Bayer 14801 Open Label Hypertension study

• Research type

  Research Study

• Full title

  Multicenter, Open-Label, Long-Term Safety and Efficacy Study of the Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Adult Subjects with Moderate to Severe Essential Hypertension

• IRAS ID

  118872

• Contact name

  John Robinson

• Sponsor organisation

  Bayer HealthCare AG

• Eudract number

  2012-004515-32

• Research summary

  The purpose of this study is to assess if an experimental combination of drugs (Nifedipine Gastrointestinal Therapeutic System (GITS) and candesartan cilexetil) is safe and effective in treating patients with persistent high blood Pressure (essential hypertension). Both drugs that are being investigated are currently approved for use in patients with high blood Pressure alone or together with other antihypertensive drugs, but this study will investigate the long term safety and effect on lowering blood Pressure of a fixed dose combination of the drugs together in one tablet. About 500 adults, age 18 and over, with high blood Pressure will take part in the study. Participants will take the study drug daily and visit their study doctor 8 or 11 times over a period of approximately either 30 weeks (7 months) or 54 weeks (one year and 2 weeks). Participants will receive study treatment for either 28 or 52 weeks (the first 200 patients will receive 52 weeks treatment). All Participants currently on medication for high blood Pressure will need to gradually stop taking this before starting study treatment. Participants will need to fast for up to 12 hours before some study visits and assessments at the study visits may include blood tests, physical examinations, blood Pressure measurements and electrocardiograms (ECG - an electrical tracing of the heart). The study is planned to take place at 12 centres in the UK (both independent research centres and GP practices), and at other centres worldwide.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  13/NW/0004

• Date of REC Opinion

  8 Feb 2013

• REC opinion

  Further Information Favourable Opinion