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NCT ID: NCT01764633 Completed - Dyslipidemia Clinical Trials

Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk

FOURIER
Start date: February 8, 2013
Phase: Phase 3
Study type: Interventional

The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.

NCT ID: NCT01763164 Completed - Clinical trials for Metastatic or Unresectable Cutaneous Melanoma

Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma

Start date: July 12, 2013
Phase: Phase 3
Study type: Interventional

Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61 mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be performed at a central laboratory. Only those patients with Q61 mutation per central laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0 versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This study will use an Interactive Response Technology (IRT). The primary end point of the study is progression-free survival. Key secondary end point is overall survival

NCT ID: NCT01755767 Completed - Clinical trials for Hepatocellular Carcinoma

Study of Tivantinib in Subjects With Inoperable Hepatocellular Carcinoma (HCC) Who Have Been Treated With One Prior Therapy

METIV-HCC
Start date: December 27, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if tivantinib (ARQ 197) is effective in treating patients with MET diagnostic-high hepatocellular carcinoma (liver cancer) who have already been treated once with another therapy.

NCT ID: NCT01755143 Completed - Cardiac Pacing Clinical Trials

Evaluation of Approved Pacing Lead (Model 5076) for Use in MRI Environment

Start date: December 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to test the safety and effectiveness of the Medtronic CapSureFix Novus Model 5076 lead when patients are implanted with the Medtronic Advisa MRI pacemaker and undergo an MRI scan.

NCT ID: NCT01753349 Completed - Cervical Dystonia Clinical Trials

Phase IV-Cervical Dystonia-INTEREST IN CD2

INTEREST_INCD2
Start date: December 2012
Phase:
Study type: Observational

The purpose of the study is to document long-term response in real-life practice after injection cycles with BoNT-A in subjects suffering from idiopathic cervical dystonia (Long-term clinical and pharmaco-economic data).

NCT ID: NCT01752140 Completed - Prostate Cancer Clinical Trials

A Prospective Randomized Trial of Prostate Biopsy Protocols Comparing the Vienna Nomogram and a Standard 10-core Biopsy Scheme

Start date: January 2009
Phase: N/A
Study type: Interventional

In this study, the investigators aim to determine if the Vienna nomogram increases the detection rate of TRUS-guided prostate biopsies by conducting a prospective randomized study comparing the Vienna nomogram with a 10-core biopsy protocol.

NCT ID: NCT01751126 Completed - Clinical trials for Vernal Keratoconjunctivitis

Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis

Start date: April 29, 2013
Phase: Phase 3
Study type: Interventional

The objective of this study is to compare the efficacy of two different dosing regimen of NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of the formulation) administered four times a day in patients with severe vernal keratoconjunctivitis after 4 months of treatment.

NCT ID: NCT01745263 Completed - Clinical trials for Improve Healthy Ageing in Seniors; Prevent Disease at Older Age

DO-HEALTH / Vitamin D3 - Omega3 - Home Exercise - Healthy Ageing and Longevity Trial

DO-HEALTH
Start date: December 20, 2012
Phase: Phase 3
Study type: Interventional

The European population is aging rapidly which poses a challenge on the individual, the European societies, and health care systems. Among the most promising public health interventions that may extend healthy life expectancy at older age are vitamin D, marine omega-3 fatty acids and physical exercise. However, their individual and combined effects have yet to be confirmed in a clinical trial. The broad aim of DO-HEALTH is to prolong healthy life expectancy in European seniors. The specific aim is to establish whether vitamin D, omega-3 fatty acids, and a simple home exercise program will prevent disease at older age. To achieve these aims, DO-HEALTH will enroll 2152 community-dwelling men and women who are 70 years and older, an age when chronic diseases increase substantially. The DO-HEALTH seniors will be recruited from 7 European cities (Zurich, Basel, Geneva, Toulouse, Berlin, Innsbruck and Coimbra) and will be randomized in a 2x2x2 factorial design trial to a simple home exercise program and/or vitamin D, and/or omega-3 fatty acids, over a 3 year period. This will allow to test the individual and the combined benefit of the interventions in the prevention of 5 primary endpoints: incident non-vertebral fractures; functional decline; systolic and diastolic blood pressure change; cognitive decline; and the rate of any infection. Key secondary endpoints include incidence of hip fractures, rate of falls, severity of pain in symptomatic knee osteoarthritis, gastro-intestinal symptoms, mental and oral health, quality of life, and mortality. All clinical endpoints will be supported by a large DO-HEALTH biomarker study to evaluate the effect of the interventions at the cellular level of multi-organ function. DO-HEALTH will further evaluate reasons why or why not seniors adhere to the 3 interventions, and will assess their cost-benefit in a health economic model based on documented health care utilization and observed incidence of chronic disease. website DO-HEALTH: http://do-health.eu/wordpress/

NCT ID: NCT01743989 Completed - Clinical trials for Philadelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.

ENESTPath
Start date: April 15, 2013
Phase: Phase 3
Study type: Interventional

This study aimed to assess the optimal duration of nilotinib 300 mg twice daily (BID) consolidation treatment in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), in order that patients remained in treatment-free remission (≥MR4.0) without molecular relapse 12 months after starting the Treatment-Free Remission (TFR) phase.

NCT ID: NCT01743001 Completed - Clinical trials for Pulmonary Arterial Hypertension

Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome

MAESTRO
Start date: May 21, 2013
Phase: Phase 3
Study type: Interventional

Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects with Eisenmenger Syndrome.