An observational study in Hypertension, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 1 site in Austria. Open to participants aged Up to 54 Years. Per ClinicalTrials.gov, last updated 2014-07-31.
Sponsored by Merck KGaA, Darmstadt, Germany · Observational
The b.p.m study will be performed to gain the insight in the courses of illness and therapy in subjects, suffering from hypertension and that have elevated heart rate. This study will show that a therapy with bisoprolol (Concor/Concor PLUS) or any other blood pressure lowering (antihypertensive) drug lowers blood pressure (BP) and heart rate and increases the quality of subjects' life.
The b.p.m study measures heart rate development whilst treating subjects with hypertension with Concor [bisoprolol] or Concor Plus [bisoprolol + hydrochlorothiazide (HCTZ)].
The objectives of this study are:
After 6 months of the therapy treatment, 60% of the subjects showed a heart rate ≥ 80 beats/min.
An improved quality of life information after 6 months of therapy treatment, collected by asking standardised questions A decrease in systolic and diastolic BP after 6 months presented significant differences Digital sphygmomanometers (BP measuring devices) will be supplied in order to document the values of BP and heart rate. Blood pressure and heart rate should be measured at least 2 times, ideally 4 times per day. Furthermore, every subject will additionally receive a documentation sheet, where he/she will record the measurement data. The documentation sheet will be a part of the improvement of the quality of life; it can be removed and passed on.
Every subject will be explained how to use and handle the BP measuring device and the importance of the documentation. The assessment of the quality of life must be made at the beginning and at the end of 6 month therapy. Within the framework of the examination the attending physician will ask 8 standard questions (SQ-8 Short Form Health Survey). The questionnaire will be a part of the quality of life assessment.
The main focus of the observation is on the age group \< 55 years with concomitant diseases, such as diabetes or ketohexokinase (KHK).
6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.
This study's enrollment of 351 is above the median of 210 across 1,358 observational studies indexed under Hypertension.
Browse Hypertension studies →Merck KGaA, Darmstadt, Germany is the lead sponsor of 269 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Hypertensive subjects
Exclusion Criteria:
Film-coated tablets containing 5 mg or 10 mg of bisoprolol hemifumarate or film-coated tablets containing 5 mg of bisoprolol fumarate (2:1) and 12.5 mg of HCTZ were given
Also known as: Concor or Concor Plus
Improvement in heart rate
Time frame: Baseline to 6 months of therapy treatment
Changes in systolic and diastolic BP
Time frame: Baseline to 6 months of therapy treatment
Assessment of quality of life (SQ-8 Short Form Health Survey)
Time frame: Beginning and at the end of 6 month therapy
This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Merck KGaA, Darmstadt, Germany