Perindopril amlodipine vs valsartan amlodipine in hypertension

• Research type

  Research Study

• Full title

  Perindopril arginine/Amlodipine versus Valsartan/Amlodipine antihypertensive strategies: Efficacy and safety in mild to moderate hypertensive patients. A randomised, double blind 6-month study followed by 8-month open label long-term follow-up with Perindopril arginine/Amlodipine.

• IRAS ID

  66385

• Contact name

  Neil Poulter

• Sponsor organisation

  Servier Research & Development Ltd

• Eudract number

  2010-020945-28

• ISRCTN Number

  ISRCTN59214686

• Research summary

  Raised blood pressure (BP) or hypertension is a worldwide problem which left untreated increases the risk of life-threatening consequences such as having a heart attack or stroke. Once diagnosed treatment is started with 1 anti-hypertensive drug. If BP is not controlled the dose is increased and a second drug is added. Frequently patients require more than 1 drug to reach BP control. Unfortunately many treated patients do not achieve an optimal BP, partly due to drug side-effects and poor tablet taking. International guidelines for the management of hypertension endorse the development of tablets combining anti-hypertensive drugs into 1 pill to improve patient compliance and also for use as a starting therapy in some groups of patients. The drugs that are combined should have complimentary mechanisms of action and there should also be potential benefits such as reduced side effects. This trial concerns the development of new tablets combining perindopril and amlodipine. These 2 drugs have been used for more than 15 years and we know they are a safe and effective treatment for hypertension. Perindopril and amlodipine have been combined at new doses; lower starting doses than currently approved, which are then doubled for patients whose BP is not controlled. The new doses have been chosen to maximise the potential effectiveness of each drug when used together and also to reduce potential side effects, as well as reducing pill burden. The aim of this study is to test the effectiveness and safety of the new perindopril/amlodipine tablets/treatment strategy and to see if BP can be controlled more quickly by starting treatment with this combination of 2 drugs. To do this they will be compared against a standard treatment strategy starting with valsartan and then adding amlodipine. The second aim is to collect long-term safety data for the new perindopril/amlodipine tablets.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  10/H0305/77

• Date of REC Opinion

  3 Dec 2010

• REC opinion

  Favourable Opinion