Aliskiren vs telmisartan in mild to moderate hypertension

• Research type

  Research Study

• Full title

  A twelve-week, randomized, double-blind, parallel group study to evaluate the prolonged efficacy and safety of aliskiren 300 mg compared to telmisartan 80 mg in mild to moderate hypertensive patients with 24-hour ambulatory blood pressure measurement after 1 week of treatment withdrawal

• IRAS ID

  19910

• Eudract number

  2008-007831-41

• ISRCTN Number

  0000000000000

• Clinicaltrials.gov Identifier

  0000000000000

• Research summary

  Hypertension (high blood pressure) affects approximately one billion people worldwide, and is a major risk factor for stroke, coronary heart disease and other illnesses such as kidney disease.Poor compliance during antihypertensive treatment is one of the main causes of unsatisfactory blood pressure control and might lead to increased cardiovascular risk.The aim of this study is to investigate and compare the blood pressure lowering effect of two anti-hypertensive medicines, aliskiren and telmisartan, taken for a 12-week period in patients with mild to moderate hypertension. Treatment will then be stopped for 7 consecutive days and the resulting effect on blood pressure control will be measured.Eligible patients who have provided written agreement to take part in the study will be randomly allocated to receive treatment with either aliskiren (starting at 150mg daily and titrating up to 300mg daily) or telmisartan (starting at 40mg daily and titrating up to 80mg daily). There will be an equal chance of receiving either medication.Each patient will visit the clinic up to 10 times over a 14 - 17 week period. There will be a wash-out period where the patient will take no hypertensive medication for up to 2 weeks. After this there will be a placebo (dummy treatment) run-in period which will last up to 2 weeks, followed by 12 weeks of double-blind treatment (neither the patient nor the doctor will know which of the two treatments they have been allocated). At the end of the treatment period the active medication will be stopped for 7 days (patients will take placebo during this period).The main assessment will be 24-hour ambulatory blood pressure measurement using an automated device attached to the patient at three timepoints: at Visit 2 (baseline), Visit 6 (after 12 weeks of active treatment) and Visit 8 (after 7 days of treatment withdrawal).

• REC name

  Wales REC 3

• REC reference

  09/MRE09/26

• Date of REC Opinion

  29 May 2009

• REC opinion

  Further Information Favourable Opinion