To Compare Eprosartan and Eprosartan Mesylate in hypertension-M13-385

• Research type

  Research Study

• Full title

  A Prospective, Randomized, Double-Blind, Parallel-Group Study to Compare the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Subjects with Essential Hypertension

• IRAS ID

  101058

• Contact name

  John Robinson

• Sponsor organisation

  Abbott Products GmbH

• Eudract number

  2010-019155-22

• ISRCTN Number

  zz

• Research summary

  This phase III Study M13-385 is designed to compare the effect of eprosartan 450 mg and eprosartan mesylate equivalent to eprosartan 600 mg on blood pressure and on safety in subjects with mild to moderate essential hypertension (high blood pressure). Eprosartan is a non-peptide angiotensin type 1 receptor antagonist indicated in essential hypertension. Eprosartan is marketed as a mesylate salt in the form of 600 mg eprosartan tablet (Teveten©, 600 mg and the 600/12.5 mg eprosartan/ hydrochlorothiazide (HCTZ) tablet (Teveten© Plus). Due to the large size of the currently available Teveten© (eprosartan mesylate) tablet, the development of a new formulation was initiated with the aim to reduce the tablet size to ensure that the tablet size becomes more acceptable. Due to the increased bioavailability of eprosartan, it is possible to reduce the active pharmaceutical ingredient (API) by about 40% (percentage mass) and consequently tablet size by about 30% (percentage mass). Subjects will be in the study for a total of 15 weeks, which include 3 weeks of single-blind placebo wash-out (subjects receiving two or less antihypertensive medications will be required to discontinue their current medication) and then 12 weeks of double-blind active treatment.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  12/LO/0481

• Date of REC Opinion

  15 May 2012

• REC opinion

  Further Information Favourable Opinion