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NCT ID: NCT02053038 Active, not recruiting - Clinical trials for Coronary Artery Disease

Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation

DEFINE-FLAIR
Start date: January 2014
Phase: N/A
Study type: Interventional

Narrowing of coronary arteries interferes with blood flow and can cause chest pain. But patients may have more than one narrowing and studies have shown that not all narrowings need to be treated. To identify the narrowings that need treating cardiologists sometimes quantify the extent of the narrowing by measuring fractional flow reserve (FFR, the ratio of the pressure in the aorta to the pressure downstream of the narrowing).This technique requires the administration of drugs that add cost and time to the procedure and in some countries are simply unavailable. As a result despite the clear health and healthcare costs benefits of FFR its use is limited to less than 5% of procedure. We have developed a new technique called the instantaneous wave-free ratio (iFR) that does not require the administration of drugs for its accurate assessment. It has been approved for use in this indication. This study aims to compare clinical outcomes of patients whose treatment has been guided by iFR to those whose treatment has been guided by FFR. If iFR is found to provide the same clinical outcomes as FFR its adoption will permit the clear benefits of this approach of identifying the coronary narrowings that really need treatment to be applicable to a much larger patient population and further improve healthcare costs.

NCT ID: NCT02052778 Completed - Breast Cancer Clinical Trials

A Study of TAS-120 in Patients With Advanced Solid Tumors

Start date: July 21, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, nonrandomized, Phase 1/2 study for the fibroblast growth factor receptor (FGFR) inhibitor futibatinib (TAS-120). The purpose of the study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, and anti-tumor activity of futibatinib in patients with advanced solid tumors with and without genomic FGF/FGFR abnormalities. The study will be conducted in 3 parts: 1. Dose escalation portion to determine the -Maximum Tolerated Dose and/ or Recommended Phase 2 Dose of futibatinib. 2. Phase 1 expansion portion to further evaluate the safety and efficacy of futibatinib in patients with tumors harboring FGF/FGFR aberrations, including patients with cholangiocarcinoma (CCA), primary central nervous system tumors, urothelial carcinoma, breast cancer, gastric cancer. 3. Phase 2 study portion to confirm objective response rate of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).

NCT ID: NCT02052609 Completed - Psoriatic Arthritis Clinical Trials

A Phase 3 Clinical Study of KHK 4827

Start date: February 2014
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the safety and efficacy of long-term exposure to KHK4827 in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic erythroderma) who have completed Study 4827-003 (Study 003)and in subjects with pustular psoriasis (generalized) or psoriatic erythroderma who have completed the Study 4827-004 (Study 004).

NCT ID: NCT02051608 Completed - Alzheimer's Disease Clinical Trials

A Study of Gantenerumab in Participants With Mild Alzheimer Disease

Start date: March 27, 2014
Phase: Phase 3
Study type: Interventional

Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer disease. Participants will be randomized to receive either gantenerumab subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE). A positron emission tomography (PET) imaging substudy will be conducted within the main study. Eligible participants who provide separate informed consent will undergo PET imaging scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain amyloid load over time.

NCT ID: NCT02050555 Completed - Overweight Clinical Trials

Anti-obesity Effect of Koji-extracted Beverage Fermented With Pediococcus Pentosaceus LP28

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

This study is designed to evaluate the effect of koji-extracted beverage fermented with Pediococcus pentosaceus LP28 on BMI and body fat in overweight subjects.

NCT ID: NCT02047890 Completed - Neoplasms Clinical Trials

Japanese BAY1000394 Monotherapy Phase I Study

Start date: May 19, 2014
Phase: Phase 1
Study type: Interventional

This is an open-label, non-randomized, dose-escalating Phase I study to evaluate the safety, tolerability, pharmacokinetics of BAY1000394 given in a 3 days on / 4 days off schedule in Japanese subjects with advanced malignancies.

NCT ID: NCT02046564 Completed - Clinical trials for Major Depressive Disorder

Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder

Start date: February 2014
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and the safety of ASC-01 (aripiprazole/sertraline combination) compared to sertraline monotherapy in patients with major depressive disorders who have responded incompletely to sertraline monotherapy.

NCT ID: NCT02043678 Completed - Prostatic Neoplasms Clinical Trials

Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms

ERA 223
Start date: March 30, 2014
Phase: Phase 3
Study type: Interventional

To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.

NCT ID: NCT02043288 Completed - Clinical trials for Pancreatic Neoplasms

Combination Therapy With NC-6004 and Gemcitabine Versus Gemcitabine Alone in Pancreatic Cancer

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

This clinical trial is designed to evaluate the impact of the addition of NC-6004 to gemcitabine in the treatment of patients with locally advanced or metastatic pancreatic cancer in Asian countries.

NCT ID: NCT02042911 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Efficacy and Safety Study of SyB L-0501 for Patients With Chronic Lymphocytic Leukemia

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

The purpose of this study is to investigate safety and efficacy of SyB L-0501 after 2-day intravenous infusion at a dose of 100 mg/m2/day to patients with chronic lymphocytic leukemia.