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NCT ID: NCT01960530 Completed - Clinical trials for Adrenal Insufficiency

An Investigational Study of Hydrocortisone

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

This study will investigate a new drug called Infacort®; a newly-developed immediate release formulation of a well-established drug called hydrocortisone. Hydrocortisone is used as a replacement treatment for people whose adrenal glands are not producing enough natural cortisol - a condition known as adrenal insufficiency. The study will assess how Infacort® acts once inside the body, by measuring cortisol and other hormone levels in the body, compared to already marketed hydrocortisone tablet and hydrocortisone intravenous (through the vein) injection. The population who are eligible to take part in the study are healthy male volunteers, aged between 18 and 60 years of age.

NCT ID: NCT01960374 Completed - Clinical trials for Healthy Volunteers Pharmacokinetic Study

Dose-escalation Study to Assess Selumetinib Safety, Tolerability and PK

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

The purpose of the study is to assess the safety, tolerability and PK of selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in healthy male Japanese and non-Japanese Asian volunteers following administration of a single dose. Standard safety assessments including ECGs, vital signs, blood/urine safety tests, PK samples and monitoring of adverse events and an optional exploratory pharmacogenetics will be performed.

NCT ID: NCT01960348 Completed - Clinical trials for Amyloidosis, Hereditary

APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis

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

The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in patients with transthyretin (TTR) mediated amyloidosis. An open-label, single-arm, long-term follow-up extension study NCT02510261 (ALN-TTR02-006) was initiated to provide participants who completed this study with continued patisiran-LNP (lipid nanoparticle) treatment.

NCT ID: NCT01960140 Completed - Healthy Volunteers Clinical Trials

A Study of Baricitinib and Simvastatin in Healthy Participants

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

The purposes of this study are to determine the effects of baricitinib on the time it takes to remove simvastatin from the body and to look at how well-tolerated and safe baricitinib is when given alone and in combination with simvastatin. Side effects will be documented. The study will last approximately 7 days from the first dose to the end of the study (not including screening or follow-up).

NCT ID: NCT01959529 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events

DEVOTE
Start date: October 29, 2013
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.

NCT ID: NCT01959516 Completed - COPD Clinical Trials

Effect of Glycopyrronium on Morning Symptoms and Pulmonary Function in Patients With Moderate to Severe COPD

Start date: February 2014
Phase: Phase 4
Study type: Interventional

This study purpose is to further study the profiles of glycopyrronium (NVA237) and tiotropium during the first hours after dosing and their impact on pulmonary function, COPD symptoms and ability to perform daily activities by the patient.

NCT ID: NCT01958645 Completed - Healthy Subjects Clinical Trials

To Assess Safety, Tolerability and Pharmacodynamics of Intravenous MEDI8111 After Single Ascending Doses.

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

A study to investigate the safety, tolerability and pharmacodynamics of MEDI8111 after single ascending doses in healthy male.

NCT ID: NCT01958619 Completed - Malaria Clinical Trials

Open Label Pharmacokinetic Study of OZ439 and Piperaquine on Administration of OZ439+TPGS Granules for Oral Suspension Alone or With Either Piperaquine Phosphate Tablets or Granules for Oral Solution in Healthy Volunteers

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

A healthy volunteer study to characterise the exposure of the two study medications, following administration of OZ439 + TPGS granules with piperaquine phosphate granules (intended for children) and with piperaquine phosphate tablets (intended for adults). Ideally, to confirm the exposure demonstrated in an earlier bioavailability study.

NCT ID: NCT01958489 Completed - Healthy Volunteers Clinical Trials

A Study of Evacetrapib in Japanese and Non-Japanese Participants

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

The main purpose of this study is to look at the effect of evacetrapib on pravastatin levels in the blood when both drugs are taken at the same time. The study will also assess how well the body handles evacetrapib and pravastatin when given at the same time. This study has two periods in fixed order. Each participant will enroll in both periods. This study will last approximately 25 days, not including screening.

NCT ID: NCT01958320 Completed - Surgery Clinical Trials

Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus

PDA:TOLERATE
Start date: December 2013
Phase: Phase 2
Study type: Interventional

The primary goal of the trial is to compare two different Patent Ductus Arteriosus (PDA) treatment approaches: 1) an "early treatment" approach or 2) a "conservative" approach. For the purposes of the study infants will be enrolled if they are delivered before 28 weeks gestation and have a moderate/large PDA present at 5-7 days after birth. The hypothesis is: treatment of a moderate size patent ductus arteriosus (PDA) will decrease the time needed for assisted respiratory support, diuretic therapy, and gavage feeding assistance, in addition to decreasing the incidence of ductus ligations or need for future outpatient cardiology follow-up appointments. The investigators hypothesize that one or more of these benefits will occur without an increase in the time taken to achieve full enteral feedings or in the incidence of necrotizing enterocolitis (NEC) or spontaneous intestinal perforations (SIP).The investigators will be comparing the effectiveness of early pharmacologic treatment with a control group of conservatively managed infants who will only receive treatment if they meet specific criteria for "rescue treatment".