TAK-491CLD vs Olmesartan/HCTZ in patients with hypertension

• Research type

  Research Study

• Full title

  A Phase 3, Open-Label, Randomized, Long-Term Comparison of the Safety and Tolerability of the TAK-491 Plus Chlorthalidone Fixed-Dose Combination vs. Olmesartan Medoxomil-Hydrochlorothiazide Fixed-Dose Combination in Subjects With Essential Hypertension

• IRAS ID

  32195

• Contact name

  John Robinson

• Sponsor organisation

  Takeda Global Research & Development Centre (Europe) Ltd.

• Eudract number

  2008-008260-28

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  High Blood Pressure (Hypertension) is the most common cause of preventable death in developed nations. Uncontrolled hypertension greatly increases the risk of heart disease, brain disease, and kidney failure. As the population ages, the incidence of hypertension will continue to increase if effective preventive measures are not implemented. Despite the availability of antihypertensive agents, hypertension is not adequately controlled; only about one in three patients successfully keep blood pressure normal.This study will compare the safety and tolerability of TAK-491 plus chlorthalidone (TAK-491CLD) fixed-dose combination to olmesartan medoxomil-hydrochlorothiazide fixed-dose combination.To be eligible to take part in this trial amongst other factors, the patient must be willing to discontinue current antihypertensive medications on Day -14 to Day -1. The patient must be 18 or over and either treatment naive or who require a change to their current antihypertensive therapy. It is estimated that approximately 800-880 randomised patients will take part in this study. The study will be conducted in approximately 112 sites in United States, Canada and Europe.Initially patients will undergo a Screening Visit to confirm that they are eligible to participate in the study. All participants will receive the study drug for up to 52 weeks. The dose of the study drug may be gradually increased throughout the study so that a target blood pressure value can be reached for each participant.Throughout the treatment period of the study, participants will be required to visit the research site for 11 visits. At these study visits participants will be required to undergo certain study procedures including physical examinations, vital sign measurements (blood pressure, heart rate, weight and height), electrocardiograms (monitoring of the heart), and blood and urine samples taken for clinical laboratory tests.It is hoped the results form this study will help in the future treatment of patients with hypertension.

• REC name

  London - South East Research Ethics Committee

• REC reference

  09/H1102/109

• Date of REC Opinion

  21 Jan 2010

• REC opinion

  Further Information Favourable Opinion