single dose of one of the six study treatments (A, B, C, D, E, F) on Day 1 of each Dosing Period, according to one of the 6 treatment sequences (CEDA, EFAB, ABFC, BDCE, FCBD, DAEF). There will be a minimum of 10 Day washout period between the doses administered in each Treatment Period. A Follow-up visit will be conducted within 10-14 days after the last dose. A subject's total time involved in the study will be approximately 9 weeks. At least 36 subjects will be enrolled in the study, to ensure that at least 6 subjects will be randomized to receive each treatment sequence.

NCT ID: NCT01827046 Completed - Clinical trials for Intracerebral Hemorrhage

Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III

MISTIE-III
Start date: December 30, 2013
Phase: Phase 3
Study type: Interventional

A phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH).

NCT ID: NCT01826513 Completed - Clinical trials for Obstructive Sleep Apnea

AutoSet for Her Clinical Trial Protocol

Start date: May 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the efficacy and user preference of the Newport AutoSet for Her in female obstructive sleep apnea (OSA) patients. Efficacy will be evaluated by comparing the apnea and hypopnea index (AHI) and oxygen desaturation index (ODI) of the Newport AutoSet for Her algorithm to a standard algorithm. User preference will be evaluated by subjective feedback relating to comfort, ease of falling asleep, sleep disturbance and feeling of being refreshed.

NCT ID: NCT01826487 Completed - Clinical trials for Nervous System Diseases

Phase 3 Study of Ataluren in Participants With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD)

ACT DMD
Start date: March 26, 2013
Phase: Phase 3
Study type: Interventional

Dystrophinopathy is a disease continuum that includes Duchenne muscular dystrophy, which develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability. A specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of dystrophinopathy in approximately 10-15 percent (%) of boys with the disease. Ataluren is an orally delivered, investigational drug that has the potential to overcome the effects of the nonsense mutation. The main goal of this Phase 3 study is to evaluate the effect of ataluren on walking ability. The effect of ataluren on physical function, quality of life, and activities of daily living will be evaluated. This study will also provide additional information on the long-term safety of ataluren.

NCT ID: NCT01826214 Completed - Acute Leukemias Clinical Trials

Study of Efficacy and Safety of LDE225 in Adult Patients With Relapsed/Refractory Acute Leukemia

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

The study will evaluate the efficacy, safety and tolerability of two dosing schedules of LDE225 in patients with relapsed/refractory acute leukemia or elderly patients with untreated acute leukemia.