DISTINCT

• Research type

  Research Study

• Full title

  A Multicenter, Multifactorial, Randomized, Double-Blind, Placebo-Controlled Dose- Finding Study of Nifedipine GITS and Candesartan in Combination Compared to Monotherapy in Adult Patients with Essential Hypertension

• IRAS ID

  55012

• Contact name

  Peter Harvey

• Sponsor organisation

  Bayer HealthCare AG

• Eudract number

  2009-017077-37

• ISRCTN Number

  na

• Research summary

  Worldwide, hypertension is a leading risk factor for morbidity and mortality, and relates largely to the risk of development of cardiovascular diseases. Many studies have shown control blood pressure (BP) can reduce cardiovascular morbidity and mortality. Unfortunately in practice few patients achieve their recommended BP goals. Current guidelines suggest the use of combination therapy with different agents to control; BP rather than up-titrated monotherapy.This placebo controlled phase II study plans to recruit adult patients with mild to moderate essential hypertension as measured by a calibrated electronic BP measuring device. Patients must have an absolute difference in their mean seated diastolic BP of less than 10mmHg between the run-in phase and randomization visit. 1320 patients will be randomized to one of 16 treatment groups in an equal ration. The sixteen treatment group will consist of placebo treatment, Nifedipine GITS monotherapy (at varying does), Candesartan monotherapy (at varying doses) or Nifedipine GITS/Candesartan combination therapy (at varying doses). Patients will be on study for 14 to 16 weeks (which includes a washout period where patients will discontinue or taper down current antihypertensive treatments, followed by single blind run-in period, and finally an 8-week treatment double-blind treatment period).The primary objective is to determine the dose-response of the various combinations of Nifedipine GITS and Candesartan as compared to monotherapy and placebo based on the BP lowering effects of a once-daily regimen in patients with World HealthOrganization classification Grades 1 and 2 essential hypertension.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  11/SC/0127

• Date of REC Opinion

  23 May 2011

• REC opinion

  Further Information Favourable Opinion