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NCT ID: NCT02173275 Completed - Myocardial Ischemia Clinical Trials

Computed TomogRaphic Evaluation of Atherosclerotic DEtermiNants of Myocardial IsChEmia

CREDENCE
Start date: May 2014
Phase:
Study type: Observational

The study seeks to determine the accuracy of using anatomic and physiologic information measurable by computed tomography features of stenosis, plaque, fractional flow reserve-CT and to compare this measure to stress testing for the detection of myocardial ischemia against the gold standard of cardiac catheterization with fractional flow reserve. The hypothesis of this proposal is that integrating anatomic plaque features with physiologic fractional flow reserve-CT will optimize identification of coronary lesions that are ischemia-causing by computed tomography .

NCT ID: NCT02171429 Completed - Ulcerative Colitis Clinical Trials

A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors

HIBISCUS II
Start date: November 14, 2014
Phase: Phase 3
Study type: Interventional

This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active ulcerative colitis (UC) who are naIve to tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment. In addition to this study, a second Phase III trial with identical study design (GA28948; NCT02163759) was independently conducted.

NCT ID: NCT02163694 Completed - Clinical trials for Metastatic Breast Cancer

A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer

Start date: July 17, 2014
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2 (BRCA1; BRCA2) mutation in Human Epidermal Growth Factor Receptor 2 (HER2)-negative metastatic or locally advanced unresectable breast cancer. The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR) through the end of Week 24, objective response rate (ORR) and PFS on subsequent therapy (PFS2) in participants treated with veliparib in combination with C/P versus placebo in combination with C/P.

NCT ID: NCT02162667 Completed - Clinical trials for HER2-positive Carcinoma of Breast

Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer

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

This study will determine whether CT-P6 and Herceptin are equivalent in patients with early-stage breast cancer undergoing neoadjuvant chemotherapy. Our hypothesis is that the pathologic complete response rate will be equivalent in patients treated with neoadjuvant CT-P6 or Herceptin. Patients will receive 8 cycles of neoadjuvant systemic therapy and up to 10 cycles of therapy in the adjuvant setting.

NCT ID: NCT02151656 Completed - Schizophrenia Clinical Trials

F17464 in Acute Schizophrenia Trial

FAST
Start date: June 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the potential efficacy of oral F17464 in comparison to placebo over 6 weeks in patients with acute exacerbation of schizophrenia. Study design: double-blind, randomized, placebo-controlled, parallel-groups, fixed-dose design, multicentre study.

NCT ID: NCT02143583 Completed - Clinical trials for Birch Pollen Allergy

Follow-up of Study AN004T to Assess the Persistence of AllerT Efficacy During the 2nd to 4th Season After Treatment

Start date: February 2014
Phase: Phase 2
Study type: Observational

Study aiming to evaluate the efficacy of a 2-month pre-seasonal treatment with an AllerT 50 µg or 100 µg maintenance dose administered in previous study AN004T in reducing symptoms of allergic rhinoconjunctivitis during the 2nd following birch pollen season.

NCT ID: NCT02127970 Completed - Clinical trials for Surgical Site Infection

Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Start date: April 18, 2014
Phase: Phase 3
Study type: Interventional

To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in participants with known or suspected Gram-positive acute bacterial skin and skin structure infections (ABSSSI) at 48 -72 hours after initiation of treatment.

NCT ID: NCT02119494 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Phenotypes of COPD in Central and Eastern Europe

POPE
Start date: June 2014
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to assess the representation of COPD patients in terms of categories and phenotypes of the disease in selected countries in Central and Eastern Europe (CEE). The results of The POPE study will allow for evaluation of the differences in clinical approaches and treatment practices. The following countries are represented in The POPE study: Czech Republic, Slovakia, Austria, Poland, Hungary, Russia, Croatia, Serbia, Slovenia, Estonia, Latvia and Bulgaria.

NCT ID: NCT02111577 Completed - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer

VIABLE
Start date: May 26, 2014
Phase: Phase 3
Study type: Interventional

The VIABLE study sought to confirm the hypothesis that the combination of docetaxel with DCVAC/PCa followed by a maintenance therapy with DCVAC/PCa would improve overall survival in patients with metastatic castration-resistant prostate cancer.

NCT ID: NCT02111564 Completed - Heart Failure Clinical Trials

A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients

MARINER
Start date: January 7, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related death post-hospital discharge in high-risk, medically ill patients.