Aliskiren vs valsartan, blunting of exercise-induced hypertension v1

• Research type

  Research Study

• Full title

  An eight-week, randomized, double-blind, parallel-group, pilot study to evaluate the efficacy and safety of aliskiren 300 mg in comparison with valsartan 320 mg in patients with mild to moderate hypertension during exercise after a missed dose

• IRAS ID

  10841

• Contact name

  Bryan Williams

• Sponsor organisation

  Novartis Pharmaceuticals Services AG

• Eudract number

  2008-005500-10

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• 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.In hypertensive patients who exercise regularly, it is important to evaluate the effect of their treatment at rest as well as during exercise, as physical activity can cause increased stress on the cardiovascular system (the heart and the blood vessels). The aim of this study is to investigate and compare the blood pressure lowering effect of two anti-hypertensive medicines, aliskiren and valsartan, during exercise in patients with mild to moderate hypertension. It will also determine the effect of stopping treatment for 1 day on these patients' ability to exercise.Eligible patients will be randomly allocated to receive treatment with either aliskiren (starting at 150mg daily and titrated up to 300mg daily) or valsartan (starting at 160mg daily and titrated up to 320mg daily). There will be an equal chance of receiving either medication.Each patient will visit the clinic up to 8 times over a 12-13 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 single-blind placebo (dummy treatment) run-in period which will last up to 2 weeks, followed by 8 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 medication will be stopped for 1 day. The main assessment will be exercise tests on a treadmill, which will be performed three times; the first after the run-in, the second after the 8-week treatment period, and the last one at the final visit, after medication has been stopped for a day

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  08/H0402/157

• Date of REC Opinion

  13 Feb 2009

• REC opinion

  Further Information Favourable Opinion