Polypill Prevention Trial 1 (PPT01)

• Research type

  Research Study

• Full title

  A randomised, placebo controlled, double-blind, cross-over trial of the Polypill on risk factor reduction

• IRAS ID

  51383

• Contact name

  David Wald

• Sponsor organisation

  Head of Research Resources

• Eudract number

  2010-019874-34

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The objective is to determine the reduction in serum cholesterol and blood pressure using the Polypill and to assess the prevalence of adverse effects. The study will adopt a double blind cross-over design with three months on the Polypill and 3 months on placebo in random order. The Polypill or an identical placebo would be taken once a day (in the evening because simvastatin is more effective when taken in the evening than the morning). A cross-over trial offers the statistically most powerful method of determining the effect of the Polypill on risk factor modification (the cross-over design ensuring that each person is his/her own control). The design allows for a 20% non-completion rate. At the end of the trial participants who have completed both cross-over phases will continue to receive the Polypill on a named patient basis for a period of monitoring (2 years) of adverse effects.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  10/H0717/66

• Date of REC Opinion

  29 Sep 2010

• REC opinion

  Further Information Favourable Opinion