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NCT ID: NCT01881529 Completed - Diffuse Scleroderma Clinical Trials

A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma

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

To treat patients with scleroderma by blocking the expression of LOXL2. The investigators first need to confirm (through observation) that LOXL2 is overexpressed in disease.

NCT ID: NCT01881230 Completed - Breast Cancer Clinical Trials

Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)

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

The purpose of this study is to compare the safety and efficacy of nab-paclitaxel in combination with either gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line treatment in female subjects with triple negative metastatic breast cancer (TNMBC) or metastatic triple negative breast cancer.

NCT ID: NCT01880424 Completed - Clinical trials for Irritable Bowel Syndrome With Constipation (IBS-C)

A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

D5630C00001
Start date: July 2013
Phase: Phase 3
Study type: Interventional

This clinical trial is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo. Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be randomized at up to 60 trial centers in China, Australia, and New Zealand. The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12 weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment Period, patients meeting the entry criteria for this trial will be randomized to one of two double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).

NCT ID: NCT01879462 Completed - Clinical trials for Hepatitis C, Chronic

A First Time in Human Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single & Repeat Escalating Doses of GSK2878175 in Healthy Subjects

Start date: June 14, 2013
Phase: Phase 1
Study type: Interventional

GSK2878175 is a site IV NS5B non-nucleoside inhibitor (NNI) being developed for the treatment of chronic HCV infection. This study represents the first administration of GSK2878175 in humans to define safety, tolerability, and pharmacokinetics (PK) following single and repeat doses of GSK2878175 in healthy subjects. This is a Phase 1, randomized, single-blind, placebo-controlled, dose escalation study to determine the safety, tolerability, and PK profile of GSK2878175 in single (Part 1) and repeat doses (Part 2) in healthy subjects. In addition the study will explore the effect of a moderate (30%) fat meal on single dose PK endpoints in healthy subjects.

NCT ID: NCT01877915 Completed - Clinical trials for Coronary Artery Disease

A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure

COMMANDER HF
Start date: September 10, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared with placebo (inactive medication), in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure.

NCT ID: NCT01877668 Completed - Psoriatic Arthritis Clinical Trials

Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study

OPAL BROADEN
Start date: January 2014
Phase: Phase 3
Study type: Interventional

This is a 12 month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms, improving physical function and preserving bone structure in patients with active psoriatic arthritis and had inadequate response to a traditional, non-biologic disease modifying anti-rheumatic drug. Adalimumab is use as a comparator.

NCT ID: NCT01877655 Completed - Clinical trials for Cytomegalovirus (CMV)-Positive Recipients

A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)

HELIOS
Start date: September 11, 2013
Phase: Phase 3
Study type: Interventional

The purpose of the study was to evaluate the efficacy of ASP0113 compared with placebo as measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD) through 1 year post-transplant. Safety of ASP0113 in participants undergoing allogeneic HCT will also be evaluated.

NCT ID: NCT01876433 Completed - Clinical trials for Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

Beta 3 Agonist Treatment in Heart Failure

Beat-HF
Start date: September 30, 2013
Phase: Phase 2
Study type: Interventional

Objective: The objective of the study is to assess the structural and functional cardiac effects of treatment with the beta 3 AR agonist Mirabegron in patients with chronic heart failure. Design: The investigators are planning a study aiming at establishing proof of concept that treatment of patients with HF with Mirabegron has significant positive effects, as assessed by clinical and biochemistry measurements, but not by hard endpoints. The investigators are performing a combined dose-finding - chronic efficacy study. The study is a randomized, placebo-controlled, double-blinded trial. The follow-up period is 6 months. 70 patients with chronic heart failure will be included. Specific aims 1. Determine safety of administration of Mirabegron to patients with heart failure. 2. Determine if treatment with Mirabegron for 6 months induces beneficial cardiac structural remodelling in patients with heart failure. 3. Determine if Mirabegron improves symptoms and exercise capacity as indicated by questionnaires and 6 min walk test in patients with heart failure. 4. Determine effects of Mirabegron on cardiac conduction, repolarisation and rhythms and arrhythmias in patients with heart failure. 5. Determine effects of Mirabegron on circulating biomarkers in patients with heart failure.

NCT ID: NCT01876420 Completed - Aortic Stenosis Clinical Trials

The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study

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

To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.

NCT ID: NCT01874431 Completed - Clinical trials for Diabetic Nephropathies

Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy

ARTS-DN
Start date: June 12, 2013
Phase: Phase 2
Study type: Interventional

To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it was safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy. These treatment doses were compared to placebo.