Bayer 14727 randomised double blind hypertension study
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination Taken Orally for 8 Weeks in Adult Subjects with Essential Hypertension Who Are Inadequately Controlled on 16 mg Candesartan Cilexetil Monotherapy
IRAS ID
122904
Contact name
Peter Harvey
Contact email
Sponsor organisation
Bayer HealthCare AG
Eudract number
2012-004493-26
ISRCTN Number
n/a
Research summary
The purpose of this study is to assess the effectiveness of two doses of an experimental combination of drugs (Nifedipine Gastrointestinal Therapeutic System (GITS) and candesartan cilexetil) 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 safety and effect on lowering blood pressure of two different fixed dose combinations 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 7 times over a period of 14 weeks. This includes a one week screening period, a 5 week run-in treatment period and a further 8 weeks of treatment where participants will be randomly assigned to one of 3 different treatment options (candesartan cilexetil alone or one of two different fixed dose combinations). All participants currently on medication for high blood pressure will need to gradually stop taking this during the first week of the run-in treatment period. 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). Two or three times during the study, participants will be asked to wear a blood pressure monitoring device for a full 24 hour period, which will measure their blood pressure at regular intervals during the day.
The study is planned to take place at 13 GP practices in the UK, and at other centres worldwide.REC name
London - Riverside Research Ethics Committee
REC reference
13/LO/0710
Date of REC Opinion
10 Jun 2013
REC opinion
Favourable Opinion