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INTERVENTIONAL MANAGEMENT OF STROKE TRIAL CLINICAL PROTOCOL - IMS III
A phase III, randomized, multi-center, open label, 900 subject clinical trial that will examine whether a combined intravenous (IV) and intra-arterial (IA) approach to recanalization is superior to standard IV rt-PA (Activase®/Actilyse®) alone when initiated within three hours of acute ischemic stroke onset.

The primary objective of the trial is to determine if ischemic stroke subjects with a baseline NIH Stroke Scale Score (NIHSSS] >= 10 (8-9 with positive CTA) treated with recombinant tissue plasminogen activator (rt-PA; [Alteplase recombinant…

Protocol I1V-MC-EIAN Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition with Evacetrapib in Patients at a High-Risk for Vascular Outcomes - the ACCELERATE Study

The primary objective of this study is to test the hypothesis that evacetrapib 130 mg daily, in comparison to placebo, reduces the incidence of the composite endpoint of cardiovascular (CV) death, myocardial infarction (MI), stroke, coronary…

Clinical effectiveness of standard versus pathogen-reduced buffy coat-derived platelet concentrates in plasma in hemato-oncological patients;Pathogen Reduction Evaluation & Predictive Analytical Rating Score (The PREPAReS Study)

A prospective randomized phase III clinical trial to study the effectiveness of pathogen-reduced platelet concentrates in plasma, stored for up to 7 days, and compare these with untrested platelet concentrates in plasma, stored for up to 7 days. The…

TropicALL study; Thromboprophylaxis in Children treated for Acute Lymphoblastic Leukemia with
Low-molecular-weight heparin: a randomized controlled trial

Main objective:To assess the efficacy of thromboprophylaxis with high prophylactic dose LMWH as compared with standard care without systemic thromboprophylaxis in children treated for primary ALL during asparaginase treatment.Secondary objectives:1…

A prospective Randomised, open label, blinded endpoint (PROBE) study to Evaluate DUAL antithrombotic therapy with dabigatran etexilate (110mg and 150mg b.i.d.) plus clopidogrel or ticagrelor vs. triple therapy strategy with warfarin (INR 2.0 - 3.0) plus clopidogrel or ticagrelor and aspirin in patients with non valvular atrial fibrillation (NVAF) that have undergone a percutaneous coronary intervention (PCI) with stenting

See section 2.2 of the protocol.The main objective of this study is to compare a DAT regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg DE-DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (…

A randomised controlled multicenter trial comparing ultrasound-accelerated catheter-directed thrombolysis combined with standard anticoagulant therapy versus standard anticoagulant therapy alone for acute primary iliofemoral deep vein thrombosis (IFDVT).

Primary Objective: Can catheter directed thrombolytic therapy, for the treatment of primary IFDVT, safely and effectively reduce post thrombotic morbidity after one year?Secondary Objective: Does catheter directed thrombolytic intervention have a…

Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732 and LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients with Heterozygous Familial Hypercholesterolemia

Primary objective* To assess the long-term safety of alirocumab when added to currently available lipid-modifying drug therapy in patients with heterozygous familial hypercholesterolemia (heFH) who have completed one of the following studies:…

A Phase 3b, prospective, randomized, open-label, blind evaluator (PROBE) study evaluating the efficacy and safety of LMWheparin/edoxaban versus dalteparin in venous thromboembolism associated with cancer

The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH compared with dalteparin for theprevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects…

Pre-emptive, OCT guided angioplasty of vulnerable, intermediate coronary lesions: a randomized trial

To determine the effect of the stenting of intermediate, vulnerable coronary lesions on the prevention of future ACS, in patients with residual non-obstructive CAD after PCI for myocardial infarction.

A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy

To assess the effect of oral UT-15C with PAH-approved oral monotherapy compared to placebo with PAHapproved oral monotherapy on time to first clinical worsening event (adjudicated), as defined by at least one of the events listed below:- Death (all…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled,
Parallel Group Study to Evaluate the Efficacy and Safety of
Sirukumab in the Treatment of Patients with Giant Cell Arteritis

Part A: 52-week double-blind treatment phasePrimary* To investigate the efficacy of sirukumab (100 mg q2w for 12 months) as compared to placebo, each administered in addition to a 6-month prednisone treatment regimen Secondary* To assess cumulative…

UMPIRE - Use of a Multidrug Pill In Reducing cv Events - a randomised controlled trial of fixed dose combination medication and usual care in those at high risk of cardiovascular disease.

To assess whether provision of the Red Heart polypill (containing low dose aspirin, a statin and two blood pressure lowering medicines) compared to usual cardiovascular medications improves adherence to indicated medicines and clinical outcomes in…

A Placebo-controlled, Double-blind, Randomised, Parallel-group, Long-term Phase III Trial Assessing the Safety and Efficacy of 50 microgram and 100 mircrogram/day of eprotirome in Patients with Heterozygous Familial Hypercholesterolaemia who are on Optimal Standard of Care

The primary objective of this study is to compare the efficacy of eprotirome 50 microgram and eprotirome 100 micorgram versus placebo in terms of the percent change in LDL-C from baseline to Week 12 in HeFH patients with CAD, or who are at high risk…

A 2x2 Factorial, Randomized, Multicenter, Single-Blind Evaluation of Intracoronary Abciximab Infusion and Aspiration Thrombectomy in Patients Undergoing Percutaneous Coronary Intervention for Anterior ST-Segment Elevation Myocardial Infarction

The primary objective of the study is to demonstrate that among subjects undergoing primary PCI for anterior STEMI treated with a bivalirudin monotherapy anticoagulation strategy, the intracoronary infusion of an abciximab bolus with or without…

A Phase-3 Randomized, Double-Blind, Efficacy and Safety Study Evaluating the Fixed Dose
Combinations of TAK-491 Plus Chlorthalidone (40/12.5 mg and 40/25 mg) in Subjects With
Grades 2 or 3 Essential Hypertension, Who Do Not Achieve Target Blood Pressure
Following Treatment With TAK-491 40 mg Monotherapy.

The objective of this phase-3 randomized study, with a double-blind treatment period of 8 weeksduration is to evaluate the efficacy and safety of the fixed dose combinations of TAK-491 pluschlorthalidone (40/12.5 mg and 40/25 mg) in subjects with…

A RANDOMISED, DOUBLE-BLIND, ADD-ON STUDY OF HYDROCHLOROTHIAZIDE IN SUBJECTS WITH MODERATE TO SEVERE HYPERTENSION NOT ACHIEVING TARGET BLOOD PRESSURE ON OLMESARTAN MEDOXOMIL/AMLODIPINE FIXED DOSE COMBINATION 40/10 MG ALONE

Primary: Period II (Week 8 to Week 16)1. To demonstrate the additional antihypertensive efficacy for seated diastolic blood pressure (SeDBP) gained by adding HCTZ 12.5 or 25 mg to the treatment regimen in subjects with moderate to severe HTN not…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With a History of Atherosclerotic Disease: Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2*P - TIMI 50)

Objectives:The following objectives are designed to address the effects of SCH 530348 when administered orally in addition to the standard of care for a minimum of 1 year in subjects with documented atherosclerotic disease.Primary Objective: The…

Safety of oral chronic administration of ivabradine modified release formulation compared to ivabradine immediate release formulation, in patients with stable coronary artery disease. A 6 to 12-month randomised double blind parallel groups multicentre study.

The purpose of this study is to assess the safety of the new modified release (MR) formulation of ivabradine administered orally, at titrated doses if necessary, in patients with stable coronary artery disease (CAD) with or without angina pectoris.

A RANDOMISED, DOUBLE-BLIND, PARALLEL-GROUP STUDY EVALUATING THE EFFICACY AND SAFETY OF CO-ADMINISTRATION OF TRIPLE COMBINATIONS OF OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE, AND HYDROCHLOROTHIAZIDE COMPARED WITH THE CORRESPONDING OLMESARTAN-AMLODIPINE COMBINATION IN SUBJECTS WITH HYPERTENSION

Primary Objective1. The main objective of this study is to demonstrate that OM/AML/HCTZ triple combinations are more efficacious in lowering SeDBP than corresponding dual combinations of OM/AML after 10 weeks of double blind treatment.Secondary…

Ptcl-01373 - A double blind, randomized, placebo-controlled, parallel group, multicenter Phase 3 pivotal study to assess the safety and efficacy of 1mg/kg/day intravenous DP-b99 over 4 consecutive days versus placebo when initiated within nine hours of acute ischemic stroke onset

"The primary objective of this study is to compare the clinical therapeutic effects of intravenous DP-b99 at adose of 1.0 mg/kg initiated within nine hours of stroke onset and administered daily over 2 hours for 4consecutive days versus placebo…