Monotherapy vs Dual Therapy for Initial Treatment for hypertension

• Research type

  Research Study

• Full title

  Monotherapy vs Dual Therapy for Initial Treatment for hypertension

• IRAS ID

  24155

• Contact name

  Morris Brown

• Sponsor organisation

  Cambridge University Hospitals NHS Foundation Trust

• Eudract number

  2008-007749-29

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Current practice in hypertension management uses a stepped care approach. Initial monotherapy is added to, according to the results of subsequent blood pressure measurement. However, attempting to lower blood pressure by pharmacological means triggers adaptive responses in the patient that counteract the induced hypotension. Our hypothesis is that these adaptations, if triggered in the early stages of hypertension treatment, impair further attempts to achieve target blood pressure levels. Consequently a significant proportion of patients become resistant to treatment, seen as the failure to achieve target blood pressure levels or as a requirement for increased amounts of medication to get to target. This study tests whether initial combination therapy with two drugs that are complementary in action is superior to the current stepped-care approach. Confirmation that patients starting on one drug Ó?never catch up? with patients starting on two drug therapy would have a major impact on hypertension treatment practice; possibly more than any previous study in hypertension. The study is a prospective, multicentre, double-blind, active-controlled trial in patients with essential hypertension. Patients studied will either be newly diagnosed with hypertension (50%) or will be known hypertensives who have previously received only monotherapy treatment (50%). There will be three phases in the trial: Phase 1: Randomised, parallel-group, double-blind assignation to two arms: combination or monotherapy Phase 2: Open-label: all patients receive combination therapy with two drugs Phase 3: Open label plus single-blind extension: patients receive two-drug combination plus either a third drug or placebo, as dictated by whether BP is above or below target.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  09/H0308/132

• Date of REC Opinion

  27 Aug 2009

• REC opinion

  Further Information Favourable Opinion