Success story in Cardiology

Hypertension is one of the major and well known risk factors for Heart diseases and circulatory system, which are the main causes of death in Europe. The World Health Organisation Report on 2002 estimates that around 11% of all diseases burden in developed countries is caused by high blood pressure, and that over 50% of coronary heart diseases (CHD) and almost 75% of strokes in developed countries is due to high blood pressure.

 

Arterial hypertension affects approximately 20–25% of adult people. In Russia the occurrence of this disease amounts to 39,1% in men and 41,1% in women.

 

ESMAR has been involved in the hypertension studies, working from the feasibility assessment to the study close-out phase.

 

Therapeutic area: mild or moderate hypertension
Study sponsored by: a leading European pharmaceutical company
Study description: the study course consisted of a two-weeks single blind wash-out/run-in period and  four-weeks single blind treatment period followed by a double blind randomized treatment for 12 weeks.
Study design: phase III; double blind, randomized, controlled, parallel group, multicenter study
Number of involved countries: 5
Client goal: to immediately accelerate enrollment, recruiting 100 additional patients during one month
Challenge: complex protocol
Number of sites in Ukraine: 8 sites
Planned randomized patients in Ukraine: 100 patients

 

Results:

  1. Enrollment was ahead of schedule, recruiting 100 patients in only 25 working days.
  2. The recruitment rate was considerably higher than expected. 8 sites enrolled 89 patients during only three weeks.

 

 

 

The sponsor noted the high quality in ESMAR’s CRAs work and the professionality of our team!