Efficacy and Safety of TAK-491 in Grade 2 or 3 Essential Hypertension.

• Research type

  Research Study

• Full title

  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

• IRAS ID

  76074

• Contact name

  Mark Caulfield

• Sponsor organisation

  Takeda Global Research & Development Centre (Europe), Ltd.

• Eudract number

  2011-000220-16

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This phase 3, randomised, double-blind study is being funded by Takeda Global Research & Development Centre (Europe) Ltd (TGRD). The research aims to establish whether TAK-491, an oral drug that works by relaxing the blood vessels and reducing workload on the heart, alone or in combination with chlorthalidone (a diuretic agent), can control high blood pressure (known as hypertension) better in patients who have not reached their target blood pressure with TAK-491 alone. Angiotensin Receptor Blockers (ARBs) and angiotensin-converting enzyme (ACE) inhibitors are drugs that are widely used for the treatment of hypertension. They modulate the rennin-angiotensin-aldosterone system (RAAS), a system that results in relaxation or constriction of blood vessles. Drugs that control RAAS are used globally for the treatment of hypertension but many have side effects that limit their use. The study will assess both safety and efficacy of TAK-491 either with chlorthalidone or with a placebo in patients with grades 2 or 3 hypertension. Approximately 390-405 patients aged 18 or over will take part in this study and will be involved in the study up to 19 weeks which includes 14 weeks of study medication. During this time patients will be asked to take study medication daily and will be monitored regularly during 13 study visits. Patients will be required to provide blood and urine samples at intervals throughout the study to assess efficacy and monitor patient safety. The study will take place in approximately 130 sites in Europe.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  11/LO/1865

• Date of REC Opinion

  9 Feb 2012

• REC opinion

  Further Information Favourable Opinion