Willem J. Remme
Pat Illingworth
Karen Keukelaar
Jan A. de Witt
Karen J. Williams
Ralph Hultzer
Dori Kadmon
Regulatory Affairs
Clinical Monitoring
Pharmacovigilance
Clinical Event Management
Medical Review
Medical Writing
Landmark Trials
Scientific Advisory Board
Biography Dr Williams
Team Expertise
 
 

Landmark Trials

Sticares InterACT, a full service CRO operating globally with a profound scientific background, is able to design, manage and execute the most complex trials. We have a long tradition in cardiovascular and metabolic trials and we have successfully managed several multinational landmark trials.

 

CHF CAD POST-MI ATHEROSCLEROSIS DIABETES HYPERTENSION

Sticares InterACT manages acute and chronic heart failure trials on both investigational drugs and devices. We also prepare, coordinate and carry out heart failure surveys.

Our multinational endeavors include:

SHIFT

Systolic heart failure treatment with the If inhibitor ivabradine trial



SHAPE survey           

Study of heart failure awareness and perception in 9 countries representing Northern, Central, Southern and Western Europe.

CANCION device study        

Study of the Cancion - Cardiac Recovery System (CRS) for the use of treatment of acute decompensated heart failure

 


OLMEBNP

Non-inferiority study to assess the efficacy and safety of olmesartan medoxomil versus candesartan cilexetil in patients with symptomatic heart failure.

 

GAPS-HF

GAPS-HF is a global survey of medical specialist management of chronic heart failure and is coordinated by the Sticares Research Foundation. A similar survey, called SHAPE, is completed in Western countries while the GAPS-HF study concentrates on developing countries. The aim of the study is to describe the diagnosis, different forms of care and the treatment of heart failure across a wide variety of countries by cardiologists and other specialists who manage heart failure patients.

Results of landmark trials are published in international peer-reviewed journals such as the European Heart Journal, The Lancet and Circulation.

Our landmark trials on coronary artery disease include:

EUROPA         

European trial on reduction of cardiac events with perindopril in stable coronary artery disease





BEAUTIFUL   

Morbidity-mortality evaluation of the If inhibitor ivabradine in patients with coronary disease and left ventricular dysfunction





SIGNIFY        

Study assessing the morbidity-mortality benefits of the If inhibitor ivabradine in patients with coronary artery disease



 

Our trials on myocardial infarction include:

PREAMI

Perindopril and remodeling in elderly with acute myocardial infarction

 

 

 

Our trials on atherosclerosis include:

PERSPECTIVE

Perindopril’s prospective effect on coronary atherosclerosis by angiography and intravascular ultrasound evaluation

 

PERFECT

Perindopril-function of the endothelium in coronary artery disease trial: the PERFECT sub-study of EUROPA

Our trials on diabetes include:

PERSUADE

Perindopril substudy in coronary artery disease and diabetes: the Diabetic substudy of EUROPA

Our trials on hypertension include:

HYVET

Hypertension in the very elderly trial with perindopril / indapamide

 

Perindopril-005

Effect of once-a-day oral administration at bedtime of a delayed release formulation of perindopril on safety and blood pressure in hypertensive adult patients

 

ADDING & M-ADDING

Evaluation of the efficacy and tolerability of the fixed combination of manidipine and delapril in hypertensive patients non responsive to treatment with manidipine alone

 

PREMIUM

Study of the efficacy and safety of perindopril/amlodipine combinations, including a comparison with an irbesatan/hydrochlorothiazide combination in mild to moderate hypertension

 
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